APPLICATION REGARDING CRITICIAL CANCER TOPIC 1-5 (PICK ONE)
1. Increase the efficacy of cancer diagnostics and therapeutics through targeted and personalized medicine
2. Develop approaches for metastatic disease with broad applicability to multiple cancers
3. Develop technologies or therapeutic approaches to overcoming drug resistance of refractory cancers
4. Improve quality of life: a) new curative approaches with immediate impact on the quality of life of patients; or b) address late effects and long-term outcomes of cancer therapies
5. Use of repurposed drugs and devices to quickly find safe and affordable treatments for both common and rare cancers.
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0. GENERAL INFORMATION
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2
Prepared by (name, address):
Date of this proposal:
Proposed trial title:
Type of trial:
[Text]
[Text]
[Text]
Phase I
Cohort
Cat. A
Yes
Phase II
Other: [Text]
Phase III
Cat. B Cat C
No
N/A 5
6
7
8
HFA  IMP Category
HFA  genetic modified organism?
HFA  other Health intervention
HFA  non-clinical trial
I. TRIAL TEAM
9 Designated coordinating investigator:
10 Designated supporting coordinating investigator:
11 Further investigators of other disciplines involved:
12 Project group/working group/section involved:
Cat. A
Yes
[Text]
[Text]
[Text]
[Text]
Cat. B
No
N/A
Trial Proposal Form page 1/4

II. TRIAL BACKGROUND
13 Rationale:
Including reasoning for design, randomization, etc.
[Text]
14 Current standard therapy:
[Text]
15 Why is a trial needed now?
[Text]
16 Are there competing trials?
Check trial registries, e.g. http://www.cancer.gov/clinicaltrials
[Text]
17 If the proposed trial is positive, what further studies do you plan?
[Text]
18 What is the relevance of the trial
- for patients?
- for the scientific community?
- for companies/grant providers?
[Text]
III. OBJECTIVE, ENDPOINTS AND STATISTICS
19 Main objective of the trial:
[Text]
20 Primary endpoint: please provide definitions
[Text]
21 Secondary endpoints: please provide definitions
[Text]
22 Proposed trial design:
[Text]
23 Parameters (i.e. null hypothesis, alternative hypothesis, significance level, power, number of interim analyses, early stopping rule, etc.) of the statistical design and required sample size.
[Text]
24 Any subgroup analyses planned:
[Text]
IV. POPULATION AND TREATMENT
25 Diagnosis and disease status of the population under study:
[Text]
26 Principal eligibility criteria:
INCLUSION CRITERIA:
[Text]
EXCLUSION CRITERIA:
[Text]
27 Planned trial interventions (including doses and schedule): provide a chart
Trial Proposal Form page 2/4

[Text]
28 Proposed treatment duration:
[Text]
29 Planned efficacy assessments:
[Text]
30 Planned safety assessments:
[Text]
V. FINANCIAL CONSIDERATIONS
31 Are all drugs registered in this indication?
[Text]
32 Has an involved company been contacted?
[Text]
33 Drugs provided by the company:
[Text]
34 Funding strategy: Which grant providers do you plan to contact? (if applicable)
[Text]
35 Investigations added by the trial to the usual medical practice for this disease (may not be covered by insurances):
Please check with different centers and foreign centers
[Text]
36 Proposed frequency and duration of follow-up:
[Text]
VI. SUBSTUDIES - Are any of the following substudies planned (please include hypotheses and statistical considerations)?
37 Quality of life (QL)
If yes, contact the QL office.
[Text]
38 Health economics studies:
[Text]
39 Laboratory studies:
If yes, please name laboratory and responsible person:
[Text]
40 Pathology studies:
If yes, please name pathology institute and responsible person
[Text]
41 Tissue banking:
If yes, please name pathology institute and responsible person
[Text]
Trial Proposal Form page 3/4

VII. PARTICIPATING SITES AND EXPECTED ACCRUAL
42 Site participation
43 Is sufficient accrual guaranteed?
Please detail the expected accrual.
restricted, specify maximal amount of site allowed to participate: _____________
open (every interested site should be allowed to participate)
[Text]
VIII. EXPECTED MILESTONES
44 Milestone (realistic estimates)
Assessment and approval by the research organization’s Board
Start protocol development
Core protocol
Final protocol/CRF
Trial activation (regulatory approval), first patient in
End of accrual (last patient in)
Last patient last treatment
Data maturity
Expected date of final study report and manuscript
(i.e. 6-9 months after data maturity)
IX. PUBLICATION STRATEGY
[Text] 45 At which congress do you plan to present an abstract?
46 Where do you plan to publish 
Journal
[Text]
X. FINAL REMARKS
47 Risk assessment: what are the critical aspects of the proposed trial?
[Text]
48 Any additional explanation / justification that did not fit the sections above
[Text]
49 Important references
Please add PDF copies of the most important articles to the proposal (max. 5)
[Text]
Quarter / year
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