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Post Operative Adjuvant Therapy De-intensification Trial for Human Papillomavirus-related, p16+ Oropharynx Cancer

NCT01687413 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2020-11-25

Study results available
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Summary

This clinical trial studies the intensity of adjuvant ("helper") therapy required in p16 positive oropharynx cancer patients, who have had all known disease removed surgically by a minimally invasive approach, and who have extracapsular spread in their lymph nodes. Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways. After the surgery, receive either radiation alone, or radiation and weekly cis-platinum during therapy. Patients are then followed for cancer, functional and quality of life outcomes.

Conditions

  • Oropharyngeal Neoplasms

Interventions

RADIATION

Intensity-modulated radiation therapy (IMRT)

DRUG

Cisplatin

Sponsors & Collaborators

  • The Foundation for Barnes-Jewish Hospital

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Jason Rich, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-10
Primary Completion
2019-10-18
Completion
2019-10-18
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01687413 on ClinicalTrials.gov