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Clinical Trials/CTRI/2025/09/094454
CTRI/2025/09/094454Not yet recruitingPhase 2

A phase II study for PREServing TOngue with Neoadjuvant chemoimmunotherapy and chemoradiation in advanced tongue cancers: PRESTO study

Tata Memorial Hospital2 sites in 1 country45 target enrollmentStarted: September 30, 2025Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Enrollment
45
Locations
2
Primary Endpoint
To assess the efficacy and safety of neoadjuvant chemoimmunotherapy and chemoradiation for tongue preservation in patients requiring a major glossectomy

Study Overview

Brief Summary

Advanced tongue cancers are treated with surgery (which involves removal of the affected part of tongue) and removal of lymph nodes from the neck. This is followed by 6-7 weeks of radiation therapy (RT) (a form of cancer treatment which involves killing of cancer cells with high energy X-rays). Chemotherapy (medicines used to kill cancers cells) can be combined with RT to increase the effect of RT. This is called as CTRT.

 Removal of large part of tongue followed by RT/ CTRT leads to problems which impact the day to day life of many patients after treatment. These include swallowing difficulty, unclear speech, loss of taste etc.

 Immunotherapy is a relatively new form of cancer treatment which enhances the capability of body to destroy cancer cells. It is available as a medicine similar to chemotherapy

 In this study we are combining chemotherapy, immunotherapy and RT in an attempt to preserve your tongue. We will first give patients with advanced tongue cancer a combination of chemotherapy and immunotherapy. After this in patients a good amount of reduction in the cancer, we will offer these patients CTRT. Hence, in these patient’s surgery will be omitted.

 We believe that with this approach, we will be able to preserve the tongue in a significant number of tongue cancer patients who otherwise would have required removal of large parts of their tongue. We also believe that with this approach patients will be able to have a much better quality of life after treatment without impacting the cancer control rates.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Stage III/ Stage IV (AJCC 8th edition) Squamous Cell Carcinoma of Tongue
  • Upfront Resectable (as deemed by a DMG surgeon)
  • N stage: N0-N2c (AJCC 8th edition)
  • Requiring Major Glossectomy (Type IV/ Type V-Ansarin Classification) (22)
  • With CPS score more than equal to 1 on Bx (IHC).

Exclusion Criteria

  • 1.N3a/N3b tumors (AJCC 8th edition) 2.Unresectable at baseline 3.Recurrent Tumors 4.Having Received other cancer-directed treatment 5.Verrucous lesions.

Outcomes

Primary Outcomes

To assess the efficacy and safety of neoadjuvant chemoimmunotherapy and chemoradiation for tongue preservation in patients requiring a major glossectomy

Time Frame: 1 year

Secondary Outcomes

  • To identify a subgroup of Indian oral cavity cancer patients who have a good response to Neoadjuvant chemoimmunotherapy(2.5 years)

Investigators

Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Shwetabh Sinha

TATA MEMORIAL HOSPITAL

Study Sites (2)

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