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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


Phase 3
N/A
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Francoise Mornex, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre Hospitalier Lyon Sud

Authority:

United States: Federal Government

Study ID:

CDR0000453847

NCT ID:

NCT00416507

Start Date:

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • adenocarcinoma of the pancreas
  • stage III pancreatic cancer
  • stage II pancreatic cancer
  • Adenocarcinoma
  • Pancreatic Neoplasms

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