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

Sponsor:	European Organization for Research and Treatment of Cancer - EORTC
Collaborator:	Federation Francophone de Cancerologie Digestive
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00064207

Purpose

RATIONALE: Drugs used in chemotherapy such as gemcitabine use 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 these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving gemcitabine together with radiation therapy is more effective than gemcitabine alone following surgery in treating pancreatic cancer.

PURPOSE: This randomized phase II/III trial is studying how well giving gemcitabine together with radiation therapy works and compares it to gemcitabine alone in treating patients who have undergone surgery for pancreatic cancer.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: gemcitabine hydrochloride Procedure: adjuvant therapy Radiation: radiation therapy	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Feasibility of full completion of treatment as measured by the number of patients completing treatment 1 month after treatment in phase II [ Designated as safety issue: No ]
Tolerability in terms of acute toxicity as measured by NCI-CTC v2.0 1 month after completion of treatment in phase II [ Designated as safety issue: Yes ]
Tolerability in terms of late toxicity as measured by EORTC and RTOG 1 month after completion of treatment in phase II [ Designated as safety issue: Yes ]
Overall survival as measured by Logrank every 3 months in years 1-2, and every 6 months thereafter in phase III [ Designated as safety issue: No ]

Secondary Outcome Measures:

Disease-free survival as measured by Logrank every 3 months in years 1-2, and every 6 months thereafter [ Designated as safety issue: No ]
Acute toxicity as measured by NCI-CTC v2.0 every 3 months in years 1-2, and every 6 months thereafter [ Designated as safety issue: Yes ]
Late toxicity as measured by EORTC and RTOG every 3 months in years1-2, and every 6 months thereafter [ Designated as safety issue: Yes ]
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 [ Designated as safety issue: No ]

Estimated Enrollment:	538
Study Start Date:	May 2003

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064207

Show 59 Study Locations

Sponsors and Collaborators

European Organization for Research and Treatment of Cancer - EORTC

Federation Francophone de Cancerologie Digestive

Investigators

Study Chair:	Jean-Luc Van Laethem, MD, PhD	Hopital Universitaire Erasme
Investigator:	Volker G. Budach, MD, PhD	Charite University, Berlin, Germany
Study Chair:	Pascal Hammel, MD, PhD	Hopital Beaujon

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Van Laethem JL, Hammel P, Mornex F, Azria D, Van Tienhoven G, Vergauwe P, Peeters M, Polus M, Praet M, Mauer M, Collette L, Budach V, Lutz M, Van Cutsem E, Haustermans K. Adjuvant Gemcitabine Alone Versus Gemcitabine-Based Chemoradiotherapy After Curative Resection for Pancreatic Cancer: A Randomized EORTC-40013-22012/FFCD-9203/GERCOR Phase II Study. J Clin Oncol. 2010 Sep 13; [Epub ahead of print]

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.

ClinicalTrials.gov Identifier:	NCT00064207 History of Changes
Other Study ID Numbers:	CDR0000310131, EORTC-40013, EORTC-22012, FFCD-0304, EU-20540
Study First Received:	July 8, 2003
Last Updated:	September 22, 2010
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the pancreas
stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer

Additional relevant MeSH terms:

Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on February 12, 2012