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

PHASE2/PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

498

Participants

Timeline

Start Date

December 1, 2021

Primary Completion Date

June 30, 2029

Study Completion Date

June 30, 2031

Conditions
Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8
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.

Trial Locations (1)

400012

Tata Memorial Hospital, Mumbai

All Listed Sponsors
collaborator

All India Institute of Medical Sciences

OTHER

collaborator

Amrita Institute of Medical Sciences & Research Center

OTHER

lead

Tata Memorial Centre

OTHER

NCT05144100 - Surgery Vs Chemoradiation for Oropharyngeal Cancer- A Phase II/III Integrated Design Randomized Control Trial | Biotech Hunter | Biotech Hunter