A Multicenter, Non-Inferiority, Phase III Randomized Controlled Trial Comparing Moderately Hypofractionated Online Adaptive Radiotherapy（MH-ART） vs. Conventional Fractionated Intensity-Modulated Radiotherapy（CF-IMRT） in Postoperative Cervical Cancer and Endometrial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 228
- 试验地点
- 2
研究概览
简要总结
This is an investigator-initiated, prospective, national multi-center, phase III, randomized, open-label, non-inferiority clinical study. The hypothesis is that using online adaptive radiotherapy technology for moderately fractionated radiotherapy in post-operative patients with cervical/endometrial cancer may reduce radiotherapy-related toxicity and improve quality of life while ensuring target coverage. The objective is to evaluate treatment-related toxicity and efficacy of moderately fractionated online adaptive radiotherapy compared to conventionally fractionated intensity-modulated radiotherapy in post-operative cervical and endometrial cancer patients, aiming to provide a more precise, convenient, and cost-effective treatment option for patients.
详细描述
Randomization:
Intervention Group: Moderately fractionated radiotherapy using online adaptive radiotherapy technology.
Control Group: Conventionally fractionated radiotherapy using image-guided intensity-modulated radiotherapy technology.
Stratification Factors for Randomization:Participating study center; Disease type (Cervical cancer / Endometrial cancer); Receipt of concurrent chemotherapy
Study Objectives:
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants must be fully voluntary and have decision-making capacity, providing written informed consent within 30 days prior to enrollment.
- •Age ≥18 years and ≤75 years.
- •ECOG performance status of 0-1, and expected to tolerate lying supine for half an hour.
- •Have undergone radical surgery for cervical cancer (procedure: radical hysterectomy + pelvic lymphadenectomy ± para-aortic lymphadenectomy) or surgery for endometrial cancer (procedure: total hysterectomy + bilateral salpingo-oophorectomy ± pelvic and/or para-aortic lymph node dissection/sampling or sentinel lymph node biopsy).
- •For participants with cervical cancer, the following criteria must be met:
- •(1)Pathologically diagnosed with cervical squamous cell carcinoma or adenocarcinoma.
- •(2)Must have at least one of the following high-risk factors; or have other risk factors requiring postoperative radiotherapy: High-risk factors: Pelvic lymph node metastasis, or positive surgical margin, or parametrial invasion.
- •Other risk factors: Middle or deep one-third stromal invasion, regardless of tumor size and LVSI status; Tumor size ≥4cm, regardless of depth of stromal invasion and LVSI status; Adenocarcinoma: Tumor size ≥2cm, or positive LVSI, regardless of depth of stromal invasion.
- •6.For participants with endometrial cancer, the following criteria must be met: Endometrioid adenocarcinoma: Grade 3 with superficial myometrial invasion, accompanied by substantial LVSI or age ≥70 years; Grade 2 with deep myometrial invasion, accompanied by substantial LVSI or age ≥60 years; Grade 3 with deep myometrial invasion; FIGO 2009 Stage II-IIIC
- •Non-endometrioid adenocarcinoma: FIGO 2009 Stage I-IIIC1 (serous carcinoma, clear cell carcinoma, mixed type).
- •7.Participants with high-risk factors may receive a vaginal brachytherapy boost following the completion of external beam radiotherapy.
- •8.Participants with high-risk cervical cancer must receive concurrent sensitizing chemotherapy for ≥4 cycles.
- •9.Participants must be eligible to receive sequential or sandwich adjuvant chemotherapy as planned.
排除标准
- •Presence of confirmed distant metastasis or para-aortic lymph node metastasis;
- •Requirement for extended-field radiotherapy encompassing the para-aortic region;
- •Initiation of radiotherapy exceeds the specified time limit after surgery: exceeding 6 months post-surgery if adjuvant chemotherapy was administered, or exceeding 3 months post-surgery if no adjuvant chemotherapy was administered;
- •History of previous abdominal or pelvic radiotherapy;
- •History of or concurrent secondary primary malignancy (except for non-melanoma skin cancer, papillary/follicular thyroid carcinoma, or carcinoma in situ of the breast);
- •History of underlying intestinal diseases such as ulcerative colitis or Crohn's disease;
- •Cervical cancer with pathological types such as adenosquamous carcinoma, small cell carcinoma, clear cell carcinoma, or other special types; Endometrial cancer with pathological types such as undifferentiated carcinoma, carcinosarcoma, or other special types;
- •Pregnant or lactating women;
- •Presence of active infection or fever;
- •Other severe comorbidities that may significantly compromise protocol compliance, such as uncontrolled cardiac disease requiring treatment, renal disease, chronic hepatitis, poorly controlled diabetes, psychiatric disorders, etc.
研究组 & 干预措施
MH-ART
Moderately fractionated radiotherapy using online adaptive radiotherapy technology.
干预措施: Moderately fractionated radiotherapy using online adaptive radiotherapy technology (Radiation)
CF-IMRT
Conventionally fractionated radiotherapy using image-guided intensity-modulated radiotherapy technology.
干预措施: Conventionally fractionated radiotherapy using image-guided intensity-modulated radiotherapy technology. (Radiation)
研究者
Xiaorong Hou
Professor
Peking Union Medical College Hospital