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Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer

NCT01302834 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 987

Last updated 2026-01-12

Study results available
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Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. 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 cetuximab, 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 radiation therapy is more effective with cisplatin or cetuximab in treating oropharyngeal cancer.

PURPOSE: This phase III trial is studying radiation therapy with cisplatin or cetuximab to see how well it works in treating patients with oropharyngeal cancer.

Conditions

Interventions

BIOLOGICAL

cetuximab

400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks

DRUG

cisplatin

100 mg/m2 IV on days 1 and 22 of IMRT

RADIATION

IMRT

35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

Sponsors & Collaborators

  • Radiation Therapy Oncology Group

    lead NETWORK

  • National Cancer Institute (NCI)

    collaborator NIH

  • NRG Oncology

    collaborator OTHER

Principal Investigators

  • Andy M. Trotti, MD · H. Lee Moffitt Cancer Center and Research Institute

  • Maura Gillison, MD, PhD · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2018-07-12
Completion
2025-09-04

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01302834 on ClinicalTrials.gov