Hypofractionated Versus Conventional Fractionated Radiotherapy with concomitant Chemotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma- a single institutional Randomised Controlled Trial

In India, according to GLOBOCAN 2022, cancers of Lip and Oral Cavity are the 2nd most

prevalent. Similarly, cancer of larynx stands 13th in rank in distribution of new cases and in

death due to cancers in 2022.

Whereas, Hypopharynx, Oropharynx and Nasopharynx stand on 15th, 16th, 27th rank

respectively in distribution of new cancer cases in 2022. Death due to these cancers hold rank

20th, 17th and 25th respectively for Hypopharynx, Oropharynx and Nasopharynx. Tobacco

smoking and chewing is commonest known etiological factor.

Management of loco-regionally advanced head and neck squamous cell carcinoma with

curative intent has evolved considerably over time with active research, volumes of literature,

large randomized control trials and meta-analyses supporting evidence-based guidelines [3].

Attempts to cure such patients with aggressive multimodality treatment or intense radiotherapy

regimens have not succeeded till date. The 5-year survival even with aggressive multimodal

approach is reported to be <20%, with a median survival less than 12 months.

Strategies that modulate the biological response of tumours or normal tissues to radiation

include altered fractionation schedules, combined modality treatments using chemotherapeutic

agents and more recently biological agents targeting molecular processes and signalling

pathways. Altered fractionation schedules seek to improve the therapeutic ratio between

tumour cell kill and normal tissue damage by exploiting the dissociation between acute and

late radiation effects.There is no doubt that hypofractionation offer potential benefits to the

patients and economy of health system, but their clinical implementation should not be at the

expense of a lower likelihood of tumour control or a greater adverse effect on normal

tissue.[4][5] The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic

has developed an interest in hypofractionation radiotherapy (HFRT) in few malignancies,

including locally advanced head and neck cancer.

Furthermore, besides the evident logistical advantages, radiobiological modelling suggests that

3.0 Gy per fraction or accelerated hyperfractionation schedules (1.8 Gy per fraction with two

fractions per weekday) are considerably more effective for head and neck tumour control and

for the reduction in late effects than the standard 2Gy fractionation.

Finding a hypofractionated radiotherapy schedule along with concurrent chemotherapy with

radical intent or with the aim of a prolonged local control with equivalent toxicity as compared

to standard regimen would be significantly advantageous in this group of patients. The External

Beam Radiation most commonly given to patients with Head and Neck cancer not intervening

into any surgery is 70 Gy in 35 fractions over 7weeks. The treatment continues for at least 7

weeks. Treatment with Radiotherapy develops some acute effects like mucositis, radiation

dermatitis, xerostomia, viscous mucous production, dysphagia, dyspnoea, dysgeusia, pain due

to inflammatory reaction and the production of reactive oxygen species causing damage to

mucosa and soft tissue

The aim of this study is to identify whether Hypofractionated (55 Gy, 20F, 5F/wk. over 4

weeks) with weekly cisplatin shows similar results to Conventional (70 Gy, 35F, 5F/wk. over

7 weeks) with weekly cisplatin with respect to both loco-regional tumour control and Grade 3+

late adverse events