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

Study ID
STU 102012-041

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

Contact
Kristy Carter
214-648-3626
kristy.carter@utsouthwestern.edu

Principal Investigator
Baran Sumer

Summary

This is a randomized, two-armed trial. Subjects become eligible for entry into the study when they meet each of the inclusion criteria. Subjects with p16 positive orogpharnygeal tumors meet eligibility only after their surgery and pathology specimen analysis. Steps to enrollment include:

1. Confirm subject eligibility by sending required information to Washington university (name and contact information; Pi, registering MD and institution name; subject race, sex and DoB; subject's initials; approved protocol version date; copy of signed consent; planned date of sample shipment; completed eligibility checklist; copy of source doc confirming subject eligibility; access information for subject randomization website).
2. Register subject in the Siteman Cancer Center database.
3. assignment of unique patient iD number (uPn).
4. Patient is randomized 1:1 to study arm - arm 1 concurrent chemoradiation or arm 2 radiotherapy. assignments will be balanced within blocks of random size. in arm 1 subjects will receive chemotherapy and radiation therapy. arm 2 will receive radiation therapy only.

The study primary endpoints are disease-free survival and loco-regional control. Disease-free survival (DFS) is defined as the time from surgery to the date of death or recurrence of disease. Locoregional failure will include local recurrence at the primary oropharyngeal site and regional recurrence in the neck nodal basins. Local recurrence will be defined as biopsy proven tumor in the immediate vicinity (i.e. within 2 cm) of the original primary. Regional recurrence will be defined as development of histologically proved metastases in cervical lymph nodes.

The secondary oncological endpoints will be distant metastasis rates and disease specific survival. after completion of treatment, biopsy or imaging-detected recurrent disease at sites away from the original primary and cervical zone will constitute a distant metastasis. Disease-specific survival (DSS) is defined as the time from surgery to death from recurrent oropharyngeal cancer or treatment-related death. The cumulative incidence of complications/ acute toxicity, and assessment of outcomes of function and quality of life will be the other secondary endpoints.

Participant Eligibility

1. Patient must have histologically confirmed p16 positive squamous cell carcinoma of the oropharynx (OPSCC). (See Section 4.0.)

2. Patient must have undergone transoral resection of their T1-4a oropharynx primary to a negative margin, and a neck dissection(s).

3. Patient[Single Quote]s disease must be pathological N-stage positive.

4. Patient[Single Quote]s disease must show extracapsular spread (ECS) in their nodal metastasis. (See Section 4.0.)

5. Patients with synchronous primaries are included.

6. Patients with unknown primaries are included if the diagnosis of a primary site in the oropharynx is made during the surgery.

7. Patients with recent excisional node biopsies/neck dissections are included if material is evaluable for extracapsular spread.

8. Patient must be > 21 years of age.

9. ECOG performance status < 2 (Karnofsky >60%; see Appendix A).

10. 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

11. Patient (or legally authorized representative) must be able to understand and willing to sign a written informed consent document.