Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Neoadjuvant Chemotherapy plus Chemoradiation(Toripalimab plus Cisplatin): Toripalimab will be administered at 3 weekly intervals for 3 doses followed by response assessment,
Paclitaxe
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults (aged 18 years and above) with histologically or cytologically proven locally advanced squamous cell carcinoma of the head and neck (larynx, hypopharynx, oropharynx, oral cavity), and CUP neck nodes stage III and IV, who are planned for definitive chemoradiation. 2. Participants should have an ECOG performance status (PS) of 0-2 3. Participants must have normal organ and marrow function as defined below: a. Leukocytes equal to or more than 3,000/mcL b. Platelets equal to or more than 100,000/mcL c. Total bilirubin equal to or less than 1.5 times the institutional upper limit of normal d. AST(SGOT) or ALT(SGPT) equal to or less than 1.5 times the institutional upper limit of normal (ULN) e. Calculated Creatinine clearance greater than 30 ml/min 4. Willing and able to comply with all study requirements 5. Able to understand and be willing to sign a written informed consent document. 6. Both participants eligible for Cisplatin-based concurrent chemoradiation and those who are Cisplatin ineligible will be included.
Exclusion criteria
Exclusion criteria: 1. Participants with nasopharyngeal carcinoma, sino-nasal cancers, and salivary gland malignancies. 2. Participants who have received prior chemoradiation to the head and neck region. 3. Participants with known hypersensitivity to any of the study agents 4. Pregnant and breastfeeding women. 5. Participants with HIV, active Hepatitis B, and active Hepatitis C infection 6. Participants with active, known, or suspected autoimmune diseases. Participants with vitiligo, type I diabetes mellitus, and residual hypothyroidism due to autoimmune conditions only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrol. 7. Participants who have undergone an organ or stem cell transplant. 8. Participants with a condition requiring systemic treatment with either corticosteroids (greater than 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses greater than 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survivalTimepoint: At 2 years from the date of randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survivalTimepoint: Time from randomisation till death due to any cause.;Locoregional control rate (LRC) at 2 yearsTimepoint: Locoregional control rate (LRC) at 2 years defined as number of patients without locoregional failure at 2 years.;Duration of locoregional control (LRC).Timepoint: Duration of LRC is defined as the time between the date of randomization and the date of locoregional failure;Objective response rateTimepoint: Patients who achieve a complete response and partial response as per RECIST 1.1;Safety (adverse events as per CTCAE v5.0, both acute and late toxicities)Timepoint: ;Compliance with neoadjuvant therapyTimepoint: ;Compliance with concurrent chemo-radiationTimepoint: ;Number undergoing salvage surgery after definitive chemoradiationTimepoint: | — |
Countries
India
Contacts
Public ContactDr NANDINI MENON
Tata Memorial Hospital
Outcome results
None listed