Comparison of Conventional Palliative Radiotherapy Fractionation Schedule with Quad Shot Regimen in Locally Advanced Head and Neck Cancer Patients: A Randomised Clinical Trial

Introduction: Head and Neck Cancer (HNC) accounts for 14.3% of all cancers in India and 4.8% of all cancers worldwide. In India, the most common sites are the lip and oral cavity (>80%), which are more prevalent in men than in women. Histologically, most cases are Squamous Cell Carcinomas (SCC). The majority of patients present with locally advanced stages, where surgery and definitive chemoradiation therapy are not possible and palliative Radiotherapy (RT) is considered a treatment option for better symptomatic relief and improved Quality of Life (QoL). The Quad Shot (QS) palliative regimen has shortened treatment time, reduced toxicity and increased compliance. Aim: To compare the QS regimen administered over two consecutive days versus the Conventional Palliative Regimen in the treatment of locally advanced HNC, in terms of treatment response, acute toxicities and QoL. Materials and Methods: In this prospective randomised clinical trial conducted from May 2023 to July 2024 in the Department of Radiation Oncology at King George's Medical University (KGMU), Lucknow, Uttar Pradesh, India, patients with biopsyproven locally advanced carcinoma of the head and neck were recruited, with a sample size of 50 in each of the study Group B and control Group A arms. Patients in the control arm received 30 Gray (Gy) in 10 fractions, 5 fractions per week over two weeks (Conventional palliative arm). In the study arm, patients received 14 Gy in 4 fractions delivered in two daily sessions, six to eight hours apart, for two consecutive days over three cycles (QS arm). The Response Evaluation Criteria in Solid Tumours (RECIST) Criteria 1.1 was used to assess the tumour response objectively three months post-RT. Health-related QoL was assessed using questionnaires developed by the European Organisation for Research and Treatment of Cancer (EORTC), specifically the EORTC Quality of Life Questionnaire (QLQ). Continuous data were compared using the t-test for nominal data and the Mann-Whitney U test was used otherwise. Results: The mean age was 39.66±12.05 years in Group A and 42.76±11.65 years in Group B. The QS and conventional palliative arms each had 47 and 49 patients recruited, respectively. The QS arm exhibited fewer instances of skin toxicity, with 25 (53.2%) experiencing Grade I and 7 (14.9%) experiencing Grade II toxicity, compared to the conventional palliative arm, where 30 (61.2%) had Grade I and 12 (24.5%) had Grade II toxicity. Mucositis in the QS arm included 22 (46.9%) cases, with 14 (29.7%) classified as Grade I and Grade II, whereas the conventional arm had 12 (24.5%) Grade I cases, 29 (59.5%) Grade II cases and 3 (6.1%) Grade III cases. The treatment response, in terms of partial and stable disease combined, was observed in 61.2% of the conventional arm compared to 78.7% in the QS arm. QoL was reported to be better in the QS regimen post-treatment. Conclusion: Given the total number of patients recruited, the QS arm, with its shorter treatment time, demonstrated better benefits in terms of reduced toxicities and improved treatment response, as well as enhanced QoL compared to the conventional palliative arm.