NCT06536699Not yet recruiting
Trial Comparing Avg. Global Qual of Lifescore in Hypo Frac. RT vs Conv. Frac. in H&N Cancers
A Randomised Non Inferiority Trial to Compare the Average Global Quality of Life Score Following Hypofractionated Radiotherapy Versus Conventional Fractionation in Head and Neck Cancers
Source: ClinicalTrials.gov · Last updated 5 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 1 Jul 2024
- Start date
- 7 Aug 2024
- Primary completion date
- 1 Jul 2029
- Lead sponsor
- Tata Medical Center
- Diseases
- Head and neck cancer
- NCT number
- NCT06536699
What you commit to
- Study type: Interventional
- Planned participants: 600
- From 7 Aug 2024 to the primary completion date, 1 Jul 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tata Medical Center Coordinator of this site? Confirm its status | Kolkata | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.