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Clinical Trials/ITMCTR2000004198
ITMCTR2000004198
Recruiting
Phase 1

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

Guangdong Provincial Hospital of Traditional Chinese Medicine (the Second Affiliated Hospital of Guangzhou University of traditional Chinese Medicine)0 sitesTBD

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Radiation proctitis
Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine (the Second Affiliated Hospital of Guangzhou University of traditional Chinese Medicine)
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional study
Sex
Female

Investigators

Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine (the Second Affiliated Hospital of Guangzhou University of traditional Chinese Medicine)

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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