Improved Quality of Life in Advanced Tongue Cancers

Enhanced Long-Term Speech and Swallowing related Quality of Life after Neo-adjuvant Immuno-chemotherapy in Advanced Tongue Cancers - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/105756

Enrollment

Registered

2026-03-10

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C029- Malignant neoplasm of tongue, unspecified

Interventions

Intervention1: Neo-adjuvant immunochemotherapy: 2 cycles of Nivolumab + Paclitaxel + Docetaxel before surgery in advanced tongue cancers Intervention2: Arm b (neoadjuvant): 40 mg nivolumab, cisplatin

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients must be 18 years of age and older. 2. Pathologically confirmed SCC of oral tongue crossing the midline, technically resectable at baseline. 3. Tumour sample must be available for p16 and PD-L1 4. ECOG PS 0-1 5. Participants must have normal organ and marrow function.

Exclusion criteria

Exclusion criteria: 1. Early SCC of the tongue not crossing midline. 2. Technically unresectable/borderline resectable lesions at baseline. 3. Patients who have participated in a study with an investigational agent or device within 2 weeks of initiation of treatment. 4. Any prior radiotherapy to the neck 5. Any history of a severe hypersensitivity reaction to any monoclonal antibody 6. Any history of allergy to the study drug components 7. Any concurrent malignancies

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the composite MDADI score at 6 months post surgery ( 2 weeks). Timepoint: Baseline 6 months post surgery 12 months post surgery 24 months post surgery	—

Secondary

Measure	Time frame
Overall Survival (OS) and Disease-Free Survival (DFS)Timepoint: 3 years;Quality of life at other time points - using the EORTC QLQC30 and H&N43 scales, the Voice Handicap Index (VHI-10)Timepoint: 6 and 12 months post surgery;Toxicity as assessed by the National Cancer Institute Common Toxicity Criteria (NCICTC) version 5Timepoint: During treatment;Swallowing function, measured by: a. Feeding tube rate at 1-year post surgery b. MDADI subscale scores (physical, functional, emotional domains) Timepoint: 1 year post surgery	—

Measure

Time frame

Overall Survival (OS) and Disease-Free Survival (DFS)Timepoint: 3 years;Quality of life at other time points - using the EORTC QLQC30 and H&N43 scales, the Voice Handicap Index (VHI-10)Timepoint: 6 and 12 months post surgery;Toxicity as assessed by the National Cancer Institute Common Toxicity Criteria (NCICTC) version 5Timepoint: During treatment;Swallowing function, measured by: a. Feeding tube rate at 1-year post surgery b. MDADI subscale scores (physical, functional, emotional domains) Timepoint: 1 year post surgery

—

Countries

India

Contacts

Public ContactMeghna Kumar

Homi Bhabha Cancer Hospital and Research Centre, Muzaffarpur

meghna210393@gmail.com8095670212

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026