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Randomized Phase II/III Study Comparing Gemcitabine Followed by Gemcitabine Plus Concomitant Radiation (50.4 Gy) Versus Control After Curative Pancreaticoduodenectomy for Pancreatic Head Cancer


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

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Trial Information

Randomized Phase II/III Study Comparing Gemcitabine Followed by Gemcitabine Plus Concomitant Radiation (50.4 Gy) Versus Control After Curative Pancreaticoduodenectomy for Pancreatic Head Cancer


OBJECTIVES:

Phase II:

- Determine the feasibility of gemcitabine followed by chemoradiotherapy with gemcitabine
vs gemcitabine alone after prior curative resection in patients with pancreatic head
adenocarcinoma.

- Compare the tolerability of these regimens, in terms of acute and late toxicity, in
these patients.

Phase III:

- Compare the disease-free and overall survival of patients treated with these regimens .

- Compare the quality of life of patients treated with these regimens.

- Compare the toxicity of these regimens in these patients.

- Determine the sites of recurrence in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
ECOG/WHO performance status (0-1 vs 2), participating center, and N stage (N0 vs N1 vs NX).
Patients are randomized to 1 of 2 treatment arms.

- Arm I: Within 8 weeks after prior surgical resection, patients receive gemcitabine IV
over 30 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for 2 courses.

Patients then receive additional gemcitabine IV over 30 minutes on days 57, 64, 71, 78, 85,
and 92. Beginning on day 57, patients also undergo radiotherapy once daily, 5 days a week,
for 6 weeks. Treatment continues in the absence of disease progression or unacceptable
toxicity.

- Arm II: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment
repeats every 4 weeks for 4 courses.

Quality of life (QOL) is assessed in both arms, according to the following schedules:

- Arm I: QOL is assessed at baseline; at 3 weeks after the beginning of
chemoradiotherapy; after the completion of chemoradiotherapy; every 3 months for 2
years; and then every 6 months for 1 year.

- Arm II: QOL is assessed at baseline; at 12 weeks; at 16 weeks; every 3 months for 2
years; and then every 6 months for 1 year.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 538 patients (269 per treatment arm) will be accrued for this
study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed pancreatic head adenocarcinoma

- Prior pancreaticoduodenectomy required

- Documented histological examination of surgical margins (R0), including
retroperitoneal margin

- Performed within the past 8 weeks

- Any number of lymph nodes (less than 10 OR 10 or more) allowed

- No periampullary cancer

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2 OR

- WHO 0-2

Life expectancy

- Not specified

Hematopoietic

- WBC greater than 3,500/mm^3

- Platelet count greater than 150,000/mm^3

- Hemoglobin greater than 9.0 g/dL

Hepatic

- Bilirubin less than 1.5 times normal

- AST and ALT less than 3.0 times normal

Renal

- Creatinine less than 1.2 mg/dL

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in
situ of the cervix

- No psychological, familial, sociological, or geographical condition that would
preclude study compliance and follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent immunotherapy

Chemotherapy

- No prior chemotherapy

- No other concurrent chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy

Surgery

- See Disease Characteristics

- Recovered from prior surgery

Other

- No other concurrent anticancer agents

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Feasibility of full completion of treatment as measured by the number of patients completing treatment 1 month after treatment in phase II

Safety Issue:

No

Principal Investigator

Jean-Luc Van Laethem, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Hopital Universitaire Erasme

Authority:

United States: Federal Government

Study ID:

EORTC-40013-22012

NCT ID:

NCT00064207

Start Date:

May 2003

Completion Date:

Related Keywords:

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

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