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Adjuvant De-escalation, Extracapsular Spread, P16+, Transoral (A.D.E.P.T.) Trial for Oropharynx Malignancy

Phase 3
21 Years
Open (Enrolling)
Oropharyngeal Neoplasms

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Trial Information

Adjuvant De-escalation, Extracapsular Spread, P16+, Transoral (A.D.E.P.T.) Trial for Oropharynx Malignancy

Inclusion 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.

Exclusion Criteria:

- 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival (DFS)

Outcome Description:

Survival probability will be estimated by Kaplan-Meier analysis and survival curves for patients with adjuvant radiotherapy w and w/o chemotherapy will be compared by use of log-rank statistic.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Bruce Haughey, MBChB

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

January 2013

Completion Date:

October 2021

Related Keywords:

  • Oropharyngeal Neoplasms
  • Neoplasms
  • Oropharyngeal Neoplasms



Washington University School of MedicineSaint Louis, Missouri  63110
Ut Southwestern Medical CenterDallas, Texas  75390
Mayo Clinic-RochesterRochester, Minnesota  55905
University of North Carolina School of MedicineChapel Hill, North Carolina  27599
Mayo Clinic-Scottsdale/PhoenixScottsdale, Arizona  85259