Application of KANG FU PEN in Radical Concurrent Radiotherapy and Chemotherapy for Cervical Cancer to Prevent and Treat Radiation-induced Rectal Injury
Last updated on July 2021Recruitment
- 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