NCT00003216

Fluorouracil, Gemcitabine, and Radiation Therapy in Treating Patients With Cancer of the Pancreas

Study Contact:

Study Phase:

PHASE3

Recruitment Status:

COMPLETED

NCT ID:

NCT00003216

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

A Phase III Study of Pre and Post Chemoradiation 5-FU vs. Pre and Post Chemoradiation Gemcitabine for Postoperative Adjuvant Treatment of Resected Pancreatic Adenocarcinoma

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known which treatment regimen is most effective for pancreatic cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil and gemcitabine plus radiation therapy in treating patients with cancer of the pancreas who have undergone surgery.

Eligibility

DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the pancreas

* Stage T1-4, N0-1 (stage I-IVA)
* No M1 or NX staging
* Primary tumor of the pancreas (pancreatic head, neck, uncinate process, or body/tail) and maximum diameter/dimension and tumor status at surgical margin known
* Prior potentially curative gross resection within 3-8 weeks before study
* No non-adenocarcinomas, adenosquamous carcinomas, islet cell carcinomas, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct carcinoma, or ampullary carcinoma
* No recurrent disease
* Post-resection CA-19-9 level required

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 60-100%

Life expectancy:

* Not specified

Hematopoietic:

* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT no greater than 5 times ULN

Renal:

* Creatinine no greater than 1.5 times ULN

Other:

* No significant nausea or vomiting
* No prior malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
* Able to maintain adequate nutrition (at least 1,500 calories/day)

* Feeding tube allowed
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior radiotherapy

Surgery:

* See Disease Characteristics

Disease(s) and\or Condition(s)

Pancreatic Cancer

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: fluorouracil
- Description:
- Arm Group Labels:
- Type: DRUG
- Name: gemcitabine hydrochloride
- Description:
- Arm Group Labels:
- Type: RADIATION
- Name: radiation therapy
- Description:
- Arm Group Labels:

Sponsor

Radiation Therapy Oncology Group