Spots Global Cancer Trial Database for Post Operative Adjuvant Therapy De-intensification Trial for Human Papillomavirus-related, p16+ Oropharynx Cancer
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Trial Identification
Brief Title: Post Operative Adjuvant Therapy De-intensification Trial for Human Papillomavirus-related, p16+ Oropharynx Cancer
Official Title: Adjuvant De-escalation, Extracapsular Spread, P16+, Transoral (ADEPT) Trial for Oropharynx Malignancy
Study ID: NCT01687413
Conditions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Scottsdale, Scottsdale, Arizona, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Contact Details
Name: Jason Rich, MD
Affiliation: Washington University School of Medicine
Role: PRINCIPAL_INVESTIGATOR
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