Status:
UNKNOWN
Application of KANG FU PEN in Radical Concurrent Radiotherapy and Chemotherapy for Cervical Cancer to Prevent and Treat Radiation-induced Rectal Injury
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Chinese PLA General Hospital
Conditions:
Cervical Cancer
Radiotherapy Side Effect
Eligibility:
FEMALE
18-65 years
Phase:
PHASE4
Brief Summary
A total of 520 cases will be randomly divided into Kang Fu Pen (liquid dressing) enema intervention group (experimental group) and non-enema intervention group (control group), according to the ratio ...
Detailed 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. Comb...
Eligibility Criteria
Inclusion
- The patient is completely voluntary and has the ability to sign the research informed consent form within 30 days before enrollment;
- Age ≥18 years old and ≤65 years old;
- Pathologically confirmed cervical cancer;
- Those with IB3, IIA2, IIB, IIIA, IIIB, and those with cervical tumor ≥ 4cm or involved parametrial in IIIC1 and IIIC2 (FIGO 2018 staging);
- ECOG score 0-2 points;
- The complete blood count and basal metabolic indexes in the 14 days before enrollment must meet the following requirements: NEUT≥1.5\*10\^9/L, HGB≥80g/L, PLT≥100\*10\^9/L, blood creatinine \< 1.5mg/dl (133umol/L), AST and ALT are within 2 times of the upper limit of normal;
- Those who have had regular bowel movements and had a negative stool routine test + occult blood before enrollment.
Exclusion
- Those who have a history of allergy to superoxide dismutase use;
- Patients with skin and mucous membrane infections, patients with obvious empyema or pelvic inflammatory disease;
- Those who have had chronic colitis, ulcerative colitis, and non-specific proctitis in the past;
- Those who have received cervical cancer surgery (including pelvic or retroperitoneal lymphadenectomy, excluding tumor biopsy), radiotherapy or chemotherapy;
- Those who are expected to be unable to receive brachytherapy, or brachytherapy needs to use tumor elimination, uterine tube inserted alone in one fraction, or template plan;
- Those who need to use fluorouracil or capecitabine or tigio in the concurrent chemotherapy regimen;
- History of other malignant tumors;
- Pregnant or lactating women;
- Accompanied by active infection and fever;
- Other serious diseases that may significantly affect the compliance of clinical trials, such as unstable heart disease, kidney disease, chronic hepatitis, poorly controlled diabetes, and mental illness that require treatment.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT04819685
Start Date
March 1 2021
End Date
March 1 2025
Last Update
March 29 2021
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China