Actively Recruiting

Phase 3
Age: 18Years - 75Years
FEMALE
NCT04974346

Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer

Led by Zhejiang Cancer Hospital · Updated on 2022-01-25

455

Participants Needed

7

Research Sites

469 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients voluntarily participate and sign informed consent
  • Female aged 18 to 75 years
  • Diagnosed with cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
  • FIGO 2009 stage IB2 to IIIA with positive pelvic lymph nodes and negative common iliac and para-aortic nodes by PET-CT
  • Eligible for cisplatin chemotherapy
  • ECOG performance status 0 or 1
  • Expected survival longer than 6 months
  • Women of childbearing age must have a negative pregnancy test within 7 days before enrollment and agree to use contraception during the study
  • Able to comply with trial protocol as judged by the researcher
Not Eligible

You will not qualify if you...

  • Uncontrolled severe infections
  • Other malignant tumors requiring treatment or newly diagnosed within 5 years
  • Prior anti-tumor treatment received
  • Liver cirrhosis, decompensated liver disease, chronic kidney failure
  • History of immunodeficiency including HIV
  • Recent myocardial infarction, severe arrhythmia, or moderate to severe congestive heart failure
  • Previous pelvic artery embolization
  • Prior pelvic radiotherapy for malignancy
  • History of severe allergic reaction to platinum chemotherapy
  • Conditions requiring liver or kidney damaging drugs during treatment
  • Unable to understand study or unwilling to consent
  • Other serious diseases or conditions risking safety or study completion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China, 310022

Actively Recruiting

2

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

Active, Not Recruiting

3

Jinhua Municipal Central Hospital Medical Group

Jinhua, China

Active, Not Recruiting

4

Lishui People's Hospital

Lishui, China

Active, Not Recruiting

5

Ningbo First Hospital

Ningbo, China

Active, Not Recruiting

6

Taizhou Central Hospiatl

Taizhou, China

Active, Not Recruiting

7

Chongqing University Three Gorges Hospital

Wanzhou, China

Active, Not Recruiting

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Research Team

X

Xiang Zhang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer | DecenTrialz