NCT07616310 Rectosigmoid Lesion Excision vs. Resection: A Non-Inferiority Randomized Comparison in Advanced Ovarian Cancer
| NCT ID | NCT07616310 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Ovarian Cancer (OvCa) |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-01-10 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2024-01-10 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07616310 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Ovarian Cancer (OvCa). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07616310 currently recruiting?
Yes, NCT07616310 is actively recruiting participants. Contact the research team at feijing@zju.edu.cn for enrollment information.
Where is the NCT07616310 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07616310 clinical trial?
NCT07616310 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 300 participants.
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