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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. |
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| Detailed Description | OBJECTIVES: Phase II:
Phase III:
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.
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.
Quality of life (QOL) is assessed in both arms, according to the following schedules:
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. |
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| 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 ] |
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| 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 ] |
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| Condition † | Pancreatic Cancer | ||||||||||||
| Intervention † | Drug: gemcitabine hydrochloride Procedure: adjuvant therapy Procedure: radiation therapy |
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| MEDLINE PMIDs | |||||||||||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||||||||||
| Recruitment Status † | Active, not recruiting | ||||||||||||
| Enrollment † | 538 | ||||||||||||
| Start Date † | May 2003 | ||||||||||||
| Completion Date | |||||||||||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Gender | Both | ||||||||||||
| Ages | 18 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| 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 † |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||||||
| Verification Date | November 2006 | ||||||||||||
| First Received Date † | July 8, 2003 | ||||||||||||
| Last Updated Date | June 26, 2008 | ||||||||||||