CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 320 enrolled
Drug / intervention
panitumumab +4 morebiological
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/NCT00820248
NCT00820248Phase 3Completed

A Phase III Study of Standard Fractionation Radiotherapy With Concurrent High-Dose Cisplatin Versus Accelerated Fractionation Radiotherapy With Panitumumab in Patients With Locally Advanced Stage III and IV Squamous Cell Carcinoma of the Head and Neck

NCIC Clinical Trials Group·interventional·Posted Jan 12, 2009·Updated Aug 22, 2023

In Brief

A Phase 3 clinical trial evaluating panitumumab, cisplatin, and 3 other interventions for Head and Neck Cancer. Completed, enrolled 320 participants across 19 sites.

Detailed Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving standard radiation therapy together with high-dose cisplatin is more effective than giving higher-dose radiation therapy together with panitumumab in treating patients with locally advanced head and neck cancer. PURPOSE: This randomized phase III trial is comparing two radiation therapy regimens to see how well they work when given together with cisplatin or panitumumab in treating patients with locally advanced stage III or stage IV head and neck cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 12, 2009
Enrollment StartDec 30, 2008
Primary CompletionMay 16, 2015
Study CompletionFeb 17, 2017
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 17.5 years ago

Interventions

panitumumabbiological

Given IV

cisplatindrug

Given IV

3-dimensional conformal radiation therapyradiation

Patients undergo radiotherapy

accelerated radiation therapyradiation

Patients undergo accelerated fractionation radiotherapy

intensity-modulated radiation therapyradiation

Patients undergo radiotherapy