Sri Lanka’s First Oncology Proof-of-Concept Clinical Trial

Sri Lanka is taking a step forward in cancer research with its investigator-initiated oncology clinical trial. Led by Dr. Nuradh Joseph, Consultant Clinical Oncologist, in collaboration with the Sri Lanka College of Oncologists (SLCO), this trial focuses on improving treatment for patients with locally advanced squamous cell carcinoma of the head and neck.

The study, titled “A Randomised 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,” aims to test a new radiation therapy approach. The goal is to overcome hypoxia (low oxygen levels in tumors), which can make cancer cells resistant to treatment. Studies have shown that hypoxic tumors require higher radiation doses to achieve control, often exceeding the tolerance of surrounding healthy tissues.

The trial investigates biphasic fractionation schedule, which combines hyperfractionation: delivering smaller, more frequent doses of radiation and hypofractionation: administering higher doses of radiation in fewer sessions to address hypoxia in tumors. This study builds upon the previous modeling study by Dr. Nuradh, which demonstrated an increase in the tumor’s effective radiation dose by 3.5–8 Gy when delivered in standard 2 Gy fractions without increasing toxicity https://academic.oup.com/bjr/article/93/1112/20190250/7448890 V.

The Clinical Trials Unit, University of Kelaniya and RemediumOne will be managing and monitoring the trial, overseeing data collection and data analysis.

Trial Design

A randomized multi-centre proof-of-concept trial. Patients will be divided into two groups:

Control Group: Receives standard radiation therapy (55 Gy in 20 fractions over 4 weeks).
Experimental Group: Receives a biphasic fractionation schedule—40 Gy in 20 fractions over 3 weeks and 3 days, followed by 15 Gy in 3 fractions.

Gy is the SI unit of radiation dose

The primary objective is to determine if this new approach is feasible and effective in improving outcomes for patients.

The trial aims to recruit 46 patients over 2 years. It will be conducted at multiple centers across Sri Lanka:

Apeksha Hospital, Maharagama (Dr. Nadarajah Jeyakumaran)

Teaching Hospital, Batticaloa (Dr. Ahamed Iqbal)

District General Hospital, Matara (Dr. Nuradh Joseph)

District General Hospital, Hambantota (Dr. AsankaGamage)

The trial is currently underway with 3 patients receiving the treatment at the Apeksha Hospital, Maharagama and Teaching Hospital, Batticaloa.

Stay tuned for updates on this cancer clinical trial.