ATTom study Design
ATTom – Adjuvant Tamoxifen Treatment offer more?
ATTom is a very large, uniquely simple randomised study of the effects of prolonging
adjuvant tamoxifen on the survival of patients with operable breast cancer
Breast carcinoma completely
excised
Any primary treatment
At least 2 years prior tamoxifen
treatment
Clinically relapse free
Definitely
NO
Patient is
NOT
Eligible
Is further Tamoxifen
indicated at this time?
UNCERTAIN
whether to continue or not
Definitely
YES
Reconsider
randomisation
later
RANDOMISE
STOP
tamoxifen
now
Eligibility Criteria:
CONTINUE
for a further 5
years
Exclusion Criteria:
Any woman who is clinically relapse free, and who
is currently taking tamoxifen can join the aTTom
study.
Definite contraindications to tamoxifen are not
specified by the protocol,
but might include:
The patient is eligible if there are thought not to be
any clear indications for or definite contraindications
against further tamoxifen, and hence substantial
uncertainty exists at to stop or continue treatment.
Intended or actual pregnancy or breastfeeding
Significant endometrial hyperplasia
Retinopathy
Need for anti-coagulant therapy.
Serious toxicity (eg. Depression) thought due to
tamoxifen
or
Negligibly low risk of breast cancer death
Some major life threatening disease other than breast
cancer (such that management of breast cancer is not
the main concern)
Low probability of treatment compliance (eg.
psychiatric disorders, or extreme old age).
Women who have received any type of initial
surgery who have received any other type of
adjuvant treatment are eligible for aTTom. Women
may have node positive or node negative disease, be
pre or post-menopausal, and have ER positive or ER
negative tumours, etc.
SECRAB Study Design
SEquencing of Chemotherapy and Radiotherapy in Adjuvant Breast cancer
A large randomised clinical trial designed to determine the optimum sequencing of
chemotherapy and radiotherapy in the adjuvant treatment of early breast cancer
Women with early breast cancer
having adjuvant chemotherapy
and radiotherapy following
conserving surgery or
mastectomy
Confirm eligibility
Prescribe appropriate CT and RT regimens
Decide if a Boost dose will be given
Obtain informed consent
Randomise
Sequential Schedule
Synchronous Schedule
Chemotherapy followed
by Radiotherapy
Chemotherapy
Radiotherapy
Chemotherapy
Annual follow-up for five years
(relapse and survival status)
Eligibility Criteria:
Histological diagnosis of invasive, unilateral breast carcinoma.
Wide local excision or mastectomy with macroscopic complete excision of clinically early stage
disease with no evidence of metastases.
There is a clear indication for both adjuvant chemotherapy and radiotherapy, or the patient has been
randomised to these treatments in another study.
The intended schedules can be given synchronously and the patient is suitable for either treatment
schedule.
No prior chemotherapy (other than hormone manipulation).
No prior malignancy (except skin basal/squamous cell or in situ carcinoma).
No other medical or social contraindication to entry and follow-up.
DEVA – Study Design
Sequential Epirubicin & Docetaxel vs Epirubicin alone in postmenopausal primary breast cancer
Eligible patients
Post-menopausal
Node positive breast cancer
No distant metastases
Completely resected
Randomisation
EPIRUBICIN 50mg/m2
Day 1 & Day 8
6x cycles 4-weekly
EPIRUBICIN 50mg/m2
Day 1 and Day 8
3x cycles 4-weekly
Followed by:
DOCETAXEL 100mg/m2
Day 1
3x 3-weekly cycles
*TAMOXIFEN (sequential vs concurrent)
Centres not partaking in
sequential vs concurrent
tamoxifen
Sequential
tamoxifen for
5 years
Concurrent
Tamoxifen
for 5 years
Concurrent
tamoxifen for
5 years
Follow up prior to each course of chemotherapy, and months 9 & 12. Then
months 16, 20, 24, 30, 36, 42, 48, and annually thereafter
Eligibility Criteria:
Postmenopausal, histologically proven node positive breast cancer
No evidence of metastases
WHO performance status 0 or 1 & Biochemistry within normal limits:
WBC 3x109/l or ANC1.5 x 109/l
Platelets  100 109/l
Normal Bilirubin
SCGOT, SGPT and alkaline phosphatase  1.5 x normal, serum Creatinine <1.5 x normal.
(for patients allocated to epirubicin followed by docetaxel, the LFTs should be checked again
prior to commencing treatment with docetaxel)
No significant cardiac disease (ECG and/or LVEF by MUGA scan/echocardiography). Centres
should inform the Data centre of the type of assessment intended for all patients randomised
*For ER- & PgR- patients, tamoxifen treatment id according to discretion of the clinician.
FOCUS Study Design
Fluorouracil, Oxaliplatin and Irinotecan: Use and Sequencing
A randomised trial to assess the role of irinotecan and oxaliplatin in advanced colorectal
cancer
Eligible patient: advanced colorectal cancer, not previously
treated with chemotherapy for metastatic disease
Randomise
Plan A
Plan B
MdG
until
progression
MdG
until
progression
Second-line
single agent
irinotecan
Second-line
IrMdG
Plan C
Plan D
IrMdG
until
progression
MdG
until
progression
Plan E
OxMdG until
progression
Second-line
OxMdG
Upon progression, management at the clinician’s discretion, usually supportive care alone. If further
chemotherapy is to be used, use a non-crossover regimen. PVI 5FU + mitomycin is recommended
Abbreviations:
MdG – Modified de Gramont
IrMdG – Modified de Gramont + irinotecan
OxMdG – Modified de Gramont + oxaliplatin
Eligibility Criteria:
Exclusion Criteria:
Histologically confirmed adenocarcinoma of the colon or
rectum
Inoperable metastatic or locoregional disease
No previous chemotherapy for established metastatic
disease (if adjuvant chemo was give previously, it may
have included 5FU but not oxaliplatin or irinotecan, and
must have been completed >6months prior to trial entry)
Measurable disease (RECIST classification)
WBC>4 x109/l, platelet count >150 x 109/l, Bilirubin
<1.25 upper limit of normal(ULN) and ALP<5 x ULN
GFR>50ml/min
WHO PS 0, 1 or 2
WOCBP negative pregnancy test & adequate contraceptive
precautions
Concurrent uncontrolled medical illness, or other
current malignant disease likely to interfere with
protocol treatments or comparisons
Partial or complete bowel obstruction
Age<18. No fixed upper age limit, use precaution in
selection of elderly patients
Pre-existing neuropathy (>grade1)
Chronic diarrhoea or inflammatory bowel disease
Gilbert’s Syndrome or other congenital abnormality of
biliary transport
Previous
transplant
surgery,
requiring
immunosuppressive therapy (due to interaction of
cyclosporin-A with irinotecan
Unable to comply with QoL assessment
VICTOR Study Design
VIOXX in Colorectal Cancer Therapy: definition of Optimal
Regime
Randomised, double blind, placebo-controlled study or Rofecoxib (VIOXX)
in colorectal cancer patients following potentially curative therapy
Patient fulfils eligibility
criteria
Randomise
VIOXX
2 years
PLACEBO
5 years
2 years
5 years
Eligibility Criteria:
Exclusion Criteria:
Histologically proven Dukes C (stage III: any T, N12, M0) or B (stage II: T 3or 4, N0, M0) colorectal
carcinoma
Patients must have undergone complete resection of
the primary tumour without gross or microscopic
evidence of residual disease
WHO PS 0 or 1
ANCx 109/l, platelets >100 x 109/l, Bilirubin
AST/ALT 1.5 x upper limit of normal,
GFR>30ml/min. Tests to be carried out  2 weeks
prior to randomisation
Within 12 weeks of finishing potentially curative
therapy (surgery alone, or surgery + Radiotherapy
+/- Chemotherapy
Patients with active peptic ulceration or GI
bleeding in the last year
Past history of adverse reaction to NSAID eg.
Asthma, acute rhinitis, nasal polyps, angioneurotic
oedema or urticaria
Known sensitivity to VIOXX
Long-term NSAID therapy (except low dose
aspirin)
<18 years of age
Pregnancy or lactation
Previous malignancies other then adequately
treated in situ carcinoma of the uterine cervix or
basal or squamous cell carcinoma of the skin,
unless there has been a disease free interval for at
least 10 years
Inflammatory bowel disease
Severe congestive heart failure
GELCAPS Study Design
Genetic Lung Cancer Predisposition Study
Patients diagnosed with lung
cancer
Partner of patient
(wherever possible)
Lifestyle questionnaire
Blood sample taken for
analysis at trial centre
All patients who have been diagnosed with lung cancer, irrespective of whether
the patient smokes are eligible. (Adenocarcinoma must be histologically proven
from bronchial biopsy or surgical resection)
NSCLC must be specified cell type eg. Squamous
Patients may enter the study at any time after diagnosis
The partner of the patient includes spouse, same sex partner or other
unrelated adult living long term in the same house as the patient.
The partner must not have developed a smoking related malignancy
Smoking and non-smoking partners are eligible for entry into the study
At the time of sampling, the patient must have WBC at least 2x109/l. It is
not necessary to routinely check the partners’ WBC
It is vital for the success of GELCAPS that a group B partner is
recruited to GELCAPS wherever possible
MESO-1 Study Design
Randomised feasibility study of active symptom control with or without chemotherapy in the treatment of
patients with mesothelioma
Patient with diagnosis of mesothelioma
Registration
Eligible?
YES
NO
No further information is
required regarding this patient
Randomise
ASC
ASC + MVP
ASC + N
Patients are followed up every 8 weeks until death.
QoL should be completed by every patient - prior to being informed of their allocated treatment
ASC: Active symptom control
MVP:Mitomycin (8 mg/m2), vinblastine (6mg/m2) and cisplatin (50 mg/m2) to be given every 21
days with a total of 4 cycles
N: 6 weekly injections of vinorelbine (30 mg/m2) followed by a 2-week interval before a further
course of 6 weekly injections
Eligibility criteria:
Microscopically and immunohistochemically confirmed malignant mesothelioma, including
epithelial and other histological types.
Any symptomatic pleural effusion treated and brought under control by drainage, pleurodesis
or pleurectomy before trial entry.
CT scan to be performed within a month prior to randomisation and, wherever possible, after
pleurodesis.
Patients who have undergone surgical resection of mesothelioma are eligible provided 2 CT
scans, 6 weeks apart; show stable or progressive disease which is assessable.
No previous chemotherapy for mesothelioma.
No other disease or previous malignancy likely to interfere with protocol treatments or
comparisons.
WHO status 0-2.
WBC>3x109/l, neutrophils>1.5x109/l, platelets>100x109/l, and there is no clinical evidence of
infection.
Considered medically fit to receive chemotherapy.
Patient has completed QoL forms prior to being informed of treatment allocated.
MALCS Study Design
A population based case-control study of mesothelioma and lung cancer in
relation to occupation among British men and women under the age of 60
Mesothelioma & resected lung
cancer patients aged under
60 years
Obtain informed consent
Telephone interview
conducted by Institute of
Cancer research
Lung sample obtained post
mortem
All mesothelioma & resected lung cancer patients aged  60 years, registered
with a GP
Not to have worked outside the UK for longer then 1 year (except members of
the Armed Forces, who will be included regardless of where they were
stationed) this doesn’t include living abroad as a child.
Telephone owners (not ex-directory)
GP informed & permission sought for patients’ inclusion.
Telephone interviews are conducted by researchers at the Institute of Cancer
Research
Post mortem lung samples will be provided by relevant pathologist to trial
centre & examined for fibre content
LU22 Study Design
Randomised trial of surgical resection with or without pre-operative
chemotherapy in patients with operable non-small cell lung cancer (NSCLC) or
any stage
Resectable NSCLC
First QoL form completed
Randomised
Surgery
Chemotherapy &
surgery
Chemotherapy schedules:
MVP: Vinblastine 6mg/m2, and cisplatin 50mg/m2 at 3-week intervals for 3 cycles,
with Mitomycin 8 mg/2
MIC: Same as MVP but with ifosfamide 3g/m2 instead of vinblastine
NP: Vinorelbine (Navelbine) 30 mg/m2 on days 1 and 8 and cisplatin 80 mg.m2 on
day 1 at 3-week intervals for 3 cycles
Eligibility Criteria:
Previously untreated NSCLC, microscopically proven from biopsy or cytology
Tumour considered resectable by surgeon
No evidence of distant metastases
No contra-indication to chemotherapy or surgery
No disease or previous malignancy likely to interfere with the protocol
treatments or comparisons.
Clinical and CT staging for all patients
Mediastinoscopy for patients with possible N2 or T3N1 disease on CT scan.
Then, only patients with pN0 or single-station nodal involvement should be
considered.
POSH Study Design
Prospective Outcomes in Sporadic vs. Hereditary breast cancer
Patient is 40 years old
Invasive breast cancer
Check eligibility
Obtain informed consent
Blood sample is taken & sent to
trial centre for DNA analysis
(before surgery if possible)
Fresh tumour sample sent to
trial centre if patient has
strong family history
OR
Family history questionnaire
completed
Representative pathology
block sent temporarily to trial
centre if no fresh sample
taken
Follow-up questionnaires at 6 and 12 months, then annually
thereafter
Neither patients nor clinicians will be informed of patients’ BRCA status. Patients
who wish to have genetic counselling may be referred to:
Dr Fiona Douglas
Consultant Clinical Geneticist
Institute of Human Genetics
International Centre for Life
Central Parkway
Newcastle upon Tyne
NE1 3BZ
Tel 0191 2418725
www.taxol-uk.com Study Design
Will Weekly Win for Taxol in the UK: Comparison of Outcomes in Metastatic and
locally advanced breast cancer with weekly vs. 3-weekly administration of Paclitaxel
Patients with locally advanced or
metastatic breast carcinoma
Prior treatment with
anthracyclines (or contraindication to anthracycline use)
Confirm eligibility
Obtain informed consent
Randomise
Paclitaxel: 90mg/m2 IV
over 1 hour on day 1
every week
Paclitaxel: 175mg/m2
IV over 3 hours on day
1 every 3 weeks
Follow-up every 3 months for 2 years and every
6 months thereafter
Eligibility Criteria:
Exclusion Criteria:
Histologically proven breast carcinoma
Locally advanced or metastatic disease
Presence of at least one measurable lesion
Prior treatment with anthracyclines (either given as
adjuvant treatment for metastatic disease) or a contraindication to anthracycline use
No radiotherapy to indicator lesions within 3 months of
randomisation
Immunotherapy and/or hormone therapy must be
discontinued prior to study start
Male or female, aged 18-80 years inclusive
WHO PS 0-2
Adequate haematological, renal & hepatic function
Patient must be accessible for treatment and follow-up
Prior Taxane treatment
Previous malignancies, excluding curatively treated
squamous cell carcinoma of the skin, in situ cervical cancer
or any other cancer treated more than 5 years prior to study
entry , and presumed cured.
Uncontrolled arterial hypertension
Active infection or other serious underlying medical
condition that would impair the ability of the patient to
receive protocol treatment
Symptomatic brain metastases
Patients with no measurable or evaluable disease
Pre-existing motor or sensory neurotoxicity > grade 1
Dementia or significantly altered mental status
Any investigational drug given within 30 days of initiation
of therapy, or participation in other systemic anti cancer
therapy or bisphosphonate studies while enrolled in this
protocol
TEAM study Design
(CLOSED TO RECRUITMENT END MAY 2003)
Comparative trial of 5 years adjuvant Exemestane treatment vs. 5 years
adjuvant Tamoxifen treatment in postmenopausal women with early breast
cancer
Node +ve or high-risk node -ve
ER or PgR +ve
Curative surgery
(adjuvant chemotherapy where indicated)
Check eligibility
Obtain informed consent
Randomisation within 10 weeks of
completing surgery +/- adjuvant
chemotherapy
TAMOXIFEN
20 mg o.d.
5 years
EXEMESTANE
25 mg o.d.
5 years
Eligibility Criteria:
Exclusion Criteria:
Histologically/cytologically confirmed early
adenocarcinoma
Any node POSITIVE
or
Any primary tumour >3cm or
Any primary tumour grade II or III>1cm
ER and PgR +ve
Postmenopausal
No evidence of metastases
HRT must be discontinued at least 4 weeks prior to
randomisation
Adequate haematological, renal and hepatic function
ECOG PS 0-2
Within 10 weeks of completing surgery +/- adjuvant
chemotherapy
Chest X-ray clear of metastases
Positive supraclavicular nodes
Evidence of distant metastases
Chemotherapy started more than 10 weeks after completion of
primary surgery
Previous hormonal treatment as adjuvant treatment for breast
cancer
Neo-adjuvant hormone therapy >4 weeks duration prior to
surgery
Severe osteoporosis
Uncontrolled cardiac disease including angina, CHF or
arrhythmia requiring medical therapy or history of MI in past 3
months, or any other serious concomitant disease.
Psychiatric disorders preventing proper informed consent
Concomitant malignancies (except adequately treated carcinoma
in situ of the uterine cervix or basal cell carcinoma of the skin).
Patients with other malignancies must be disease free for at least
5 years.
Concurrent participation in another clinical study involving
investigational agents that may interfere with the results of this
trial.
Other serious illness that may interfere with subject compliance,
adequate informed consent or determination of causality of
adverse events.
Patients on HRT, which was not discontinued at least 4 weeks
prior to randomisation
SPROG – Study Design
G-CSF secondary prophylaxis in the chemotherapy of early breast cancer
Eligible patient
Early stage breast cancer
Patient receiving chemotherapy
Eg.CMF, DOX CMF, FEC, Taxane Regimen
Patient experienced first neutropenic event
Randomise
G-CSF (Filgrastim) secondary
prophylaxis 5g/kg from day 3 post
chemotherapy until day 9 (ie, 7
days). Administer after each cycle
(last day of chemo = Day 1)
Conservative management (dose
modification as per protocol)
Record incidence of
neutropenic events and evaluate
dose intensity received
End of treatment
assessment
Eligibility Criteria:
Exclusion Criteria:
18 years of age or older
Histologically confirmed invasive breast cancer
No concomitant malignancy
No prior chemotherapy apart from the current regimen
(prior tamoxifen DOES NOT exclude a patient from
this study)
Previous neutropenic event on adjuvant iv
chemotherapy & considered of suitable risk and fitness
to continue chemotherapy
Written informed consent
Patients with locally advanced or metastatic
breast cancer, including supraclavicular fossa
metastases
Receiving sandwich/synchronous radiotherapy
(defined as radiotherapy administered during a
break in the chemotherapy regimen) – patients
receiving concomitant radiotherapy during
chemotherapy are NOT excluded
Direct irradiation of the internal mammary
chain
Receiving CMF in the oral Day 1 –14 schedule
Previous exposure to G-CSF
TANGO – Study Design
Paclitaxel, Anthracyline, Gemcitabine & Cyclophosphamide
Operable Breast Cancer
Clear Resection Margins
Any nodal status
ER negative/weakly positive or
ER positive and PgR negative/weakly
positive
RANDOMISATION
Control Arm
Epirubicin 90mg/m2
Slow push/fast drip, day 1 only
Cyclophosphamide 600mg/m2
Slow push, day 1 only
Research Arm
x4 cycles
3-weekly
intervals
Followed by:
Paclitaxel 175mg/m2
3 hr infusion, day 1 only
Epirubicin 90 mg/m2
Slow push/fast drip, day 1 only
Cyclophosphamide 600mg/m2
Slow push, day 1 only
x4 cycles
3-weekly
intervals
Followed by:
x4 cycles
3-weekly
intervals
Paclitaxel 175mg/m2
3 hr infusion, day 1 only
Gemcitabine 1250mg/m2
0.5hr infusion, days 1 and 8
Annual follow-up
Details of any recurrence, survival status, date and cause of death
if patient has died
Eligibility Criteria:
Histologically proven, early stage, completely resected invasive breast carcinoma
Definite indication for adjuvant chemotherapy
Any nodal status
ER negative/weakly positive or ER positive and PgR negative/weakly positive
No contraindication to anthracyclines
Radiotherapy intent is known
No previous malignancy
x4 cycles
3-weekly
intervals
ONCOLOGY
CLINICAL TRIALS
Inclusion/exclusion criteria for all
current NCRN approved clinical
trials
If you have a patient who may be eligible
for one of the NCRN clinical trials in our
portfolio, please contact:
Christine Harle
NCRN Clinical Trials Officer
Ext 42329 or Bleep 52424
QUASAR 1 Study Design
Dukes B or C Colorectal Cancer
Uncertain indication for chemotherapy
6 months adjuvant
chemotherapy with
5FU = low-dose
folinic acid
Observation only –
with chemotherapy
considered on
recurrence
Any patient who has undergone apparently curative surgery for colorectal cancer
with histologically proven Dukes B or C Colorectal Carcinoma
No distant metastases
No definite clear indication for, or against systemic chemotherapy
Definite contraindications to chemotherapy are not specified by the protocol but by the
responsible physician and might include:
Either
Conditions associated with high risk of adverse events such as:
Persistently low blood counts
Moderate renal or hepatic insufficiency
Recent myocardial infarction, stroke or other serious
cardiovascular disease
Poor general health
Pregnancy
Or
Conditions associated with only a small likelihood of worthwhile benefit,
such as:
Negligibly low risk of colorectal cancer death
Some major life threatening disease other than colorectal cancer
Low probability of treatment compliance (eg psychiatric disorders,
extreme old age)
LLCG Study 12 – Study Summary
Phase III randomised, double blind, and placebo-controlled trial of Carboplatin/Etoposide with or
without thalidomide in Small Cell Lung Cancer
Patients with SCLC
PS 0-3
Etoposide & Carboplatin 3 weekly/6 cycles
Day 1 Etoposide 120mg/m2 IV in 1l Saline over
60-120mins
Days 2 & 3 Etoposide 100mg bd orally
Day 1 Carboplatin (AUC 5 EDTA or AUC 6
Cockcroft) in 500ml 5% dextrose over 30mins
CXR/CT at baseline &
repeated before
chemotherapy cycles 2,3,4,5
& 6 (if CT, repeat after
cycles 3 & 6)
History, physical
examination, blood tests
done before each
chemotherapy cycle
Thalidomide/placebo
During chemotherapy - 100mg
Post chemotherapy for 1 month – 150mg
Subsequent follow-up (up to 24 months)– 200mg
Eligibility Criteria:
Histologically or cytologically confirmed SCLC
Limited or extensive disease
Male or female aged >18 years
ECOG performance status 0-3
Estimated life expectancy >8 weeks
Adequate renal function for Chemotherapy (EDTA clearance  60ml/min)
WOCBP must practice complete abstinence from heterosexual intercourse or to use TWO methods of
contraception whilst on study medication & for 4 weeks after the last dose of study medication.
WOCBP must have negative serum/urine pregnancy test in 24hrs before starting study medication.
Pregnancy tests must be repeated every 4 weeks until 4 weeks after medication is finished.
Male patients must use barrier contraception (including those who have had a vasectomy)
Exclusion Criteria:
Pregnancy or lactation
Life expectancy <8weeks
ECOG Performance status 4
Prior chemotherapy/radiotherapy
Evidence of significant medical condition that would make it undesirable for the patient to participate
Symptomatic brain metastases throughout to require immediate radiotherapy
History of malignant tumour, unless the patient has been disease free for at least 3 years, or the tumour
was non-melanoma skin tumour or early cervical cancer
LLCG Study 14 – Study Summary
Phase II/III randomised double blind, placebo controlled trial of Gemcitabine/Carboplatin with or
without thalidomide in advanced Non-Small cell Lung Cancer
Patients with NSCLC
Stage IIIb or IV disease
PS 0-2
Gemcitabine and Carboplatin - 3 weekly/4 cycles
Day 1 Gemcitabine 1200mg/m2 IV in 250ml saline over
30mins
followed by
Carboplatin *mg(AUC) IV in 500ml dextrose over
30mins
Day 8 Gemcitabine 1200mg2 IV in 250ml saline over 30
minutes
Thalidomide/placebo
During chemotherapy - 100mg
Post chemotherapy for 1 month – 150mg
Subsequent follow-up (up to 24 months)– 200mg
CXR/CT at baseline &
repeated before
chemotherapy cycles 2,3,4,5
& 6 (if CT, repeat after
cycles 3 & 6)
History, physical
examination, blood tests
done before each
chemotherapy cycle
*Carboplatin dose calculated in mg according to the formula:
Dose=Target area under curve x (creatinine clearance +25) IV day 1
Eligibility Criteria:
Histologically or cytologically confirmed NSCLC
Limited or extensive disease
Male or female aged >18 years
ECOG performance status 0-3
Estimated life expectancy >8 weeks
Adequate renal function for Chemotherapy (EDTA clearance  60ml/min)
WOCBP must practice complete abstinence from heterosexual intercourse or to use TWO methods of
contraception whilst on study medication & for 4 weeks after the last dose of study medication.
WOCBP must have negative serum/urine pregnancy test in 24hrs before starting study medication.
Pregnancy tests must be repeated every 4 weeks until 4 weeks after medication is finished.
Male patients must use barrier contraception (including those who have had a vasectomy)
Adequate bone marrow reserve
Exclusion Criteria:
Pregnancy or lactation
Life expectancy <8weeks
ECOG Performance status 3 or 4
Prior chemotherapy/radiotherapy
Evidence of significant medical condition that would make it undesirable for the patient to participate
Symptomatic brain metastases throughout to require immediate radiotherapy
History of malignant tumour, unless the patient has been disease free for at least 3 years, or the tumour
was non-melanoma skin tumour or early cervical cancer
PRIME – Study Summary
Postoperative Radiotherapy in Minimum risk Elderly
Age >65 years, TNM stages T0-2
Axillary node negative
Breast conserving surgery
No definite indications for or
against radiotherapy
RANDOMISE
Radiotherapy
No Radiotherapy
Patients not participating in
randomisation for treatment
can still take part in QoL
questionnaire
Assessments:
2 weeks after radiotherapy
completed, or equivalent time
post-surgery (home visit by
PRIME nurse)
3.5 months post-surgery (clinic)
8 months post-surgery (clinic)
9 months post-surgery (home)
12 months post-surgery (clinic)
15 months post-surgery (home)
Long-term follow-up
Eligibility Criteria:
Aged 65 years or more, receiving adjuvant endocrine therapy
Medically suitable to attend for all treatments and follow-ups
Histologically confirmed unilateral breast cancer of TNM stages 0-2
No axillary node involvement on histological assessment
Had breast conserving surgery with complete excision on histological assessment
Able and willing to give informed consent
Exclusion Criteria:
Past history of pure in situ carcinoma of either breast or previous or concurrent malignancy other
than non-melanomatous skin cancer or carcinoma in situ of cervix.
Grade III cancer with lymphatic/vascular invasion (because of higher risk of local recurrence)
All home visits are carried out by the PRIME study research nurse,
National Study of Colorectal Cancer Genetics – Study Summary
To determine the contribution of mutations in known genes to the incidence of
colorectal cancer, and derive a genetic model of residual familial risks.
All patients diagnosed with
histologically confirmed
colorectal cancer
Non-blood relative/friend of
patient to act as control
Patient gives blood sample & answers family
history questionnaire
Control subject supplies blood sample and
questionnaire
All patients with a diagnosis of colorectal cancer are eligible, and may enter the study
at any time after diagnosis.
Controls should be recruited for each patient, these should be non-blood relations of
the patient, e.g. partner, or a friend. Controls should not have developed any
malignancy.
No Genetic test results will be made available to study participants, or clinicians. If
patients wish to have genetic counselling, the should be referred to:
Dr Fiona Douglas
Consultant Clinical Geneticist
Institute of Human Genetics
International Centre for Life
Central Parkway
Newcastle upon Tyne
NE1 3BZ
Tel 0191 2418725