Evaluation of Severe Oral Mucositis in Locally Advanced Unresectable Head and Neck Squamous Cell Carcinoma (HNSCC) Patients Treated by Chemoradiotherapy (CTRT) Using Volumetric Modulated Arc Therapy (VMAT) with Simultaneous Integrated Boost (SIB) A Single Institution Prospective Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- To evaluate severe oral mucositis RTOG grade less than and equal to grade 3 in unresectable HNSCC treated with VMAT SIB along with concurrent cisplatin using RTOG Acute Morbidity Criteria Objective criteria and Mouth and Throat soreness score MTS and QLQ C30 HN questionnaires subjective patient reported criteria and their correlation.
Study Overview
Brief Summary
Evaluation of Severe Oral Mucositis in Locally Advanced Unresectable Head and Neck Squamous Cell Carcinoma HNSCC Patients Treated by Chemoradiotherapy CTRT Using Volumetric Modulated ARC Therapy VMAT with Simultaneous Integrated Boost SIB A Single Institution Prospective Study
Head and neck carcinomas are the most common cancer in India with oral cavity being the most common subsite and squamous cell carcinoma being the most common histology. After 1970s Radiotherapy RT became the primary treatment modalities of head and neck squamous cell carcinoma HNSCC except Oral cavity often in combination with chemotherapy. RT plays major role in loco regional control in HNSCC.
Radiotherapy is delivered by using varying techniques. IMRT VMAT plays a critical role in the management of patients with head and neck HN cancer. The advantage of IMRT VMAT over older conventional techniques is that it can conform the dose to any complex target volume and avoid critical Organs at Risk OARs.
Oral mucositis is a frequent and distressing complication of adjuvant RT in patients treated for head and neck cancers. It significantly impairs oral intake quality of life and may necessitate treatment breaks thereby compromising oncologic outcomes. After MACHNC metaanalysis CTRT became the cornerstone of treatment of locally advanced HNSCC. The loco regional control survival outcome and toxicity depend on multiple factors. In this prospective study we have tried to correlate various host factors tumour factors and laboratory values to the survival outcome and toxicity. This study will prospectively analyse Institute patient data and tally this with western data and other Indian population data to compare severe RT induced oral mucositis rate RTOG grade grade 3 evaluate QoL by Mouth and Throat soreness score MTS and QLQC30 HN questioner and assess the need of feeding tube hospitalization rate opioid use and significant weight loss 5 kg and evaluate impact of various host and tumour related factor with treatment outcome and survival.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Histologically proven HNSCC (Except Oral cavity)
- •18 to 70 years
- •ECOG Score 2 or less
- •Non-metastatic disease (T1-T4a, N0-3b).
- •Patients planned for radical treatment with chemo-radiation with dose of RT 66Gy in 30 fractions
- •Patient being treated using VMAT-SIB technique with concurrent cisplatin.
- •Willingness to sign informed consent form.
Exclusion Criteria
- •Any histopathology other than SCC
- •Previous radiotherapy to the head and neck region
- •Synchronous or metachronous malignancy
- •Pregnant or lactating women
- •Evidence of distant metastasis (any T, any N, M1).
- •Recurrent or residual disease
- •Oral cavity SCC patients
- •Any other concurrent chemotherapy other than cisplatin.
Outcomes
Primary Outcomes
To evaluate severe oral mucositis RTOG grade less than and equal to grade 3 in unresectable HNSCC treated with VMAT SIB along with concurrent cisplatin using RTOG Acute Morbidity Criteria Objective criteria and Mouth and Throat soreness score MTS and QLQ C30 HN questionnaires subjective patient reported criteria and their correlation.
Time Frame: Patients will be assessed at least once weekly during radiation. The first post treatment visit will be 1 weeks after completion of radiotherapy. Subsequent visits will be 1 month and 3 month post RT.
Secondary Outcomes
- To evaluate other acute toxicities like skin reaction, dysphagia, odynophagia.(• To assess the need of)
Investigators
Dr Ashutosh Mukherji
Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital