| CTRI Number |
CTRI/2025/09/094454 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Radiation Therapy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Preserve Tongue Function Using Chemotherapy, Immunotherapy, and Radiation in Patients with Advanced Tongue Cancer |
|
Scientific Title of Study
|
A phase II study for PREServing TOngue with Neoadjuvant chemoimmunotherapy and chemoradiation in advanced tongue cancers: PRESTO study |
| Trial Acronym |
PRESTO |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shwetabh Sinha |
| Designation |
Associate Professor, TMH , Mumbai |
| Affiliation |
TATA MEMORIAL HOSPITAL |
| Address |
Department of Radiation oncology Room No. 21,Proton centre, ACTREC, Kharghar, Navi Mumbai
MAHARASHTRA
410210
India
OPD No. 206, 2nd floor Homi Bhabha block , Tata Memorial hospital,Dr. Ernest Borges Road Parel Mumbai 400012
Mumbai
MAHARASHTRA
Raigarh
MAHARASHTRA
410210
India |
| Phone |
02224177262 |
| Fax |
|
| Email |
shwetabhsinha23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shwetabh Sinha |
| Designation |
Associate Professor, TMH , Mumbai |
| Affiliation |
TATA MEMORIAL HOSPITAL |
| Address |
Department of Radiation oncology Room No. 21,Proton centre, ACTREC, Kharghar, Navi Mumbai
MAHARASHTRA
410210
India
OPD No. 206, 2nd floor Homi Bhabha block , Tata Memorial hospital,Dr. Ernest Borges Road Parel Mumbai 400012
Mumbai
MAHARASHTRA
Raigarh
MAHARASHTRA
410210
India |
| Phone |
02224177262 |
| Fax |
|
| Email |
shwetabhsinha23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shwetabh Sinha |
| Designation |
Associate Professor, TMH , Mumbai |
| Affiliation |
TATA MEMORIAL HOSPITAL |
| Address |
Department of Radiation oncology Room No. 21,Proton centre, ACTREC, Kharghar, Navi Mumbai
MAHARASHTRA
410210
India
OPD No. 206, 2nd floor Homi Bhabha block , Tata Memorial hospital,Dr. Ernest Borges Road Parel Mumbai 400012
Mumbai
MAHARASHTRA
Raigarh
MAHARASHTRA
410210
India |
| Phone |
02224177262 |
| Fax |
|
| Email |
shwetabhsinha23@gmail.com |
|
|
Source of Monetary or Material Support
|
| The project funded by ICMR/intramural/extramural |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr. E Borges Road, Parel, Mumbai - 400 012 India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shwetabh Sinha |
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) |
Department of Radiation oncology Room No 21 Proton Centre, Kharghar Navi Mumbai
Raigarh
MAHARASHTRA |
02224177262
shwetabhsinha23@gmail.com |
| Dr Shwetabh Sinha |
Tata Memorial Hospital |
OPD No. 206 2nd floor Homi Bhabha block, Dr. Ernest Borges Road, Parel, Mumbai 400012
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
02224177262
shwetabhsinha23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee II |
Approved |
| Institutional Ethics Committee II |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C029||Malignant neoplasm of tongue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CTRT |
Patients who respond to chemoimmunotherapy,will be considered eligible for Concurrent Chemoradiotherapy (CTRT).The radiation oncologist will allow Both protons and photons for CTRT as deemed suitable. |
| Comparator Agent |
NA |
NA |
| Intervention |
Nivolumab 40mg |
Nivolumab 40mg iv every 3 weekly will be given for 3 cycles along with the NACT |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Stage III/ Stage IV (AJCC 8th edition) Squamous Cell Carcinoma of Tongue
2. Upfront Resectable (as deemed by a DMG surgeon)
3. N stage: N0-N2c (AJCC 8th edition)
4. Requiring Major Glossectomy (Type IV/ Type V-Ansarin Classification) (22)
5. With CPS score more than equal to 1 on Bx (IHC)
|
|
| ExclusionCriteria |
| Details |
1.N3a/N3b tumors (AJCC 8th edition)
2.Unresectable at baseline
3.Recurrent Tumors
4.Having Received other cancer-directed treatment
5.Verrucous lesions
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy and safety of neoadjuvant chemoimmunotherapy and chemoradiation for tongue preservation in patients requiring a major glossectomy |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify a subgroup of Indian oral cavity cancer patients who have a good response to Neoadjuvant chemoimmunotherapy |
2.5 years |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |