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Surgery Vs Chemoradiation for Oropharyngeal Cancer- A Phase II/III Integrated Design Randomized Control Trial
Sponsor: Tata Memorial Centre
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
Conditions
Interventions
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
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.
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