Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Cervical Cancer
  • Radiotherapy Side Effect
  • Radiotherapy; Complications
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Only males

Description

All patients are planned to receive radical concurrent chemoradiotherapy. Intensity modulated radiotherapy (IMRT) will be used for external irradiation, with a dose of 45-50.4Gy /25-28 fractions. Combined three-dimensional intracavitary/interstitial (IC/IS) brachytherapy was applied. The preferred d...

All patients are planned to receive radical concurrent chemoradiotherapy. Intensity modulated radiotherapy (IMRT) will be used for external irradiation, with a dose of 45-50.4Gy /25-28 fractions. Combined three-dimensional intracavitary/interstitial (IC/IS) brachytherapy was applied. The preferred dose fraction plan is 6Gy*5 fractions, or 7Gy*4 fractions. Whether to adopt supplement radiotherapy can be decided by the tumor regression. Cisplatin 40 mg/m2 is recommended as the first choice for concurrent chemotherapy, and TP or TC can also be considered. Single-drug weekly therapy should be completed for at least 3 cycles, and combined 3-week regimen should be completed for at least 1 cycle. Experimental group: from three days before radiotherapy to one week after radiotherapy, Kang Fu Pen (recombinant human superoxide dismutase) retention enema, 50ml/ time, once every other day. When rectal mucosa II degree reactions (NCI-CTCAE 5.0) occur, it is changed to 1 day/time until 1 week after mucosal remission. Control group: 3 days before radiotherapy to the end of radiotherapy, no drug retention enema was used.

Tracking Information

NCT #
NCT04819685
Collaborators
  • Peking University Third Hospital
  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Chinese PLA General Hospital
  • Beijing Cancer Hospital
  • Jiangsu Cancer Institute & Hospital
  • Zhejiang Cancer Hospital
  • Sichuan Cancer Hospital and Research Institute
  • Sun Yat-sen University
  • Xiangya Hospital of Central South University
  • Jilin Provincial Tumor Hospital
  • Henan Cancer Hospital
  • Fudan University
  • Guizhou Cancer Hospital (The Affiliated Cancer Hospital of Guizhou Medical University)
  • Shandong Cancer Hospital
  • Xijing Hospital Attached Air Force Medical University
Investigators
Not Provided