At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 74 enrolled

Drug / intervention

Gemcitabine +1 moredrug

Likely dose

Gemcitabine 1000 mg/m² intravenously once per week for 6 weeks (induction phase) followed by 1000 mg/m² once per week for 3 weeks (consolidation phase); or gemcitabine 600 mg/m² intravenously once per week for 6 weeks concurrent with radiation therapyAI-extracted

Key inclusion· 6

✓Histologically or cytologically confirmed adenocarcinoma of the pancreas that is locally advanced or regional and unresectable
✓Measurable or non-measurable disease on CT or MRI within 4 weeks prior to randomization
✓Age 18 or older
✓ECOG Performance Status 0-1

Key exclusion· 12

✕Candidate for surgical resection (resectable disease)
✕Stage M1 (metastatic) disease
✕Non-adenocarcinoma histology including small cell, mucinous cystadenocarcinoma, islet cell, or papillary cystic types
✕Pregnant or nursing

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00057876

NCT00057876Phase 3Completed

Compare CT.gov

A Randomized Phase III Study Of Gemcitabine In Combination With Radiation Therapy Versus Gemcitabine Alone In Patients With Localized, Unresectable Pancreatic Cancer

Eastern Cooperative Oncology Group·interventional·Posted Apr 9, 2003·Updated Jul 5, 2023

In Brief

A Phase 3 clinical trial evaluating Gemcitabine and radiation therapy for Pancreatic Cancer. Completed, enrolled 74 participants across 229 sites in 2 countries.

Detailed Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether gemcitabine is more effective with or without radiation therapy in treating pancreatic cancer. PURPOSE: Randomized phase III trial to study the effectiveness of gemcitabine with or without radiation therapy in treating patients who have locally advanced, unresectable pancreatic cancer.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPancreatic Cancer

CountriesSouth Africa, United States

CollaboratorsNational Cancer Institute (NCI), Radiation Therapy Oncology Group

Timeline

Phase 3CompletedFinished

2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

First PostedApr 2003

Enrollment StartAug 2003

Primary CompletionMay 2009

TodayJul 2026

First PostedApr 9, 2003

Enrollment StartAug 29, 2003

Primary CompletionMay 1, 2009

TodayJul 2, 2026

Enrollment to primary: 5.7 yearsPosted 23.2 years ago

Interventions

Gemcitabinedrug

Induction: Patients receive the first cycle of gemcitabine 1000 mg/m\^2 intravenously once per week for 6 weeks followed by 1 week rest. Consolidation: Following the week of rest, treatment resume with gemcitabine 1000 mg/m\^2 administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles.

radiation therapyradiation

Induction: Patients receive gemcitabine 600 mg/m\^2 intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose is given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction is 180 cGy prescribed to the isocenter. The total dose of radiation is 5040 cGy given in 28 fractions over 5 1/2 weeks. Consolidation: Additional cycles of gemcitabine begin approximately 4 weeks after completion of radiation therapy.