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

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

This study is ongoing, but not recruiting participants.

Study NCT00064207. Last updated on June 26, 2008. Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields

Brief Title ^†

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

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

Brief Summary

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.

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.

Study Phase

Phase II, Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Active Control

Primary Outcome Measure ^†

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 Measure ^†

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 ]

Condition ^†

Pancreatic Cancer

Intervention ^†

Drug: gemcitabine hydrochloride
Procedure: adjuvant therapy
Procedure: radiation therapy

MEDLINE PMIDs

Links

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

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

538

Start Date ^†

May 2003

Completion Date

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Belgium, France, Germany, Israel, Netherlands, Switzerland

Administrative Information Fields

NCT ID ^†

NCT00064207

Organization ID

CDR0000310131

Secondary IDs ^††

EORTC-40013, EORTC-22012, FFCD-0304, EU-20540

Study Sponsor ^†

European Organization for Research and Treatment of Cancer

Collaborators ^††

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:	P. Hammel, MD, PhD	Hopital Beaujon

Information Provided By

National Cancer Institute (NCI)

Verification Date

November 2006

First Received Date ^†

July 8, 2003

Last Updated Date

June 26, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.