Post Operative Adjuvant Therapy De-intensification Trial for Human Papillomavirus-related, p16+ Oropharynx Cancer
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: III What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Scottsdale/Phoenix, Arizona: 12-010177
NCT ID: NCT01687413
Sponsor Protocol Number: 201207059
About this study
This randomized 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. After the surgery, patients are randomized to receive either radiation alone, or radiation and weekly cis-platinum during therapy. Patients are then followed for cancer, functional and quality of life outcomes.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
- Patient must have histologically confirmed p16 positive squamous cell carcinoma of the oropharynx (OPSCC).
- Patient must have undergone transoral resection of their T1-4a oropharynx primary to a negative margin, and a neck dissection(s).
- Patient's disease must be pathological N-stage positive.
- Patient's disease must show extracapsular spread (ECS) in their nodal metastasis verified by central pathologist's review.
- Patients with synchronous primaries are included.
- Patients with unknown primaries are included if the diagnosis of a primary site in the oropharynx is made during the surgery.
- Patients with recent excisional node biopsies/neck dissections are included if material is evaluable for extracapsular spread.
- Patient must be ≥ 21 years of age.
- ECOG performance status ≤ 2 (Karnofsky ≥60%).
- Patients must have normal organ and marrow function as defined below:
- leukocytes ≥3,000/mcL
- absolute neutrophil count ≥1,500/mcL
- platelets ≥100,000/mcL
- total bilirubin <1.5 X upper normal institutional limit
- AST(SGOT)/ALT(SGPT) ≤2.5 X institutional upper limit of normal
- creatinine within normal institutional limits OR
- creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Patient (or legally authorized representative) must be able to understand and willing to sign a written informed consent document.
- Patient must not have pathologically N stage negative disease.
- Patient must not have outside nodal tissue from previous neck biopsy/neck dissections in which ECS cannot be confirmed or denied.
- Patient must not have a true unknown primary in which permanent section results are negative for malignancy in completely excised ipsilateral oropharyngeal tissue (palatine and lingual tonsil).
- Patient must not have distant metastatic disease at presentation.
- Patient must not have gross residual and/or microscopic disease present after surgery including re-resection(s), per the operative and pathology report.
- Patient must not have a history of prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers (for example, carcinoma in situ of the oral cavity, larynx, breast or cervix are all permissible) are permitted even if diagnosed and treated < 3 years ago.
- Patient must not have had previous systemic chemotherapy for the study cancer. (Note: prior chemotherapy for a different cancer is allowable).
- Patient must not be receiving any other investigational agents.
- Patient must not have had any prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Patient must not have any life-threatening comorbid illnesses e.g. stroke with major sequelae or myocardial infarction/ unstable angina within the preceding 3 months or psychiatric illness/social situations that would limit compliance with study requirements.
- Patient must not be pregnant or breastfeeding. If a woman of childbearing potential, patient must agree to use medically acceptable forms of contraception.
Both men and women and members of all races and ethnic groups are eligible for this trial.
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Michael Hinni, M.D.
Open for enrollment
Cancer Center Clinical Trials Referral Office