www.rtog.org 1 RTOG 9704: A Phase III Study of RTOG 9704: A Phase III Study of Adjuvant Pre and Post Adjuvant Pre and Post Chemoradiation 5-FU vs. Chemoradiation 5-FU vs. Gemcitabine for Resected Gemcitabine for Resected Pancreatic Adenocarcinoma Pancreatic Adenocarcinoma William F. Regine, K.A. Winter, R. William F. Regine, K.A. Winter, R. Abrams, Abrams, H. Safran, J.P. Hoffman, A. Konski, A.B. H. Safran, J.P. Hoffman, A. Konski, A.B. Benson, Benson, J.S. Macdonald, C.G. Willett, Tyvin A. J.S. Macdonald, C.G. Willett, Tyvin A. Rich Rich A U.S. GI INTERGROUP TRIAL A U.S. GI INTERGROUP TRIAL
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William F. Regine, K.A. Winter, R. Abrams, H. Safran, J.P. Hoffman, A. Konski, A.B. Benson,
RTOG 9704: A Phase III Study of Adjuvant Pre and Post Chemoradiation 5-FU vs. Gemcitabine for Resected Pancreatic Adenocarcinoma. William F. Regine, K.A. Winter, R. Abrams, H. Safran, J.P. Hoffman, A. Konski, A.B. Benson, J.S. Macdonald, C.G. Willett, Tyvin A. Rich. - PowerPoint PPT Presentation
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www.rtog.org 1
RTOG 9704: A Phase III Study of Adjuvant RTOG 9704: A Phase III Study of Adjuvant
Pre and Post Chemoradiation 5-FU vs. Pre and Post Chemoradiation 5-FU vs.
Gemcitabine for Resected Pancreatic Gemcitabine for Resected Pancreatic
AdenocarcinomaAdenocarcinoma
William F. Regine, K.A. Winter, R. Abrams, William F. Regine, K.A. Winter, R. Abrams, H. Safran, J.P. Hoffman, A. Konski, A.B. Benson, H. Safran, J.P. Hoffman, A. Konski, A.B. Benson,
J.S. Macdonald, C.G. Willett, Tyvin A. RichJ.S. Macdonald, C.G. Willett, Tyvin A. Rich
A U.S. GI INTERGROUP TRIALA U.S. GI INTERGROUP TRIAL
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Gemcitabine Single-Agent First-Line: Results of a Randomized Trial*
Gemcitabine Single-Agent First-Line: Results of a Randomized Trial*
*In Patients with locally advanced/metastatic Pancreatic Ca*In Patients with locally advanced/metastatic Pancreatic Ca
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Main ObjectiveMain Objective
RTOG 9704 / US Intergroup Phase III Adjuvant StudyRTOG 9704 / US Intergroup Phase III Adjuvant Study
• To evaluate the impact of the addition of To evaluate the impact of the addition of
Gemcitabine to 5–FU Chemoradiation (CRT) Gemcitabine to 5–FU Chemoradiation (CRT)
in the postop in the postop adjuvantadjuvant treatment of patients treatment of patients
with pancreatic adenocarcinoma (adenoCa)with pancreatic adenocarcinoma (adenoCa)
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RTOG 9704 / US INTERGROUP Phase III Study RTOG 9704 / US INTERGROUP Phase III Study (Schema)(Schema) Resected AdenoCa of the PancreasResected AdenoCa of the Pancreas
Arm 1Arm 1: 5–FU, 250mg/m: 5–FU, 250mg/m22/d, Continuous Infusion (CI) x 3 weeks/d, Continuous Infusion (CI) x 3 weeks Arm 2:Arm 2: Gemcitabine, 1000mg/m Gemcitabine, 1000mg/m22, weekly x 3, weekly x 3
CRTCRT (Initiated 1 - 2 wks after pre – CRT Chemo): (Initiated 1 - 2 wks after pre – CRT Chemo):
Arm 1 & 2Arm 1 & 2:: 50.4 Gy/1.8Gy/Fx + 5–FU, 250mg/m 50.4 Gy/1.8Gy/Fx + 5–FU, 250mg/m22/d, CI x 5 1/2 wks/d, CI x 5 1/2 wks
POST – CRT CHEMOTHERAPYPOST – CRT CHEMOTHERAPY (Initiated 3 – 5 wks after CRT): (Initiated 3 – 5 wks after CRT):
Arm 1Arm 1:: 3 mos of CI 5–FU [(4 wks on + 2 wks off) x 2] 3 mos of CI 5–FU [(4 wks on + 2 wks off) x 2] Arm 2Arm 2:: 3 mos of Gemcitabine [(3 wks on + 1 wk off) x 3] 3 mos of Gemcitabine [(3 wks on + 1 wk off) x 3]
TreatmentTreatment
RTOG 9704 / US Intergroup Phase III Adjuvant StudyRTOG 9704 / US Intergroup Phase III Adjuvant Study
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• Localized AdenoCa of the pancreas
• S/P gross total/potentially curative resection
• AJCC 5th Ed. Stages T1-4, N0-1
• Protocol Rx to begin w/i 3-8 wks of surgery
• KPS > 60; Age > 18
• Adequate nutrition ( > 1500 calories/day)
Entry CriteriaEntry Criteria
RTOG 9704 / US Intergroup Phase III Adjuvant StudyRTOG 9704 / US Intergroup Phase III Adjuvant Study
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RTOG 9704 / US Intergroup Phase III Adjuvant StudyRTOG 9704 / US Intergroup Phase III Adjuvant Study
• CA19-9 drawn for central submission
• M1 or NX Disease ineligible
• Prior RT/ChemoRx ineligible
• Tumor Types excluded:
Non-AdenoCa, AdenoSquamCa,
CystAdenoCa, Duodenal, Distal Bile Duct,
Ampullary Cas
Entry CriteriaEntry Criteria
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Entry CriteriaEntry Criteria
Prospective Quality Assurance of
Radiation Therapy Fields Required*
RTOG 9704 / US Intergroup Phase III Adjuvant StudyRTOG 9704 / US Intergroup Phase III Adjuvant Study
*First Phase III Adjuvant Pancreas Trial to Do So*First Phase III Adjuvant Pancreas Trial to Do So
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Study EndpointsStudy Endpoints Primary
• Overall Survival Pts with ‘Pancreatic Head’ tumorsPts with ‘Pancreatic Head’ tumors All PatientsAll Patients
Secondary
• Disease Free Survival
• Toxicity
• Prospectively correlate CA19-9 to outcome
RTOG 9704 US / Intergroup Phase III Adjuvant StudyRTOG 9704 US / Intergroup Phase III Adjuvant Study