NCT04974346

Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer

Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer: a Prospective, Randomized, Multicenter Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 455 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Para-aortic lymph node metastasis is a poor prognostic factor for locally advanced cervical cancer, but false negative diagnosis is easy to occur. The aim of this trial was to investigate whether para-aortic prophylactic radiotherapy improves disease-free survival in patients with positive pelvic lymph nodes below the common iliac artery.

Detailed description

This clinical trial enrolled participants with locally advanced cervical cancer with positive pelvic lymph nodes below the common iliac region diagnosed by Positron emission tomography-computed tomography(PET-CT). Participants should be able to receive concurrent cisplatin chemotherapy. No anti-tumor treatment was given before randomization. Participants will be randomly assigned to two groups. The study group will receive radiotherapy of pelvic and para-aorta, concurrent chemotherapy and brachytherapy, and the control group will receive pelvic radiotherapy, concurrent chemotherapy and brachytherapy.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
RADIATION	Paraaortic prophylactic irradiation and pelvic definitive concurrent chemoradiation	The para-aortic area, from left renal vein level to abdominal aorta bifurcation level，will be prophylactic irradiation. The other intervention is the same as control arm.
RADIATION	Pelvic definitive concurrent chemoradiation	Pelvic definitive concurrent chemoradiation, including external beam radiotherapy, concurrent chemotherapy and brachytherapy.

Timeline

• Start date: 2021-08-02
• Primary completion: 2028-08-01
• Completion: 2030-08-01
• First posted: 2021-07-23
• Last updated: 2022-01-25

Locations

7 sites across 1 country: China