Rectosigmoid Lesion Excision vs. Resection: A Non-Inferiority Randomized Comparison in Advanced O… (NCT07616310) | Clinical Trial Compass
RecruitingNot Applicable
Rectosigmoid Lesion Excision vs. Resection: A Non-Inferiority Randomized Comparison in Advanced Ovarian Cancer
China300 participantsStarted 2024-01-10
Plain-language summary
Colorectum is the most common site of metastasis in ovarian cancer. Regarding intestinal surgery, there is controversy over whether to choose bowel resection or tumor removal, and currently, there are no prospective randomized controlled studies comparing the oncological safety of these two surgical approaches. This study is a prospective randomized trial aimed at comparing the efficacy of rectosigmoid resection versus rectosigmoid-preserving lesion excision in advanced ovarian cancer surgery.
Who can participate
Age range
18 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Voluntarily participate in this study and sign the informed consent form;
* Age 18-70 years old;
* Primary debulking surgery for epithelial ovarian cancer (including neoadjuvant chemotherapy), with or without abdominal and distant metastasis (≥ IIB stage);
* Colonoscopy negative (no mucosal layer invasion);
* Preoperative imaging (enhanced pelvic MRI) assesses the tumor's involvement of the intestinal surface and/or major parts of the mesentery;
* Eastern Cooperative Oncology Group (ECOG) score \< 3;
* American Society of Anesthesiologists (ASA) score \< 3.
Exclusion Criteria:
* Has a history of other malignant tumors or is undergoing other anti-tumor treatments;
* Has severe underlying medical conditions that make surgery intolerable;
* Epithelial ovarian cancer diagnosed incidentally during emergency surgery;
* Participates in other clinical studies simultaneously;
* Secondary cytoreductive surgery for epithelial ovarian cancer;
* Patients who have received radiotherapy to the abdomen or pelvis before.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-free survival(PFS)
Timeframe: Two years after the surgery
Trial details
NCT IDNCT07616310
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University