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Clinical Trials in Transoral Endoscopic Head and Neck Surgery

ECOG 3311 HPV+ trial (Ferris - PI)

"Phase II Randomized Trial of Transoral Surgical Resection followed by Low-dose or Standard-dose IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer”

This trial has accrued around 52 patients (of planned 377 patients). The distribution into each of the 4 adjuvant therapy arms is approximately that which was predicted

Surgeon-credentialing is required and the process is administered by a 7-person committee of surgeons and clinical trialists who will review 10 OPSCC transoral surgical cases/pathology reports.

Thus far, 50 credentialed surgeons have been accrued for transoral robotic and laser surgery. Accrual for one trial permits accrual on both studies once opened locally.

Transoral eHNS Credentialing Working Group
For ECOG3311

Frequently Asked Questions (FAQ)

Who is eligible to participate?

  • Surgeons with significant experience and clinical volume for transoral resection of T1-2 oropharyngeal carcinoma (OPC) (>20 cases of TORS or TLM).
  • Surgeons who surgeon have performed at least 5-10 transoral resections of OPC in the past 12 months
  • Surgeons working at institutions and hospitals with affiliation with these cooperative groups: NRG/RTOG, ECOG/ACRIN, and/or CCOP. 

What do I need to do to participate? 

1.) Download clinical trial and informed consent documents – involve your local departmental or cancer center coordinator(s) and regulatory staff for trial document submission

ECOG3311:                  
http://bit.ly/ECOG3311_protocol*
http://bit.ly/ECOG3311_consent*
(* behind members-only ECOG firewall)

Contact the Clinical Trials Support Unit (CTSU)
ctsucontact@westat.com for access

2.) Have your Clinical Research Coordinator contact hnsurgcredpanel@jimmy.harvard.edu

3.) Submit pathology report and operative notes for ten (10) OROPHARYNGEAL cases, including at least one tonsil and one tongue-base primary tumor, performed within the last two years (2012-2014)

N.B.: Cases should be SCC, preferably (a minority can be salivary histology) but allshould be oropharyngeal cancer cases with margin assessment in the pathology report.  Either HPV-positive or HPV-negative SCC cases are acceptable, provided that they are from an oropharyngeal site, preferably tongue-base or tonsil. Unknown primary cancer cases are acceptable provided that a primary was found and margins were taken (and were clear).

Drs. Ferris and Holsinger are available at any point in the process regarding case submissions (even prior to uploading) to expedite review and to avoid delays in approval. 

Credentialing is granted based on the surgical modality and each modality requires the requesting surgeon to present 10 cases.  For instance, 10 OPC cases performed by TLM must be presented to request credentials for TLM.  Similarly, ten OPC cases performed by TORS must be presented to request credentials for TORS.  It is possible and encouraged for surgeons capable in both techniques to credential in both TLM and TORS. However, this would require 20 cases total (10 TLM; 10 TORS) to be submitted.

In other words, approval is technology specific.

4.) Submit the Speech Pathology Questionnaire: See ECOG and NRG protocols for details (links above).

Who reviews my credentials?

A joint committee constituted by ECOG/RTOG surgeons is co-chaired by Drs. Holsinger and Ferris.  These nine experienced transoral endoscopic head and neck surgeons meet by teleconference every 1-2 weeks to review new or revised case submissions, to establish criteria for approval, on-hold status and ongoing quality assurance.