Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Gemcitabine and Radiation Therapy Compared With Gemcitabine Alone in Treating Patients Who Have Undergone Surgery for Pancreatic Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III, Phase II	Treatment	Closed	18 and over	Other	EORTC-40013 EORTC-22012, FFCD-0304, NCT00064207, EU-20540

Objectives

Phase II:

1. Determine the feasibility of gemcitabine followed by chemoradiotherapy with gemcitabine vs gemcitabine alone after prior curative resection in patients with pancreatic head adenocarcinoma.
2. Compare the tolerability of these regimens, in terms of acute and late toxicity, in these patients.

Phase III:

1. Compare the disease-free and overall survival of patients treated with these regimens .
2. Compare the quality of life of patients treated with these regimens.
3. Compare the toxicity of these regimens in these patients.
4. Determine the sites of recurrence in patients treated with these regimens.

Entry 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

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

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/mm³
• Platelet count greater than 150,000/mm³
• 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

Expected Enrollment

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

Outcomes

Feasibility of full completion of treatment as measured by the number of patients completing treatment 1 month after treatment in phase II
Tolerability in terms of acute toxicity as measured by NCI-CTC v2.0 1 month after completion of treatment in phase II
Tolerability in terms of late toxicity as measured by EORTC and RTOG 1 month after completion of treatment in phase II
Overall survival as measured by Logrank every 3 months in years 1-2, and every 6 months thereafter in phase III

Disease-free survival as measured by Logrank every 3 months in years 1-2, and every 6 months thereafter
Acute toxicity as measured by NCI-CTC v2.0 every 3 months in years 1-2, and every 6 months thereafter
Late toxicity as measured by EORTC and RTOG every 3 months in years1-2, and every 6 months thereafter
Quality of life as measured by Quality of Life Questionnaire Core 30 (QLQ-C30) v3.0 and EORTC QLQ PAN-26 every 3 months in years 1-2 and every 6 months thereafter

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.

Van Laethem JL, Mornex F, Azria D, et al.: Adjuvant gemcitabine alone versus gemcitabine-based chemoradiation after curative resection for pancreatic cancer: updated results of a randomized EORTC/FFCD/GERCOR phase II study (40013-22012/9203). [Abstract] J Clin Oncol 27 (Suppl 15): A-4527, 2009.

Van Laethem J, Van Cutsem E, Hammel P, et al.: Adjuvant chemotherapy alone versus chemoradiation after curative resection for pancreatic cancer : feasibility results of a randomised EORTC/FFCD/GERCOR phase II/III study (40013/22012/0304). [Abstract] J Clin Oncol 26 (Suppl 15): A-4514, 2008.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Jean-Luc Van Laethem, MD, PhD, Protocol chair		Ph: 32-2-555-3712 Email: jvlaethe@ulb.ac.be
Volker Budach, MD, PhD, Protocol co-chair		Ph: 49-30-450-52-7021 Email: volker.budach@charite.de

Federation Francophone de Cancerologie Digestive

P. Hammel, MD, PhD, Protocol chair		Ph: 33-14-087-5653 Email: pascal.hammel@bju.ap-hop-paris.fr

Registry Information
Official Title		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
Trial Start Date		2003-05-22
Registered in ClinicalTrials.gov		NCT00064207
Date Submitted to PDQ		2003-05-27
Information Last Verified		2006-11-19

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