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.
Histopathology proven diagnosis of squamous cell carcinoma of the oropharynx, localized to the tonsil and/or lateralized tongue-base
ECOG Performance Status ≤2
Age ≥18 to 70 years
Anesthetic fitness obtained for surgery under general anesthesia
Prior head and neck malignancy
Prior invasive malignancy, unless disease free for a minimum of 3 years
Prior chemotherapy for a different cancer administered within 3 years prior to registration
Patients who have received any neoadjuvant/ induction chemotherapy
Parallel
Surgery with or without Neck Dissection
Procedure/SurgeryAn 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
RadiationPatients 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
DrugCisplatin (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.
Event Free Survival.(EFS)
Event Free Survival will be defined as the time between the date of randomization till the date of recurrence of the disease (either local, regional or distant failure) or death due to disease.
Overall Survival (OS)
Overall Survival (OS) will be defined as the time between the date of randomization and the date of death due any cause
Disease free survival (DFS)
Disease free survival (DFS) will be defined as the time between the date of randomization till the date of recurrence or second primary disease (either locoregional or distant).
Progression free survival (PFS)
Progression of disease would be defined as an increase in any dimension of the disease or recurrence of disease
Locoregional control (LRC)
Locoregional control (LRC) will be defined as the time between the date of randomization and the date of local or regional failure
Subjective Swallowing function
evaluate the swallowing function using MBS with/without video assisted measure (Functional Endoscopic Evaluation of Swallo (FEES) or videofluroscopy)
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Tata Memorial Centre
Lead sponsor
All India Institute of Medical Sciences
Collaborator
Amrita Institute of Medical Sciences & Research Center
Collaborator
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