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Reduced-Dose Intensity-Modulated Radiation Therapy With or Without Cisplatin in Treating Patients With Advanced Oropharyngeal Cancer

NCT02254278 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2026-05-22

Study results available
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Summary

This randomized phase II trial studies the side effects and how well modestly reduced-dose intensity-modulated radiation therapy (IMRT) with or without cisplatin works in treating patients with oropharyngeal cancer that has spread to other places in the body (advanced). Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether IMRT is more effective with or without cisplatin in treating patients with oropharyngeal cancer.

Conditions

  • Stage III Oropharyngeal Squamous Cell Carcinoma
  • Stage IVA Oropharyngeal Squamous Cell Carcinoma
  • Stage IVB Oropharyngeal Squamous Cell Carcinoma
  • Stage IVC Oropharyngeal Squamous Cell Carcinoma
  • Tongue Carcinoma

Interventions

DRUG

Cisplatin

40 mg/m2 IV (intravenously) weekly for 6 weeks

RADIATION

IMRT 6 weeks

Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy

RADIATION

IMRT 5 weeks

Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • NRG Oncology

    lead OTHER

Principal Investigators

  • Sue Yom · NRG Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2019-06-10
Completion
2025-09-04

Countries

  • United States
  • Canada
  • Ireland
  • Saudi Arabia

Study Locations

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Entities

Drugs
Companies

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 NCT02254278 on ClinicalTrials.gov