Prophylactic para-aortic irradiation vs pelvic radiotherapy in pelvic node-positive carcinoma cervix in the setting of concurrent chemoradiation: a phase II open-label multi centric randomized controlled trial (PRO-PARA)
EMBRACE and Retro EMBRACE studies have shown that excellent local control and pelvic control could be achieved with concurrent chemoradiation and MRI-based brachytherapy in carcinoma cervix. Para-aortic nodal failure rates are higher in pelvic node-positive cases as compared to pelvic node-negative cases as demonstrated in EMBRACE studies. The current study aims to find out the benefit of adding prophylactic para-aortic node irradiation in patients of carcinoma cervix who have involved pelvic nodes on volumetric imaging. This will be a two-arm, parallel group, phase II/III open-label multicenter randomized controlled trial. Patients will be enrolled in a phase II trial where the primary endpoint will be demonstration of reduction in the risk of para-aortic recurrence. If the primary endpoint is met, a phase III trial will be initiated using the same trial design and intervention. Patients in arm A (control arm) will receive pelvic radiotherapy covering the common iliac nodes with Intensity Modulated Radiotherapy (IMRT) to a dose of 45 Gy/25 fractions over 5 weeks. Radiologically involved lymph nodes will be boosted to a dose of 55 Gy/25 fractions with simultaneous integrated boost (SIB). Patients in arm B (Experimental arm) will receive pelvic and elective para-aortic radiotherapy up to the lower border of the renal vein (IMRT) to dose of 45 Gy/25 fractions over 5 weeks. Radiologically involved lymph nodes will be boosted to a dose of 55 Gy/25 fractions with simultaneous integrated boost (SIB). Concurrent chemotherapy with cisplatin 40 mg/m This trial will demonstrate the efficacy of prophylactic para-aortic radiation in pelvic node-positive carcinoma cervix. It also gives an opportunity to standardize and assess the quality-assurance radiotherapy practices in carcinoma cervix across multiple premier institutes of the nation at the same time. Clinical Trial Registry of India (CTRI): CTRI/2023/08/057075. Registered on 30th August 2023.
