Community_________________
Pt. Case #__________________
Date of Site Visit_____________
Pt. Initials__________________
1st Randomization Date___________
2nd Randomization Date___________
Treatment Start Date_____________
Group Assignment___________
Consent Date_______________
Version Date_______________
Date of Birth_______________
RTOG 0848 (Pancreas)
Eligibility
Path confirm primary adenoca head of pancreas managed w/ potentially
curative resection (Whipple) Op Note must state complete gross excision
of primary tumor achieved. Path rpt incude doc. Of margin status/size of
tumor w/ status of 3 major marins (bile duct/pancreatic
parenchyma/retroperitoneal)
Interval between tumor surg and 1st registration 21-56 days
Stg. T1-3 N0-1, M0
PS≤1
ANC ≥ 1,500
Plts ≥100,000
HGB ≥ 8.0 (use of transfusion to achieve HGB ≥8.0 acceptable)
Creat ≤ 2 x ULN
Bili ≤ 1.5 x ULN
SGOT ≤ 3 x ULN
Neg. serum pregnancy test
Post-resection serum CA19-9 ≤180units/mL
Ineligibility
Non-adenocarcinormas,adeno,islet cell,cystadenomas,,
carcinoid,duodenal,distal bile duct, ampullary ca
Managed w/ total pancreatectomy, distal or central pancreatectomy
Prior systemic chemo for pancreatic ca(prior chemo for other ca OK)
Prior RT to current region
Prior invasive malignancy unless dis free 2 yrs
COPD req. hospitalization at registration
Surg margin status cannot be determined after consultation w/
surgeon/pathologist
Hx MI w/in 3 mos.
Unstable angina/CHF w/in last 6 mos.
Acute bact/fungal infect. Req IV antibiotics at reg
Pregnant/Nursing
Pre- treatment – 31 Days Prior to Registration Date___________
H+P
Date____________
Wt. + vitals
Date____________
CT/MRI abd/pelvis
Date____________
Chest CT or CXR
Date____________
1
Yes
No
N/A
Community_________________
Pt. Case #__________________
Date of Site Visit_____________
Pt. Initials__________________
1st Randomization Date___________
2nd Randomization Date___________
Treatment Start Date_____________
Group Assignment___________
Consent Date_______________
Version Date_______________
Date of Birth_______________
RTOG 0848
Pre-treatment – 21 days prior to Registration
Date______________
CDP/ANC
Date____________
Na, K, BUN,Creat, Glucose
Date____________
Bili, SGOT,Cl, Co2
Date____________
Post-Op CA 19-9
Date_______________
Tissue/Blood/Urine Submission is Mandatory
Date Submitted____________
Pre-treatment – 14 days prior to registration
PS
Date____________
Preg. Test(serum)
Date____________
Date________________
Erlotinib Provided
ARM 1
ARM 2
Gemcitabine 1000mg/m2/week x 3 weeks then off 1 week x 5 cycles
Gemcitabine 1000mg/m2/week x 3 weeks then off 1 week x 5 cycles +
Erlotinib 100mg PO/day x 5 cycles until CT/MRI evaluation for progression
C#1 Days 1, 8, 15
CDP/ANC/AE Eval________Date Gemcitabine Dose__________Date__________
CDP/ANC/AE Eval ________Date Gemcitabine Dose__________Date__________
CDP/ANC/AE Eval ________Date Gemcitabine Dose__________Date__________
ARM 2 - Erlotinib Start Date/Dose_______________
C#2
Days 1, 8, 15
H+P____________Date PS_______ SGOT,Bili,creat.,NA, K, Cl, CO2BUN, Gluc______
CDP/ANC/AE Eval ________Date Gemcitabine Dose__________Date__________
CDP/ANC/AE Eval ________Date Gemcitabine Dose__________Date__________
CDP/ANC/AE Eval ________Date Gemcitabine Dose__________Date__________
ARM 2 – Erlotinib Dose______________
C#3
Days 1, 8, 15
H+P____________Date PS_______ SGOT,Bili,creat.,NA, K, Cl, CO2BUN, Gluc______
CDP/ANC/AE Eval ________Date Gemcitabine Dose__________Date__________
CDP/ANC/AE Eval ________Date Gemcitabine Dose__________Date__________
CDP/ANC/AE Eval ________Date Gemcitabine Dose__________Date__________
ARM 2 – Erlotinib Dose______________
C#4
Days 1, 8, 15
H+P____________Date PS_______ SGOT,Bili,creat.,NA, K, Cl, CO2BUN, Gluc______
CDP/ANC/AE Eval ________Date Gemcitabine Dose__________Date__________
CDP/ANC/AE Eval ________Date Gemcitabine Dose__________Date__________
CDP/ANC/AE Eval ________Date Gemcitabine Dose__________Date__________
ARM 2 – Erlotinib Dose__________________
2
Community_________________
Pt. Case #__________________
Date of Site Visit_____________
Pt. Initials__________________
1st Randomization Date___________
2nd Randomization Date___________
Treatment Start Date_____________
Group Assignment___________
Consent Date_______________
Version Date_______________
Date of Birth_______________
RTOG 0848
C#5
Days 1, 8, 15
H+P____________Date PS_______ SGOT,Bili,creat.,NA, K, Cl, CO2BUN, Gluc______
CDP/ANC/AE Eval ________Date Gemcitabine Dose__________Date__________
CDP/ANC/AE Eval ________Date Gemcitabine Dose__________Date__________
CDP/ANC/AE Eval ________Date Gemcitabine Dose__________Date__________
ARM 2 – Erlotinib Dose______________
Within 3 wks after Completion of 5th Cycle of Chemo Date_____________
H+P________ PS___________ CT/MRI Abd+Pelvis______ Chest CT/CXR_______
CDP/ANC________ SGOT,Bili,creat.,NA, K, Cl, CO2, BUN, Gluc______
AE Eval ________
Pts. Must start 5th cycle of chemo to be eligible for the 2nd randomization. 2nd step
registration must be completed for patients with progressive disease after Arm 1 or Arm
2 tx is complete; however, these patients will not be randomized to further treatment.
Progressive Disease
YES_________→Off Tx
NO_________→2nd Randomization
2nd Randomiation Date_______________ Arm 3__________ Arm 4__________
Erlotinib and Capecitabine Provided
Randomization to Arm 3= 1 Cycle identical to chemotherapy in Arm 1 and 2 (Gem or
Gem+erlotinib)
C#1 Days 1, 8, 15 – Weekly PE/ WT/ Vitals/PS
CDP/ANC/AE Eval________Date Gemcitabine Dose__________Date__________
CDP/ANC/AE Eval ________Date Gemcitabine Dose__________Date__________
CDP/ANC/AE Eval ________Date Gemcitabine Dose__________Date__________
ARM 2 - Erlotinib Date/ Dose_______________
Randomization to Arm 4= 1 Cycle identical to chemotherapy in Arm 1 and 2 (Gem or
Gem+erlotinib)→ Follow w/ RT w/in 21 days after last dose chemo + Either 5 FU
250mg/m2/day, 7 days per week by continuous IV infusion OR Capecitabine 825mg/m2
PO BID M-F. Both start on day 1 of RT for 51/2 weeks or until RT Completed
Days 1, 8, 15 – Weekly PE/ WT/ Vitals/PS
CDP/ANC/AE Eval________Date Gemcitabine Dose__________Date__________
CDP/ANC/AE Eval ________Date Gemcitabine Dose__________Date__________
CDP/ANC/AE Eval ________Date Gemcitabine Dose__________Date__________
ARM 2 - Erlotinib Date/Dose_______________
C#1
RT Start Date_______________
5FU Infusion START Date/Dose_________________ N/A
Capecitabine START Date/Dose________________ N/A
3
End Date/Total Dose______
End Date/Total Dose______
Community_________________
Pt. Case #__________________
Date of Site Visit_____________
Pt. Initials__________________
1st Randomization Date___________
2nd Randomization Date___________
Treatment Start Date_____________
Group Assignment___________
Consent Date_______________
Version Date_______________
Date of Birth_______________
RTOG 0848
Follow-Up Arms 1+2
Every 6 months for 2 years then annually
Follow-up ARMS 3+4
Every 3 months x 2 years, then every 6 months x 3 years then annually
4