Rectosigmoid Lesion Excision vs. Resection in Advanced Ovarian Cancer
Official title: A Prospective Randomized Controlled Non-Inferiority Study Comparing the Efficacy of Lesion Excision Versus Rectosigmoid Resection in Pelvic Cytoreductive Surgery for Advanced Ovarian Cancer
Run by Second Affiliated Hospital, Zhejiang University, School of Medicine · NCT07616310 · Data updated 2026-11-12
This study tests whether removing a rectosigmoid lesion without full bowel resection can be as safe as removing the bowel segment in women with advanced ovarian cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | Women only |
| Enrollment | 300 (estimated) |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | January 10, 2024 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | June 1, 2026 |
| Trial ID | NCT07616310 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–70 with epithelial ovarian cancer undergoing primary debulking and imaging suggesting rectosigmoid involvement amenable to lesion excision, ECOG 0–2, and ASA 1–2.
✕Probably not a fit
Patients with extensive rectosigmoid invasion or unsuitable anatomy may not benefit and could require more extensive resection.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, non-inferiority trial compares two surgical approaches for advanced ovarian cancer with rectosigmoid involvement: lesion excision preserving the rectosigmoid colon versus traditional rectosigmoid resection. All participants undergo primary debulking surgery with tumor debulking as indicated, and trial arms differ by the bowel procedure performed. Outcomes focus on oncological safety and surgical morbidity, including rates of anastomotic leakage and bowel function, to determine if less extensive surgery can achieve comparable cancer control with potentially better quality of life. Eligibility targets adults aged 18–70 with epithelial ovarian cancer undergoing primary debulking, adequate performance status, and imaging suggesting limited rectosigmoid involvement. The study is conducted at the Second Affiliated Hospital, Zhejiang University, with collaboration from Tongji Hospital and Zhejiang Provincial People's Hospital.
Why it matters
Potential benefit: If lesion excision proves non-inferior, patients may benefit from less extensive bowel surgery, potentially reducing complications and preserving bowel function.
How similar studies have gone: Prior studies have explored organ-preserving approaches in colorectal involvement, but prospective randomized data comparing lesion excision to resection in ovarian cancer are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Jing Fei
- Email: feijing@zju.edu.cn
- Phone: +86 13732238958
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.