A Prospective Randomized Comparative Study Between 60 Gy vs. 50 Gy Dose Radiotherapy with Concurrent Chemotherapy in Locally Advanced Unresectable Oesophageal Cancer; tertiary rural Indian cancer centre experience

Abstract

Abstract Purpose- To evaluate and compare the safety and efficacy of 60 Gy versus 50 Gy dose radiotherapy with concurrent chemotherapy in locally advanced unresectable oesophageal cancer. Methods- Study design was prospective, randomized and comparative. 60 Patients (30 patients in each arm) with histologically proven locally advanced unresectable oesophageal carcinoma and with good balance in observed co-variables were enrolled. Total radiation dose of 60 Gy was given in one arm while 50 Gy in another arm. Weekly CCRT was given till radiotherapy treatment completion in both the arms with paclitaxel 75 mg/m2 and carboplatin AUC 2. Statistical analysis was done using SPSS version 2.0. At 4 weeks of completion of treatment and after 6 months follow-up, response was assessed using RECIST (1.1) criteria. Results- In 60 Gy dose arm, 76.66% patients and in 50 Gy arm, 70% patients achieved CR but the difference was statistically non- significant (p= 0.559). After 6 months of median follow up, 60% patients in 60 Gy arm and 50% in 50 Gy arm had CR whereas 30% patients in 60 Gy arm and 40% in 50 Gy arm had LRF. There were no statistically significant differences between the two arms in leucopenia (p=0.576), nephrotoxicity (p=1.0), radiation dermatitis (p=0.615), vomiting (p=0.921) and diarrhoea (p=1.0). Conclusion- 60 Gy dose radiotherapy with concurrent chemotherapy can be used feasibly and safely with only a few manageable side effects and with favourable benefit-risk profile, especially in terms of local tumour control. However, to validate this conclusion, large sample size and longer follow-up will be required.