Trial Comparing Avg. Global Qual of Lifescore in Hypo Frac. RT vs Conv. Frac. in H&N Cancers
NCT Number: NCT06536699
Acronym: HYPORT-HN
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Radiation Treatment
Interventions: RADIATION: Radiotherapy - hypofractionated|RADIATION: Radiotherapy - Conventional
Sponsor: Tata Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-07
Completion Date: 2031-07-01
Locations: Tata Medical Center, Kolkata, West Bengal, 700160, India

Summary:
Radiotherapy forms an integral part of Head and Neck cancer treatment in both definitive as well as adjuvant setting. This study explores the use of hypofractionated radiotherapy, delivering 55Gy in 20 fractions over 4 weeks in comparison to the conventional approach which involves 70 Gy over 6 weeks.

Hypofractionated radiotherapy would result in significant benefits in terms of shortening the overall treatment time, countering accelerated hypofraction effects that typically arise after the 4th week. The new approach is also anticipated to offer resource and financial advantages, involving less machine time per patient, and potentially leading to better patient compliance. Previous studies on hypofractionation in Head and Neck cancer have demonstrated good local control and acceptable toxicity levels compared to conventional methods.

The primary objective of this study is to compare the average global quality of life following hypofractionated radiotherapy versus conventional fractionation, with secondary objectives including a comparison of locoregional control at 2 years and assessment of acute and late toxicities.

The study will require 600 eligible patients randomly assigned to either the hypofractionated or conventional arm. For definitive chemoradiation, the control arm will receive 66Gy in 30 fractions over 6 weeks, while the experimental arm will receive 55Gy in 20 fractions over 4 weeks, along with Inj Cisplatin @ 100mg/m2 3 weekly for 2 cycles. In the adjuvant setting control arm will receive 60Gy in 30 fractions over 6 weeks and experimental arm will receive 52.5Gy in 20 fractions over 4 weeks along with Inj Cisplatin @ 100mg /m2 3 weekly for 2 cycles for both arms based on histopathological indications.

Physician reported and patient reported acute toxicities like mucositis, dermatitis and dysphagia, weight loss, requirement and duration of feeding tubes as well as patients reported outcomes in the form of EORTC QLQ C30, HN43 and XeQoLS will be recorded both during and after treatment at regular intervals for 2 years.

The study's duration is five years, aiming to determine whether the hypofractionated schedule is non-inferior to conventional radiotherapy in terms of safety and disease-related outcomes

Primary Outcome Measures: To compare the average global quality of life score following hypofractionated radiotherapy versus conventional fractionation in head and neck cancer, Patients reported outcomes in the form of EORTC QLQ C30 questionnaire at regular designated intervals using electronic patient reported outcome monitoring systems (e-PROMS).

EORTC QLQ C30 stands for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30.

The score will range from 0 to 100 as per the Scoring of the EORTC QLQ-C30 version 3.0.

A higher score will denote a better quality of life., 2 Years
Secondary Outcome Measures: To compare the locoregional control at 2 years between the hypofractionated and conventional arm., To get a Radiological assessment done 3 months post treatment and then followup the patient clinically and only get a radiological correlation if suggested clinically., 2 Years|To compare acute and late toxicities of hypofractionated radiotherapy with conventional fractionation, To compare physician reported and patient reported acute toxicities like mucositis, dermatitis and dysphagia between the two groups using weekly assessment of acute toxicities using the RTOG and CTCAE v5 criteria during radiation., 2 Years