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.

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2025/002

Enrollment

Unknown

Registered

2025-01-21

Start date

2025-02-17

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Squamous cell carcinoma of the head and neck

Interventions

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. Recrui

Eligibility

Inclusion criteria

Inclusion criteria: 1. Males and females age more than 18 years and less than 70 years of age 2. Eastern Cooperative Oncology Group (ECOG) performance status 0 and 1 3. Squamous cell carcinoma of the oropharynx or hypopharynx or larynx or supraglottis 4. Tumour stage should be N2 or higher 5. Histopathological or radiological evidence of tumour necrosis. 6. Suitable for treatment with radiosensitising chemotherapy with intravenous cisplatin: 6.1 Estimated Glomerular Filtration Rate more than 50 ml/min 6.2 Absolute Neutrophil Count more than 1500 cells/mm3 6.3 Platelet Count more than 100,000 cells/mm3 6.4 Haemoglobin more than 10g/dl (Use of transfusions to achieve target Haemoglobin is permitted)

Exclusion criteria

Exclusion criteria: 1. Patients with cervical lymph node metastases with no identifiable primary tumour 2. Previous history of malignancy 3. Synchronous separate primary tumour outside the oropharynx, hypopharynx, larynx or supraglottis 4. Treatment with curative-intent surgery 5. Presence of systemic metastases 6. Pregnancy

Design outcomes

Primary

Measure	Time frame
Proportion of patients who completed all treatment fractions as outlined in the protocol [At 24 months.]	—

Secondary

Measure	Time frame
The rate of toxicities (classified per CTCAE version 5.0.) that are possibly, probably and definitely related to radiotherapy. [Ongoing, up to 24 months] 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] 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] Time from the start of treatment to death from any cause [Ongoing, up to 24 months]	—

Measure

Time frame

The rate of toxicities (classified per CTCAE version 5.0.) that are possibly, probably and definitely related to radiotherapy. [Ongoing, up to 24 months] 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] 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] Time from the start of treatment to death from any cause [Ongoing, up to 24 months]

—

Countries

Sri Lanka

Contacts

Public ContactDr. Nuradh Joseph,

Consultant Clinical Oncologist

nuradh@gmail.com

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 10, 2026