A multi-center, prospective clinical trial for KUSHEN Ningjiaos was inserted into rectum to reduce the rate of radiation proctitis in re-irradiation of patients with local recurrence of cervical cancer

Phase 1

Recruiting

• Conditions: Radiation proctitis

• Registration Number: ITMCTR2000004198
• Lead Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine (the Second Affiliated Hospital of Guangzhou University of traditional Chinese Medicine)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients who have received radical radiotherapy or hysterectomy plus adjuvant radiotherapy after pathological diagnosis of cervical cancer;
2. Patients with local recurrence of cervical cancer 3 months after the end of treatment were confirmed by pathology and imaging;
3. Patients who received external pelvic radiation therapy (EBRT) and intracavitary brachytherapy (BT) were treated with radiotherapy;
4. Patients with chronic radiation proctitis before radiotherapy and the severity should be less than or equal to grade I.
5. Patients with KPS score >= 60;
6. Patients who voluntarily participated in the trial and signed informed consent in writing;
7. Patients aged 18-75 years.

Exclusion Criteria

1. Patients with other malignant tumors before enrollment;
2. Those patients whose first treatment after diagnosis of cervical cancer does not include radiotherapy;
3. Patients with distant recurrence at the same time;
4. Patients with serious organic diseases such as heart, lung, liver and kidney;
5. Patients with severe radiation proctitis (acute grade >= 3 or chronic grade = III) in the first radiotherapy.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The whole rectal wall volume of radiation dose;The rate of acute radiation proctitis;The posterior rectal wall volume of radiation dose;High dose equivalent biological dose to the rectal wall (EQD2);The anterior rectal wall volume of radiation dose;

Secondary Outcome Measures

Name	Time	Method
Incidence of severe acute radiation proctitis (>=Grade 3);Local control rates of recurrent tumors;