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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 520
- 试验地点
- 1
- 主要终点
- Degree of rectal mucosal injury caused by acute radiation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
test group
Intervention:Anti-radiation spray (liquid dressing)
干预措施: KANG FU PEN (Drug)
结局指标
主要结局
Degree of rectal mucosal injury caused by acute radiation
时间窗: Within 1 week after radiotherapy
the incidence of Vienna rectoscopy score ≥2 within 1 week after radiotherapy. Vienna rectoscopy score was used.
次要结局
- Quality of life score(3 to 24 months after radiotherapy)
- overall survival (OS)(3 years after radiotherapy)
- Degree of rectal injury caused by chronic radiation(3 to 24 months after radiotherapy)
- disease-progression-free survival (PFS)(3 years after radiotherapy)