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NOT YET RECRUITING
NCT05144100
PHASE2/PHASE3

Surgery Vs Chemoradiation for Oropharyngeal Cancer- A Phase II/III Integrated Design Randomized Control Trial

Sponsor: Tata Memorial Centre

View on ClinicalTrials.gov

Summary

The oropharyngeal areas mainly comprises of the tonsil, base tongue (BOT), soft palate and the posterior pharyngeal wall. Traditionally, surgical resection of oropharyngeal cancers (OPC) was a standard procedure, often performed through mutilating incisions with mandibulotomies, rendering significant post-operative functional deficits. Over the past 2 decades, there has been a major shift in treatment strategy with a majority of these cancers now being treated by primary concurrent chemoradiation (CCRT) with a trend towards organ and function preservation.

Official title: Primary Surgery Vs Primary Chemoradiation for Oropharyngeal Cancer (Scope Trial) - A Phase II/III Integrated Design Randomized Control Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

498

Start Date

2021-12-01

Completion Date

2031-06-30

Last Updated

2021-12-03

Healthy Volunteers

Yes

Interventions

PROCEDURE

Surgery with or without Neck Dissection

An appropriate surgery as open, endoscopic, TLM, TORS or a combination with or without neck dissection e.g. levels dissected, sparing or sacrifice of the SCM, accessory nerve, etc as per patient disease and status will be performed

RADIATION

Radiation

Patients will receive IMRT with normal tissue sparing techniques (70Gy/35# or 66Gy/ 30#) along with concurrent weekly cisplatin. Weekly cisplatin will be administered during IMRT at a dose of 40 mg/m2 IV on days 1, 8, 15, 22, 29, 36, and 43 for a total of upto 7 weekly doses, administered during the course of IMRT.

DRUG

Cisplatin based chemotherpay

Cisplatin (dose-40 mg/m2weekly,upto6-7cycles) cycle 1 will be administered within first 2 # of radiation. The rest of the cycles will be given weekly.

Locations (1)

Tata Memorial Hospital

Mumbai, Maharashtra, India