Application of KANG FU PEN in Radical Concurrent Radiotherapy and Chemotherapy for Cervical Cancer to Prevent and Treat Radiation-induced Rectal Injury

• Status: Recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: Female

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 of 1:1.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborators: Beijing Cancer Hospital; Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Chinese PLA General Hospital; Fudan University; Guizhou Cancer Hospital (The Affiliated Cancer Hospital of Guizhou Medical University); Henan Cancer Hospital; Jiangsu Cancer Institute & Hospital; Jilin Provincial Tumor Hospital; Peking University Third Hospital; Shandong Cancer Hospital; Sichuan Cancer Hospital and Research Institute; Sun Yat-sen University; Xiangya Hospital of Central South University; Xijing Hospital Attached Air Force Medical University; Zhejiang Cancer Hospital

Criteria

Inclusion Criteria:

1. The patient is completely voluntary and has the ability to sign the research informed consent form within 30 days before enrollment;

2. Age ≥18 years old and ≤65 years old;

3. Pathologically confirmed cervical cancer;

4. Those with IB3, IIA2, IIB, IIIA, IIIB, and those with cervical tumor ≥ 4cm or involved parametrial in IIIC1 and IIIC2 (FIGO 2018 staging);

5. ECOG score 0-2 points;

6. 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;

7. Those who have had regular bowel movements and had a negative stool routine test + occult blood before enrollment.

Exclusion Criteria:

1. Those who have a history of allergy to superoxide dismutase use;

2. Patients with skin and mucous membrane infections, patients with obvious empyema or pelvic inflammatory disease;

3. Those who have had chronic colitis, ulcerative colitis, and non-specific proctitis in the past;

4. Those who have received cervical cancer surgery (including pelvic or retroperitoneal lymphadenectomy, excluding tumor biopsy), radiotherapy or chemotherapy;

5. 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;

6. Those who need to use fluorouracil or capecitabine or tigio in the concurrent chemotherapy regimen;

7. History of other malignant tumors;

8. Pregnant or lactating women;

9. Accompanied by active infection and fever;

10. 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.