Trial Comparing Avg. Global Qual of Lifescore in Hypo Frac. RT vs Conv. Frac. in H&N Cancers

NCT06536699 | Not Yet Recruiting DMC

• 1 other identifier: 2024/TMC/307/IRB11
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Radiation Treatment

Keywords

Hypofractionated radiotherapy; Head and Neck cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• To compare the locoregional control at 2 years between the hypofractionated and conventional arm.

  2 Years

• To compare acute and late toxicities of hypofractionated radiotherapy with conventional fractionation

  2 Years

Study Arms (2)

Radiotherapy - conventional

ACTIVE COMPARATOR

Conventional Radiotherapy of 66 Gy in 30 fractions in definitive setting and 60 Gy in 30 fractions in adjuvant setting Total Duration- 6 weeks

Radiation: Radiotherapy - Conventional

Radiotherapy - hypofractionated

EXPERIMENTAL

Hypofractionated Radiotherapy of 55 Gy in 20 fractions in definitive setting and 52.5 Gy in 20 fractions in adjuvant setting. Total duration - 4 Weeks

Radiation: Radiotherapy - hypofractionated

Interventions

Radiotherapy - hypofractionated RADIATION

Hypofractionated Radiotherapy of 55 Gy in 20 fractions in definitive setting and 52.5 Gy in 20 fractions in adjuvant setting. Total duration - 4 Weeks

Radiotherapy - hypofractionated

Radiotherapy - Conventional RADIATION

Conventional Radiotherapy of 66 Gy in 30 fractions in definitive setting and 60 Gy in 30 fractions in adjuvant setting. Total duration - 6 Weeks

Radiotherapy - conventional

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• ECOG performance status 0 - 2.
• Patients diagnosed with invasive squamous cell cancer of the head and neck region which includes lip, oral cavity, nasopharynx, oropharynx, hypopharynx, supraglottis, glottis and subglottis.
• Patients who are being treated with curative intent treatment either with surgery followed by adjuvant radiotherapy with or without chemotherapy or definitive chemoradiation.
• Patients must have a histopathological proof of malignancy, such as biopsy or post operative histopathology report. Biopsies or surgeries done outside must have been reviewed for pathological confirmation and specimen adequacy at the treating institute.
• Patients with non metastatic cancer, optimally staged with the following:
• Contrast enhanced CT scan of the neck and thorax for cancer lip, oral cavity, oropharynx, hypopharynx, supraglottis, glottis and subglottis
• Magnetic Resonance Imaging of the neck and CT thorax for cancer of nasopharynx

You may not qualify if:

• Concurrent illness like severe cardiac, renal or hepatic dysfunction and, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
• Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.

Sponsors & Collaborators

• Tata Medical Center: lead

Study Sites (1)

Tata Medical Center

Kolkata, West Bengal, 700160, India

Location

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  PMID: 33538338 RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Study Officials

• Sanjoy Sanjoy, MRCP,FRCR

  Tata Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanjoy Sanjoy, MRCP,FRCR

CONTACT

9038161825; sanjoy.chatterjee@tmckolkata.com

Indranil Mallick, MD, DNB

CONTACT

9831171235; indranil.mallick@tmckolkata.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparison of a shorter course of radiotherapy in 4 weeks with standard treatment of 6 weeks for head and neck cancers

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: August 5, 2024
• Study Start: August 7, 2024
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2031
• Last Updated: August 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

IN (1)