Skip to content

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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000004198
Enrollment
Unknown
Registered
2020-12-26
Start date
2020-12-23
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Radiation proctitis

Interventions

Sponsors

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

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Incidence of severe acute radiation proctitis (>=Grade 3);Local control rates of recurrent tumors;

Countries

China

Contacts

Public ContactGao Lei

Guangzhou University of traditional Chinese Medicine

gzgaolei@126.com+86 15920999579

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026