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A multi-center, prospective clinical trial for KUSHEN Ningjiaos was inserted into rectum to reduce the rate of radiation proctitis in three-dimensional brachytherapy of cervical cancer

A multi-center, prospective clinical trial for KUSHEN Ningjiaos was inserted into rectum to reduce the rate of radiation proctitis in three-dimensional brachytherapy of cervical cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900021631
Enrollment
Unknown
Registered
2019-03-02
Start date
2018-06-20
Completion date
Unknown
Last updated
2019-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiation proctitis

Interventions

2 Groups:with or without the insertion of Kushen Ningjiaos

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. The result of pathologically confirmed cervical carcinoma (FIGO: a stage of I-IV); 2. Had undergone EBRT prior to brachytherapy and did not undergo a hysterectomy; 3. If the patient was treated during the fertile window, she took contraceptive measures during the study; 4. KPS score =60; 5. All patients gave written informed consent, according to the Helsinki Declaration; 6. Aged from 18 to 80 years old.

Exclusion criteria

Exclusion criteria: 1. Patients with other malignant (non-gynecological tumors) tumors before entering the group; 2. had undergone hysterectomy, laparoscopic staging surgery; 3. At the same time merge other gynecological tumors.

Design outcomes

Primary

MeasureTime frame
The rate of chronic radiation proctitis;The whole rectal wall volume of radiation dose;The anterior rectal wall volume of radiation dose;The posterior rectal wall volume of radiation dose;

Secondary

MeasureTime frame
The D1cc of the whole rectal wall;The D1cc of the anterior rectal wall;The D1cc of the pasterior rectal wall;The D2cc of the whole rectal wall;The D2cc of the anterior rectal wall;The D2cc of the posterior rectal wall;The distance from the posterior rectal wall to CTV;The incidence of chronic radiation cystitis;

Countries

China

Contacts

Public ContactGao Lei

Guangdong Provincial Hospital of Chinese Medicine

gzgaolei@126.com+86 15920999579

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 20, 2026