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

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTata Memorial Centre

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Surgery with or without Neck Dissection
  • Radiation
  • Cisplatin based chemotherpay

Treatment groups

498 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Tata Memorial Centre

Lead sponsor

All India Institute of Medical Sciences

Collaborator

Amrita Institute of Medical Sciences & Research Center

Collaborator