| CTRI Number |
CTRI/2024/05/068150 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of a shorter course of radiotherapy in 4 weeks with standard treatment of 6 weeks for head and neck cancers |
|
Scientific Title of Study
|
HYPORT HN-A randomized, non inferiority trial to compare the the average global quality of life score following HYPofractionated radiotherapy versus conventional fractionation in Head and Neck cancer |
| Trial Acronym |
HYPORT HN |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjoy Chatterjee |
| Designation |
Senior Consultant, Department of Radiation Oncology |
| Affiliation |
TATA MEDICAL CENTER |
| Address |
Consultant room number 1, Phase 1 ground floor, Department of Radiation Oncology,
Tata Medical Center, 14 MAR(E-W), New Town, Rajarhat, Kolkata-700160, West Bengal, India.
Kolkata
WEST BENGAL
700160
India |
| Phone |
9038161825 |
| Fax |
|
| Email |
chatterjee72@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjoy Chatterjee |
| Designation |
Senior Consultant, Department of Radiation Oncology |
| Affiliation |
TATA MEDICAL CENTER |
| Address |
Consultant room number 1, Phase 1 ground floor, Department of Radiation Oncology,
Tata Medical Center, 14 MAR(E-W), New Town, Rajarhat, Kolkata-700160, West Bengal, India.
Kolkata
WEST BENGAL
700160
India |
| Phone |
9038161825 |
| Fax |
|
| Email |
chatterjee72@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjoy Chatterjee |
| Designation |
Senior Consultant, Department of Radiation Oncology |
| Affiliation |
TATA MEDICAL CENTER |
| Address |
Consultant room number 1, Phase 1 ground floor, Department of Radiation Oncology,
Tata Medical Center, 14 MAR(E-W), New Town, Rajarhat, Kolkata-700160, West Bengal, India.
Kolkata
WEST BENGAL
700160
India |
| Phone |
9038161825 |
| Fax |
|
| Email |
chatterjee72@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Medical Center, 14 MAR(E-W), New Town, Rajarhat, Kolkata-700160, West Bengal, India. |
|
|
Primary Sponsor
|
| Name |
TATA MEDICAL CENTER KOLKATA |
| Address |
Tata Medical Center, 14 MAR(E-W), New Town, Rajarhat, Kolkata-700160, West Bengal, India |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjoy Chatterjee |
Tata Medical center |
Consultant room number 1, Phase 1 ground floor, Department of radiation oncology,
TATA Medical Center, 14 MAR (E-W), New Town, Rajarhat, Kolkata 700 160, West Bengal, India.
Kolkata
WEST BENGAL |
9038161825
chatterjee72@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review Board, TATA Medical Center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Radiotherapy- conventional |
Hypofractionated Radiotherapy of 66 Gy in 30 fractions in definitive setting and 60 Gy in 30 fractions in adjuvant setting
Total Duration- 6 weeks |
| Intervention |
Radiotherapy- hypofractionated |
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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1)Age ≥ 18 years
2)ECOG performance status 0 - 2.
3)Patients diagnosed with invasive squamous cell cancer of the head and neck region including lip, oral cavity, nasopharynx, oropharynx, hypopharynx, and larynx
4)Patients with non metastatic cancer, optimally staged with the following:
a)Contrast enhanced CT or MRI scan of the neck and CT of the thorax (or whole body FDG PET-CT scan) for cancer lip, oral cavity, oropharynx, hypopharynx, supraglottis, glottis and subglottis
b)Magnetic Resonance Imaging of the neck and Whole body PET-CT for cancer of nasopharynx
5)Patients who are being treated with curative intent treatment either with radiotherapy or concurrent chemoradiotherapy, neoadjuvant chemotherapy followed by curative radiotherapy or chemoradiotherapy, or primary surgery followed by adjuvant radiotherapy or chemoradiotherapy. Patients must have a histopathological proof of malignancy, such as biopsy or postoperative histopathology report. Biopsies or surgeries done outside must have been reviewed for pathological confirmation and specimen adequacy at the treating institute.
|
|
| ExclusionCriteria |
| Details |
1)Concurrent illness like severe cardiac, renal or hepatic dysfunction and severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety after discussion in MDT
2)Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the average global quality of life score following hypofractionated radiotherapy versus conventional fractionation in head and neck cancer |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the locoregional control at 2 years between the hypofractionated and conventional arm.
To compare acute and late toxicities of hypofractionated radiotherapy with conventional fractionation |
2 years |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sanjoy72@hotmail.com].
- For how long will this data be available start date provided 01-06-2029 and end date provided 01-06-2039?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
HYPORT HN 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
|