Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Arm A : Carboplatin: Radical radiation ( conventional or altered fractionation) + weekly Carboplatin (AUC 2 every week for 7 cycles or till radiotherapy gets over)
Patients would will
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants for radical or adjuvant CTRT for a histologically confirmed squamous cell of locally advanced head and neck region. 2. Age : Any age above 18 years. No maximum age. 3. ECOG performance status �2 4. Participants must be unfit for Cisplatin
Exclusion criteria
Exclusion criteria: 1. Participants who are receiving any other investigational agents. 2. Primary sites of malignancy major salivary gland or nasopharynx or skin 3. Patients with uncontrolled comorbidities precluding the use of docetaxel or Carboplatin 4. Uncontrolled comorbidities including active autoimmune disease that might deteriorate when receiving a chemotherapeutic agent. Clinically significant (i.e., active)cardiovascular disease: cerebrovascular accident/stroke (less than 6 months prior to enrollment), myocardial infarction (less than 6 months prior to enrollment), unstable angina, congestive heart failure (greater than equal to New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication. Patients with severe renal and liver dysfunction Child pugh B or C 5. Prior organ transplantation including allogeneic stem-cell transplantation. 6. Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI-CTCAE v5.0 Grade � 3). 7.Pregnant and lactating women are excluded from this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To compare 2 year OS between docetaxel based CTRT (D-CTRT) and Carboplatin with RT (C-CTRT)Timepoint: at 2 years post treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| a. To compare 2 year DFS between docetaxel based CTRT (D-CTRT) and Carboplatin RT (C-CTRT) b. To compare acute and late toxicity between docetaxel based CTRT (D-CTRT) and Carboplatin RT (C-CTRT) c. To compare improvement in TOI between 2 arms at 6 months, 12 months and at 24 months Timepoint: at 6 months, 12 months and at 24 months post treatment | — |
Countries
India
Contacts
Public ContactDr Kumar Prabhash
Tata Memorial Hospital
Outcome results
None listed