Original Research ArticleInternational Journal of Clinical Trials

Publication:
Hypofractionated radiotherapy with weekly paclitaxel and carboplatin versus conventional fractionation radiotherapy with weekly cisplatin in carcinoma of the larynx and hypopharynx for response and toxicity assessment

Int J Clin Trials. 2026;13(1):23-29.DOI10.18203/2349-3259.ijct20260043

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Abstract

Background Conventional fractionated radiotherapy (CFRT) with weekly cisplatin is the standard of care for locally advanced laryngeal and hypopharyngeal carcinoma but is often limited by significant toxicity. This study evaluates hypofractionated radiotherapy (HFRT) combined with weekly low-dose paclitaxel and carboplatin as a more tolerable alternative. Objective of the study was to compare the tumor response and toxicity profiles of HFRT plus paclitaxel/carboplatin versus CFRT plus cisplatin.

Methods Sixty-four patients with stage III–IVB carcinoma were randomized into two arms. Arm 1 received HFRT (63 Gy in 28 fractions) with weekly paclitaxel (30 mg/m²) and carboplatin (AUC 1.5). Arm 2 received CFRT (70 Gy in 35 fractions) with weekly cisplatin (30 mg/m²). Response was assessed via RECIST 1.1; toxicities were graded using RTOG/CTCAE criteria.

Results At 6 weeks post-treatment, the complete response (CR) rate was 71.9% in arm 1 and 68.8% in arm 2. Arm 1 demonstrated a significantly improved safety profile, with lower rates of grade 3 mucositis (28.1% versus 43.8%) and grade 3 leukopenia (15.6% versus 28.1%). Additionally, grade 2 skin reactions (25% versus 37.5%) and nausea/vomiting (31.3% versus 53.1%) were less frequent in arm 1, leading to higher treatment compliance.

Conclusions HFRT with weekly low-dose paclitaxel/carboplatin offers non-inferior efficacy and superior tolerability compared to standard CFRT. It is a viable therapeutic strategy for elderly or renal-compromised patients and in resource- constrained settings.

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Affiliations

  1. Department of Radiation Oncology, Government Medical College and Cancer Hospital, Chatrapati Sambhaji Nagar, Aurangabad, Maharashtra, India

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