Observational study for patients with locally advanced head and neck carcinoma receiving definitive or adjuvant chemoradiation, outside of a clinical trial.
- Conditions
- Health Condition 1: null- Patients with locally advanced squamous cell or undifferentiated carcinoma of the head and neck region
- Registration Number
- CTRI/2014/08/004906
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 1500
1. Histological or cytological proven diagnosis of squamous cell or undifferentiated carcinoma of the head and neck region or squamous cell carcinoma of the head and neck region of unknown primary.
2. Planned for or has received curative intent concurrent chemoradiotherapy, either in the definitive or adjuvant setting.
3. Prescreen failure or screen failure of trial no 838/ 937
1. Recruited on either of below mentioned protocol:
i) Phase III non-inferiority randomized trial comparing three-weekly Cisplatin versus weekly Cisplatin in combination with radiation therapy in patients with advanced carcinoma of the head and neck( TMH NO-937)
ii) â??An Open label, Randomized, Investigator Initiated Multicentric, Phase III Study of Nimotuzumab in combination with Concurrent Radiotherapy and Cisplatin versus Radiotherapy and Cisplatin alone, in Subjects with Locally advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)â?? (TMH NO: 838)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reasons for prescreen and screen failure <br/ ><br>Locoregional control <br/ ><br> <br/ ><br>Secondary: <br/ ><br>Response rate( where applicable) <br/ ><br>Toxicity, <br/ ><br>Compliance to treatment, <br/ ><br>Disease free survival <br/ ><br>Progression-free survival, <br/ ><br>Overall survival, <br/ ><br>Quality of life <br/ ><br> <br/ ><br>The type and frequency of tests, admissions, outpatient visits, etc, will be standard and not part of the study. The above parameters will be recorded as part of our observational study <br/ ><br>Timepoint: 6-8 weeks after completion of CTRT, to assess response. Then every 3 months, and when there is clinical evidence of progression.
- Secondary Outcome Measures
Name Time Method Response rate( where applicable) <br/ ><br>Toxicity, <br/ ><br>Compliance to treatment, <br/ ><br>Disease free survival <br/ ><br>Progression-free survival, <br/ ><br>Overall survival, <br/ ><br>Quality of life <br/ ><br> <br/ ><br>The type and frequency of tests, admissions, outpatient visits, etc, will be standard and not part of the study. The above parameters will be recorded as part of our observational study <br/ ><br>Timepoint: Start of CTRT, weekly during therapy, at completion of CTRT, then every 3 months for 2 years.