Weekly Paclitaxel versus weekly Cisplatin in Oral cavity, Oropharyngeal and Hypopharyngeal cancer patients with concurrent Radiation – A Superiority, Phase II/III - Randomised Controlled Trial

Phase 2

• Conditions: Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx

• Registration Number: CTRI/2023/11/060145
• Lead Sponsor: Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER Pondicherry

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Inclusion criteria :

1)Patients of biopsy proven squamous

cell carcinoma of oral cavity, oropharyngeal and hypo-pharyngeal cancer planned for radical radiation with concurrent chemotherapy after multidisciplinary tumor clinic discussion.2)Age > 18 yrs 3) ECOG performance status 0-2. 4) Adequate renal function (creatinine clearance >60 ml/min )

5) Normal liver function tests.

Exclusion Criteria

Exclusion criteria :

1)Age > 65yrs

2)Patients with distant metastasis.

3)Patients with uncontrolled hypertension, diabetes mellitus, ischemic heart disease.

4)H/o previous oncological surgery for the same condition.

5)H/o previous irradiation to the same site.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Endpoint : <br/ ><br>Proportion of treatment completion in all eligible patients. <br/ ><br>Weekly arm Paclitaxel : 5 to 7 cycles chemo during RT period. <br/ ><br>Weekly arm Cisplatin : 5 to 7 cycles chemo during RT period.Timepoint: From start of radiation treatment till completion of full course of radiation ( approximately 6-7 weeks for each patient )

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoint <br/ ><br>Acute toxicities during the course of treatment assessed weekly using CTCAE v5.0Timepoint: During full course of concurrent chemoradiation , till 1 month after completion of treatment