Health Condition 1: C131- Malignant neoplasm of aryepiglottic fold, hypopharyngeal aspect
Conditions
Interventions
Intervention1: Neoadjuvant Chemotherapy (NACT) followed by Adjuvant Therapy Arm: Patients randomized to NACT arm will be given 2 cycles of chemotherapy with DCF and then response assessment of disease
Sponsors
TMC Research Administrative Committee
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18+ years 2. Hypopharynx squamous cell carcinoma proven by histology, stage III/IV M0, eligible for laryngo-pharyngectomy 3.Functional larynx- defined as patients who are: a. not dependent on tracheostomy tube b. not dependent on feeding tube in view of tumour related dysphagia c. no history of recurrent pneumonia requiring hospitalization 4. Performance status ECOG 0-1 5. Neutrophils more than equal to 1.5 x 109/l, Platelets count more than equal to 100 x 109/l, haemoglobin more than equal to 10 g/dl 6. Total bilirubin less than equal to 1.5 x upper reference range 7. ASAT and ALAT less than equal to 2.5 x upper reference range, alkaline phosphatases less than equal to 5 x upper reference range 8. Serum creatinine greater than equal to 50 cc/min 9. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Clinical/radiological evidence of gross cartilage erosion 2. History of any prior cancer directed treatment for this disease 3. Uncontrolled co-morbidities eg hypertension, diabetes mellitus, coronary artery disease, COPD, Tuberculosis. 4. Active infection with HIV, HCV, HBV 5. Severe sensorineural hearing loss 6. Pregnant women 7. Patients with dysfunctional larynx.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate if NACT followed by definitive therapy in stage III/IV M0 hypopharyngeal squamous cell cancers improves disease free survival compared to upfront definitive CCRT.Timepoint: Date of randomization (after accrual) to date of the first episode of disease recurrence or progression or death. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall SurvivalTimepoint: Date of randomization (after accrual) to date of death;Laryngectomy free survivalTimepoint: Date of randomization (after accrual) to date of total laryngectomy or death;Functional larynx preservationTimepoint: Date of randomization to date of any death, local disease recurrence, total laryngectomy, tracheostomy and/or feeding tube placement after therapy (i.e. week 20), and tracheostomy and/or feeding tube persistence recorded after 24 months;QOLTimepoint: Baseline, 6 months, 12 months and at 24 months post-treatment completion between the 2 arms | — |
Countries
India
Contacts
Public ContactDr Sarbani Ghosh Laskar
Tata Memorial Hospital
Outcome results
None listed