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Background <p>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.</p> Methods <p>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&#xa0;Gy/25 fractions over 5 weeks. Radiologically involved lymph nodes will be boosted to a dose of 55&#xa0;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&#xa0;Gy/25 fractions over 5 weeks. Radiologically involved lymph nodes will be boosted to a dose of 55&#xa0;Gy/25 fractions with simultaneous integrated boost (SIB). Concurrent chemotherapy with cisplatin 40&#xa0;mg/m<sup>2</sup> weekly will be given during external beam radiotherapy in both the arms. After completion of concurrent chemoradiation, high dose rate (HDR) intracavitary or intracavitary + interstitial brachytherapy will be performed in both the arms.</p> Discussion <p>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.</p> Trial registration <p>Clinical Trial Registry of India (CTRI): CTRI/2023/08/057075. Registered on 30th August 2023.</p>

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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)

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  • 发表日期：

    2026年3月7日

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  • Tapesh Bhattacharyya,
  • Bhavana Rai,
  • Santam Chakraborty,
  • Srinivas GY,
  • Shirley Lewis Christabel,
  • Pritanjali Singh,
  • Anurupa Mahata,
  • Samar Mandal,
  • Gaurav Trivedi,
  • Sreekripa Rao,
  • Ankita Mehta,
  • Oindrila Roychowdhury,
  • Sougata Maity

摘要

Background

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.

Methods

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/m2 weekly will be given during external beam radiotherapy in both the arms. After completion of concurrent chemoradiation, high dose rate (HDR) intracavitary or intracavitary + interstitial brachytherapy will be performed in both the arms.

Discussion

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.

Trial registration

Clinical Trial Registry of India (CTRI): CTRI/2023/08/057075. Registered on 30th August 2023.