application of kang fu pen in radical concurrent radiotherapy and chemotherapy for cervical cancer to prevent and treat radiation-induced rectal injury

Conditions: Cervical Cancer; Radiotherapy Side Effect; Radiotherapy; Complications

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.

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. combined three-dimensional intracavitary/interstitial (ic/is) brachytherapy was applied. the preferred dose fraction plan is 6gy\*5 fractions, or 7gy\*4 fractions. whether to adopt supplement radiotherapy can be decided by the tumor regression. cisplatin 40 mg/m2 is recommended as the first choice for concurrent chemotherapy, and tp or tc can also be considered. single-drug weekly therapy should be completed for at least 3 cycles, and combined 3-week regimen should be completed for at least 1 cycle. experimental group: from three days before radiotherapy to one week after radiotherapy, kang fu pen (recombinant human superoxide dismutase) retention enema, 50ml/ time, once every other day. when rectal mucosa ii degree reactions (nci-ctcae 5.0) occur, it is changed to 1 day/time until 1 week after mucosal remission. control group: 3 days before radiotherapy to the end of radiotherapy, no drug retention enema was used.

Eligibility 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.