Home » Trials » SLCTR/2025/002
A Randomised Phase 1 proof of concept clinical trial of biphasic fractionation schedules to overcome hypoxia in locally advanced squamous cell carcinoma of the head and neck treated with curative intent primary chemo-radiotherapy
-
SLCTR Registration Number
SLCTR/2025/002
Date of Registration
The date of last modification
Jan 21, 2025
Scientific Title of Trial
A Randomised Phase 1 proof of concept clinical trial of biphasic fractionation schedules to overcome hypoxia in locally advanced squamous cell carcinoma of the head and neck treated with curative intent primary chemo-radiotherapy
Public Title of Trial
A randomised phase 1 proof-of-concept clinical trial evaluating the feasibility of delivering biphasic fractionation schedules compared to standard fractionation to overcome hypoxia in patients with locally advanced squamous cell carcinoma of the head and neck treated with curative intent chemo-radiotherapy.
Disease or Health Condition(s) Studied
Squamous cell carcinoma of the head and neck
Scientific Acronym
HYPOCON
Public Acronym
HYPOCON
Brief title
A phase 1 trial of biphasic fractionation to overcome hypoxia in head and neck squamous cell carcinoma.
Universal Trial Number
U1111-1315-2653
Any other number(s) assigned to the trial and issuing authority
P-118-08-2024 (ERC, Faculty of Medicine, University of Kelaniya)
What is the research question being addressed?
Is it feasible to deliver a biphasic fractionation regimen, consisting of hyperfractionation followed by hypofractionation, compared to standard fractionantion in patients with squamous cell carcinoma of the head and neck treated with curative intent radiotherapy?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 1
Intervention(s) planned
Eligible patients presenting to the oncology units of the Apeksha Hospital, Teaching Hospital Batticaloa and District General Hospital of Hambantota, Sri Lanka, will be enrolled to the study.
Recruitment of participants will be done by the site investigators and their research teams. Following consent, participants will be allocated to either the control or experimental group, as defined below, with an allocation ratio of 1:1 using random allocation sequence generated by the R software ‘blockrand’ package. Randomisation will be stratified by trial centre.
The investigators and participants will know the treatment allocation. The control group will be treated to a dose of 55 Gy in 20 fractions over 4 weeks. The experimental group will be treated with the following fractionation schedule: Phase 1: 40 Gy in 20 fractions over 3 weeks and 3 days followed by Phase 2: 15 Gy in 3 fractions over 3 days. Participants will be followed up every month during the first year after completing treatment and every 2 months during the second year of treatment. Patients will continue routine follow-up as per institutional protocol thereafter.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Proportion of patients who completed all treatment fractions as outlined in the protocol |
[ At 24 months. ] |
Secondary outcome(s)
|
1.
The rate of toxicities (classified per CTCAE version 5.0.) that are possibly, probably and definitely related to radiotherapy. |
[ Ongoing, up to 24 months ] |
|
2.
Tumor response rate (complete response, partial response, stable disease, or progressive disease) based on clinical or radiological assessment. Complete response: Defined as complete radiological response of the primary tumour and lymph nodes on Positron emission tomography / computed tomography (PET/CT) or Contrast enhanced computed tomography (CECT) imaging. Partial response: Defined as more than 50% reduction of tumour volume in the primary tumour and lymph nodes as per the RECIST criteria. No response: Defined as less than 50% reduction of tumour volume in the primary tumour and lymph nodes as per RECIST criteria. Progressive disease: Defined as an increase of 20% of tumour volume in the primary tumour and/or lymph nodes or the emergence of new nodal or systemic metastatic lesions. |
[ Ongoing, up to 24 months ] |
|
3.
Time to disease progression or death from randomisation. Disease recurrence in either the primary tumour, lymph nodes or systemic sites will be considered as an event determining disease progression. Partial response, no response or progressive disease shall be considered as disease progression with time set to end of completion of radiotherapy. |
[ Ongoing, up to 24 months ] |
|
4.
Time from the start of treatment to death from any cause |
[ Ongoing, up to 24 months ] |
Target number/sample size
46 (23 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2025-02-17
Anticipated end date
2029-12-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
The Sri Lanka Cancer Research Group Sri Lanka College of Oncologists.
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2024-09-10
Approval number
P-118-08-2024
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | P.O Box 6, Thalagolla Road, Ragama, Sri Lanka |
| Telephone: | +94 11 2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Nuradh Joseph,
Consultant Clinical Oncologist
District General Hospital, Hambantota
+94777745544
nuradh@gmail.com
Contact Person for Public Queries
Dr. Nuradh Joseph,
Consultant Clinical Oncologist
District General Hospital, Hambantota
+94777745544
nuradh@gmail.com
Primary study sponsor/organization
The Sri Lanka Cancer Research Group
Sri Lanka College of Oncologists
National Cancer Institute, Maharagama,
Sri Lanka
slconcology@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
