Pelvic RT Versus Prophylactic Extended-field RT in Patients With Cervical Cancer

Summary

To investigate the value of prophylactic extended-field irradiation (EFI), we conduct a randomized clinical trial to compare the efficacy and toxicity of pelvic irradiation and prophylactic EFI in selected patients with cervical cancer treated with definitive concurrent chemoradiotherapy. External beam radiation therapy is delivered with intensity-modulated radiation therapy (IMRT).

Conditions

• Uterine Cervical Neoplasms

Interventions

RADIATION

Prophylactic extended-field Irradiation

CTV covers pelvis and para-aortic lymph nodes region.

RADIATION

Pelvic irradiation

CTV covers pelvis.

RADIATION

Intracavitary brachytherapy

The total dose delivered to point A or high-risk CTV is ≥80Gy. For patients with larger-volume cervical tumor, the total dose is ≥85Gy.

DRUG

Concurrent chemotherapy

Cisplatin based concurrent chemotherapy, including cisplatin as a single agent or cisplatin plus Paclitaxel.

Sponsors & Collaborators

• Peking University First Hospital

  collaborator OTHER

• Cangzhou Central Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• Gansu Wuwei Tumor Hospital

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• Harbin Medical University Third Affiliated Hospital

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Guizhou Provincial People's Hospital

  collaborator OTHER

• Second Hospital of Jilin University

  collaborator OTHER

• China-Japan Union Hospital, Jilin University

  collaborator OTHER

• Jilin Provincial Tumor Hospital

  collaborator OTHER

• Jiangsu Cancer Institute & Hospital

  collaborator OTHER

• 940 Hospital of the People's Liberation Army Joint Logistic Support Force

  collaborator OTHER

• General Hospital of Benxi Iron & Steel Industry Group

  collaborator UNKNOWN

• The Affiliated Hospital of Inner Mongolia Medical University

  collaborator OTHER

• General Hospital of Ningxia Medical University

  collaborator OTHER

• Beijing Obstetrics and Gynecology Hospital

  collaborator OTHER

• Tangshan People's Hospital

  collaborator OTHER

• Zhongnan Hospital

  collaborator OTHER

• Second Affiliated Hospital of Xi'an Jiaotong University

  collaborator OTHER

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• The Affiliated Tumor Hospital of Xinjiang Medical University

  collaborator UNKNOWN

• Zhejiang Cancer Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Affiliated Cancer Hospital of Zhengzhou University

  collaborator UNKNOWN

• Seventh Medical Center of PLA Army General Hospital

  collaborator OTHER

• Shengjing Hospital

  collaborator OTHER

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• Xi'an Gaoxin Hospital

  collaborator OTHER

• West China Second University Hospital

  collaborator OTHER

• The Forth Affiliated Hospital of Guangxi Medical University

  collaborator UNKNOWN

• Peking Union Medical College Hospital

  lead OTHER

Principal Investigators

• Ke Hu · Peking Union Medical College Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-17

Primary Completion

2022-06-01

Completion

2025-06-01

Countries

• China

Study Locations