Health Condition 1: C119- Malignant neoplasm of nasopharynx,unspecified
Conditions
Interventions
Intervention1: Docetaxel Cisplatin (TP Regimen): All Stage III & IVA, Locoregionally advanced nasopharyngeal carcinoma patients
attending the Head and Neck Multidisciplinary Tumor Clinic, JIPMER and m
Sponsors
Jawaharlal Institute of Postgraduate Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: Patients will be eligible for inclusion in the study if they fulfilled all the following criteria: Histologically confirmed, treatment-na�¯ve, Locoregionally advanced nasopharyngeal carcinoma patients (Stage III & IVA-, as per AJCC 8th Edition), Aged between >18 years- 60 years of age, Good performance status (ECOG-0-2), With adequate organ function at time of participation defined as: - 1. Hemoglobin â�¥ 9 gm/dl; ANC â�¥ 1500/mm3, Platelet Count â�¥ 1,00,000/mm3 2. Liver Function Test: Bilirubin â�¤ 2x upper limit of normal (ULN), AST/ALT/ALP â�¤ 2.5 x ULN 3. Renal Function Test: Creatinine â�¤ 1.5 ULN, Creatinine clearance â�¥ 60ml/min. Willing for treatment adherence, and willing for written informed consent
Exclusion criteria
Exclusion criteria: Any of the following- 1. Patients with previous history of anti-cancer treatment, head and neck radiotherapy. 2. Patients with uncontrolled comorbidities or life-threatening diseases 3. Pregnant patient 4. Patients with distant metastases. 5. Patients with synchronous primary tumor 6. Evidence of moderate to severe hearing loss (as per Pure Tone Audiometry)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To determine loco-regional control rate (LRCR), Overall response rate of TP regimen as induction chemotherapy in locoregionally advanced nasopharyngeal carcinoma 2. To evaluate the tolerability of TP regimen as induction chemotherapy in locoregionally advanced nasopharyngeal carcinoma in terms of acute toxicities and late toxicities at 6 months. (For Thesis purpose as a co-primary objective). Timepoint: 6 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine the initial response of induction chemotherapy on gross tumor volume after 2-3 cycles.Timepoint: 3 Months;2. To determine effect of induction chemotherapy on administration of concurrent chemoradiation in terms of compliance.Timepoint: 3 Months;3. To determine Progression free survival (PFS), Distant metastasis free survival (DMFS), Local relapse free survival (LRFS), Regional relapse free survival (RRFS), Overall Survival (OS), Time to tumor Progression (TTP) of induction chemotherapy (TP Regimen) followed by CCRT in locoregionally advanced nasopharyngeal carcinoma at 6 months.Timepoint: 6 Months;4. To assess the Quality of Life (QOL) of the patients at baseline, post treatment at the end of 3 months.Timepoint: 3 Months | — |
Countries
India
Contacts
Public ContactBhargav Shreeram Gundapuneedi
Jawaharlal Institute of Postgraduate Medical Education and Research
Outcome results
None listed