RecruitingPhase 3NCT04974346

Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer

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


Sponsor

Zhejiang Cancer Hospital

Enrollment

455 participants

Start Date

Aug 2, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding preventive radiation to the lymph nodes around the aorta (the major abdominal artery) reduces the risk of cancer spreading there in women with locally advanced cervical cancer who have positive pelvic lymph nodes but no spread to the para-aortic area. **You may be eligible if...** - You are a woman between 18 and 75 years old - You have cervical cancer (squamous cell, adenocarcinoma, or adenosquamous type) - Your cancer is stage IB2–IVA with positive pelvic lymph nodes and no para-aortic lymph node involvement (confirmed by PET-CT) - You are medically fit to receive cisplatin chemotherapy - You have a good performance status (ECOG 0–1) and expected survival over 6 months - Pregnancy test is negative if you are of childbearing age **You may NOT be eligible if...** - Cancer has already spread to the para-aortic or common iliac lymph nodes - You cannot tolerate cisplatin chemotherapy - You have stage IVB (distant metastatic) cervical cancer - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONParaaortic 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.

RADIATIONPelvic definitive concurrent chemoradiation

Pelvic definitive concurrent chemoradiation, including external beam radiotherapy, concurrent chemotherapy and brachytherapy.


Locations(7)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

Jinhua Municipal Central Hospital Medical Group

Jinhua, China

Lishui People's Hospital

Lishui, China

Ningbo First Hospital

Ningbo, China

Taizhou Central Hospiatl

Taizhou, China

Chongqing University Three Gorges Hospital

Wanzhou, China

View Full Details on ClinicalTrials.gov

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NCT04974346


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