Gemcitabine With or Without Combination Chemotherapy and Radiation Therapy in Treating Patients With Nonmetastatic Pancreatic Cancer That Cannot Be Removed By Surgery
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: liposomal cisplatin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| 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 |
| Estimated Enrollment: | 190 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00416507 History of Changes |
| Other Study ID Numbers: | CDR0000453847, FFCD-2000-01, EU-20542, FFCD-SFRO-2000-01 |
| Study First Received: | December 27, 2006 |
| Last Updated: | January 22, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the pancreas stage III pancreatic cancer stage II pancreatic cancer |
Additional relevant MeSH terms:
|
Adenocarcinoma Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Cisplatin |
Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Antiviral Agents Anti-Infective Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013