Trial comparing the effectiveness of daily radiation therapy plus a second daily radiation boost dose with daily radiation therapy plus three-weekly chemotherapy in advanced cancers of the head and neck.
Phase 3
Completed
- Conditions
- Health Condition 1: null- Locoregionally advanced squamous cell carcinoma of the head and neck
- Registration Number
- CTRI/2018/03/012579
- Lead Sponsor
- Bodhisattwa Dutta
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 96
Inclusion Criteria
Histologically proven squamous cell cancers of oropharynx, hypopharynx, or larynx.
AJCC stage T2N1-3M0 or T3-4N0-3M0.
ECOG PS 0-2.
No prior surgery except biopsy.
No prior chemotherapy and/or radiotherapy.
No evidence of uncontrolled cardiorespiratory, hepatic, renal, or hematological comorbidities.
Exclusion Criteria
Lack of histopathological proof.
Nonsquamous histology.
Sites like oral cavity, nasopharynx, nasal cavity, paranasal sinuses, salivary glands, orbit, brain, skin.
Prior surgery except biopsy.
Prior radiotherapy and/or chemotherapy.
Pregnancy or lactation.
Evidence of systemic metastases.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ocoregional ResponseTimepoint: 6 weeks from treatment completion.
- Secondary Outcome Measures
Name Time Method Acute ToxicitiesTimepoint: Weekly examination during treatment, 2 weeks after treatment completion, 6 weeks after treatment completion.;Death due to any causeTimepoint: Date of death, as communicated to the principal investigator.;Late ToxicitiesTimepoint: Regular follow up at 1-3 month intervals;Locoregional or Distant FailureTimepoint: 6 weeks from treatment completion, then regular follow ups at 1-3 months interval.