Dose escalation trial for squamous cell carcinoma of head and neck using FMISO PET CT
Phase 2
- Conditions
- Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
- Registration Number
- CTRI/2024/04/065373
- Lead Sponsor
- Varian Medical Systems Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Performance status: ECOG 0 – 2
2.Histology proved – squamous cell carcinoma
3.Tumour sites: Oral Cavity, Oropharynx, Hypopharynx and Larynx
4.Sufficient bone marrow reserve within the last 14 days.
5.Liver functions and kidney functions within normal limits
6.Nutritional and dental assessment before inclusion into the study
Exclusion Criteria
1.HPV (p16) positive tumours
2.Prior surgery and/or radiation therapy given for any HNC
3.T1/T2 Glottic cancer
4.Metastatic disease or disease not amenable for definitive locoregional treatment.
5.Medical co-morbidity hampering the administration of radiation and/or chemotherapy (cisplatin)
6.Pregnancy or lactation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ocoregional control (LRC)Timepoint: The duration of LRC was defined from the date of randomisation to the first histopathologically proven relapse of locoregional disease. If there is no proven recurrence, the LRC duration will be cut-off at the analysis point. <br/ ><br>First LRC analysis: 12 weeks post treatment. Subsequently, routine follow-up
- Secondary Outcome Measures
Name Time Method Overall Survival (OS)Timepoint: The duration of OS was defined from the date of surgery to death from any cause. Therefore, if there is no death (for any reason), the OS duration will be cut-off at the analysis.;Patient Reported Outcome (PRO)Timepoint: EORTC QLQ-C30 and QLQ-H and N35 questionnaires will be obtained from the QoL unit, EORTC Data Center in Brussels, Belgium. The EORTC QLQ-C30 questionnaire consists of five functional scales that include physical, role, cognitive, emotional, and social; three symptom scales that include fatigue, pain, and nausea/vomiting; a global QoL scale; and six single items that include dyspnea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties.;Toxicity - AcuteTimepoint: upto 6 months of treatment;Toxicity - LateTimepoint: At 1-year and 2-year