Cervical Cancer Clinical Trial
Official title:
Application of KANG FU PEN (Protective Irrigation Solution Against Rays) in Radical Concurrent Radiotherapy and Chemotherapy for Cervical Cancer to Prevent and Treat Radiation-induced Rectal Injury:a Multicenter, Prospective, Randomized Trail
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.
Status | Recruiting |
Enrollment | 520 |
Est. completion date | March 1, 2025 |
Est. primary completion date | March 1, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Peking Union Medical College Hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital | 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 |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Degree of rectal mucosal injury caused by acute radiation | the incidence of Vienna rectoscopy score =2 within 1 week after radiotherapy. Vienna rectoscopy score was used. | Within 1 week after radiotherapy | |
Secondary | Degree of rectal injury caused by chronic radiation | incidence of RTOG score =2 at 3 to 24 months after radiotherapy. If the RTOG score =2 at 3 to 24 months after radiotherapy, rectoscopy will be used to evaluate the degree. If the RTOG score is 0 or 1, clinical classification is enough. | 3 to 24 months after radiotherapy | |
Secondary | Quality of life score | EORTC QLQ-C30 (V3.0) was used to score quality of life before, during, and after radiotherapy. | 3 to 24 months after radiotherapy | |
Secondary | overall survival (OS) | Overall survival (OS) is defined as the time interval from randomization to death from any cause or, if no death, to the last follow-up. | 3 years after radiotherapy | |
Secondary | disease-progression-free survival (PFS) | Progression-free survival (PFS) is defined as the time between randomization and the occurrence of local or regional recurrence, or distant metastasis, or death from any cause, based on the time of the first event and, if none of these events occurred, to the last follow-up. | 3 years after radiotherapy |
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