Gemcitabine With or Without Combination Chemotherapy and Radiation Therapy in Treating Patients With Nonmetastatic Pancreatic Cancer That Cannot Be Removed By Surgery
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
fluorouracil
gemcitabine hydrochloride
liposomal cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, stage III pancreatic cancer, stage II pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas
- No neuroendocrine or other histologies
- No extra-abdominal metastases
No hepatic or peritoneal metastases by celioscopy
- Peritoneal carcinomatous (cytology positive by peritoneal lavage) may be allowed
Nonresectable disease meeting ≥ 1 of the following criteria:
- Arterial invasion
- Mesenteric-portal vein invasion > 15 mm and or less than hemicircumference
- Satellite adenopathies encompassed in the radiation field
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Bilirubin < 1.75 mg/dL
- Creatinine < 1.5 mg/dL
- WBC > 1,500/mm³
- Platelet count > 100,000/mm³
- No major organ disorder, including cardiac or coronary insufficiency
- Prothrombin time > 80%
- No psychiatric or social condition that would preclude study therapy
- No other malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No contraindications to radiotherapy or chemotherapy
- No intractable pancreatic pain not relieved by morphine and/or analgesic radiotherapy
PRIOR CONCURRENT THERAPY:
- No prior adjuvant or palliative chemotherapy or radiotherapy
- Prior surgical diversion of the biliary and/or digestive tract allowed
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00416507
First Posted
December 27, 2006
Last Updated
May 27, 2016
Sponsor
Federation Francophone de Cancerologie Digestive
1. Study Identification
Unique Protocol Identification Number
NCT00416507
Brief Title
Gemcitabine With or Without Combination Chemotherapy and Radiation Therapy in Treating Patients With Nonmetastatic Pancreatic Cancer That Cannot Be Removed By Surgery
Official Title
Non Resectable But Non Metastatic Adenocarcinoma of the Exocrine Pancreas Non Resecables. Randomised Phase III: Initial Radiochimiotherapy (5-FU, Cisplatine, 60 GY Radiotherapy) Followed by Gemcitabine Versus Gemcitabine Alone
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
March 2000 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federation Francophone de Cancerologie Digestive
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, fluorouracil, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells. It is not yet known which treatment regimen is more effective for pancreatic cancer.
PURPOSE: This randomized phase III trial is studying gemcitabine, fluorouracil, cisplatin, and radiation therapy to see how well they work compared to gemcitabine alone in treating patients with nonmetastatic pancreatic cancer that cannot be removed by surgery.
Detailed Description
OBJECTIVES:
Primary
Compare the overall survival of patients with nonresectable, nonmetastatic adenocarcinoma of the pancreas treated with gemcitabine hydrochloride with vs without fluorouracil, cisplatin, and radiotherapy followed by gemcitabine hydrochloride.
Secondary
Compare the toxicities of these regimens in these patients.
Compare the objective response (complete, partial, or stable) in patients treated with these regimens.
Compare the clinical benefit, in terms of general condition and weight maintenance in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to WHO performance status (0 or 1 vs 2), initial treatment (laparotomy with or without bilio-digestive diversion) (yes vs no), and peritoneal cytology (positive vs negative). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive cisplatin IV over 15 minutes on days 1-5 and 29-33 and fluorouracil IV continuously on days 1-40. Patients also undergo radiotherapy daily, 5 days a week, for 6 weeks.
Arm II: Patients receive gemcitabine hydrochloride IV over 15 minutes on day 1. Treatment repeats every 7 days for 7 weeks.
Beginning in week 11 of arm I or week 9 of arm II, patients receive gemcitabine hydrochloride IV over 15 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed periodically.
PROJECTED ACCRUAL: A total of 190 patients will be accrued for this trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
adenocarcinoma of the pancreas, stage III pancreatic cancer, stage II pancreatic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
190 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
liposomal cisplatin
10. Eligibility
Sex
All
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the pancreas
No neuroendocrine or other histologies
No extra-abdominal metastases
No hepatic or peritoneal metastases by celioscopy
Peritoneal carcinomatous (cytology positive by peritoneal lavage) may be allowed
Nonresectable disease meeting ≥ 1 of the following criteria:
Arterial invasion
Mesenteric-portal vein invasion > 15 mm and or less than hemicircumference
Satellite adenopathies encompassed in the radiation field
PATIENT CHARACTERISTICS:
WHO performance status 0-2
Bilirubin < 1.75 mg/dL
Creatinine < 1.5 mg/dL
WBC > 1,500/mm³
Platelet count > 100,000/mm³
No major organ disorder, including cardiac or coronary insufficiency
Prothrombin time > 80%
No psychiatric or social condition that would preclude study therapy
No other malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
No contraindications to radiotherapy or chemotherapy
No intractable pancreatic pain not relieved by morphine and/or analgesic radiotherapy
PRIOR CONCURRENT THERAPY:
No prior adjuvant or palliative chemotherapy or radiotherapy
Prior surgical diversion of the biliary and/or digestive tract allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francoise Mornex, MD, PhD
Organizational Affiliation
Centre Hospitalier Lyon Sud
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
18467316
Citation
Chauffert B, Mornex F, Bonnetain F, Rougier P, Mariette C, Bouche O, Bosset JF, Aparicio T, Mineur L, Azzedine A, Hammel P, Butel J, Stremsdoerfer N, Maingon P, Bedenne L. Phase III trial comparing intensive induction chemoradiotherapy (60 Gy, infusional 5-FU and intermittent cisplatin) followed by maintenance gemcitabine with gemcitabine alone for locally advanced unresectable pancreatic cancer. Definitive results of the 2000-01 FFCD/SFRO study. Ann Oncol. 2008 Sep;19(9):1592-9. doi: 10.1093/annonc/mdn281. Epub 2008 May 7.
Results Reference
result
Citation
Mornex F, Chauffert B, Bonnetain F, et al.: Definitive results of the French FFCD-SFRO 2000-01 study: phase III trial comparing chemoradiotherapy (cisplatin and infusional 5-FU) followed by gemcitabine vs. gemcitabine alone in patients with locally advanced non metastatic pancreatic cancer. [Abstract] Int J Radiat Oncol Biol Phys 69 (3): A-135, S77, 2007.
Results Reference
result
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Gemcitabine With or Without Combination Chemotherapy and Radiation Therapy in Treating Patients With Nonmetastatic Pancreatic Cancer That Cannot Be Removed By Surgery
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