Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Modified TPF: Docetaxel @ 50 mg per square metre, administered as a 1 hour intravenous infusion in normal saline over 1 hour (day 1)
CDDP @ 50 mg per square metre, administered as an
Sponsors
AIIMS, New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Histologically confirmed squamous cell carcinoma of the oral cavity Patients with a resectable lesion, with clinical stage III or IVA disease (T3N0 or T1-3N1-2M0 or T4aN0-2M0 according to Union for International Cancer Control [2018]). ECOG PS 0-1 Meeting the following standard values of general laboratory tests completed within 7 days prior to randomization and values are within the parameters required by the protocol: a) WBC count more than 4,000/µL, hemoglobin more than 8 g/L, platelet count more than 100,000/µL b) ALT and AST less than 2.5× the upper limit of normal c) Total bilirubin less than 1.5× the upper limit of normal d) Serum creatinine less than 1.5× the upper limit of normal Written informed consent.
Exclusion criteria
Exclusion criteria: Distant metastasis or other cancers Have undergone surgery involving primary tumor or lymph nodes (except diagnostic biopsy) Have received any prior radiotherapy or chemotherapy Have had other malignancies within 5 years Have creatinine clearance less than 60 mL/min. Cisplatin ineligible patients Unstable angina within 3 weeks, or with a history of myocardial infarction within last 6 months Pregnant or breastfeeding females or those not willing for contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare between the two study arms the overall response rates after neoadjuvant chemotherapyTimepoint: 12-14 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess patient-reported outcomes using the EORTC H&N 43 & EORTC QLQ-C30 questionnaire in both study groups.Timepoint: 0 weeks, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks in Arm B 0 weeks, 3 weeks, 6 weeks, 9 weeks in Arm A;Assessment of tumor shrinkage pattern & margin sterility, pre & post NACTTimepoint: 16 weeks;Compare the accuracy of contrast-enhanced CT vs 18FDG-PET-CT in predicting complete pathological & major pathological response post NACT in both arms Timepoint: 16 weeks;Evaluate major pathological response in primary tumor in both armsTimepoint: 16 weeks;Evaluate the incidence & severity of adverse events according to the CTCAE v5.0 criteria in both armsTimepoint: 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks in Arm B 3 weeks, 6 weeks, 9 weeks, 12 weeks in Arm A;Evaluate the rate of pathologic complete response (pCR) in both arms (primary tumor & node)Timepoint: 16 weeks;To study genetic signatures of tumors with favourable as well as unfavourable pathological responseTimepoint: 20 weeks | — |
Countries
India
Contacts
Public ContactDr Akash Kumar
AIIMS, New Delhi
Outcome results
None listed