CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 69 enrolled
Drug / intervention
cisplatin +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00608205
NCT00608205Phase 3Completed

A Phase III Randomized Trial Comparing Single Agent Cisplatin With the Combination of 5-Fluorouracil and Cisplatin, Concurrent With Radiation Therapy in Stage III and IV Squamous Cell Head and Neck Cancer

Case Comprehensive Cancer Center·interventional·Posted Feb 6, 2008·Updated Aug 6, 2020

In Brief

A Phase 3 clinical trial evaluating cisplatin, fluorouracil, and 1 other intervention for Head and Neck Cancer. Completed, enrolled 69 participants across 2 sites.

Detailed Summary

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cisplatin and fluorouracil may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without fluorouracil in treating patients with head and neck cancer. PURPOSE: This randomized phase III trial is studying radiation therapy and cisplatin to compare how well they work with or without fluorouracil in treating patients with stage III or stage IV head and neck cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 6, 2008
Enrollment StartJan 1, 2008
Primary CompletionSep 1, 2012
Study CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 18.4 years ago

Interventions

cisplatindrug

Given IV

fluorouracildrug

Given IV

radiation therapyradiation

Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks