RecruitingNot ApplicableNCT06883409

Laparoscopic Interval Cytoreductive Surgery in Advance Ovarian Cancer

Efficiency of Laparoscopic Interval Cytoreductive Surgery After Neoadjuvant Chemotherapy in Patients With Stage III and IV Epithelial Ovarian Cancer

Sponsor

Instituto Nacional de Cancerologia de Mexico

Enrollment

33 participants

Start Date

May 19, 2022

Study Type

INTERVENTIONAL

Conditions

Ovarian Neoplasms

Summary

This is a study that aims to demonstrate the non-inferiority of minimally invasive surgery versus open surgery, as an approach for patients with advanced ovarian cancer who received neoadjuvant chemotherapy, giving them the benefits of laparoscopic surgery. This way they can continue with their complementary treatment.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether laparoscopic (minimally invasive) cytoreductive surgery — surgery to remove as much cancer as possible — can be performed safely in women with advanced ovarian cancer who have responded well to chemotherapy given before surgery. **You may be eligible if...** - You have been diagnosed with advanced (stage III or IV) epithelial ovarian cancer - You have had 3–4 cycles of chemotherapy before surgery and your cancer has partially or fully responded, as shown on PET-CT scan - Your cancer marker CA-125 is below 200 - You are in generally good health and able to tolerate surgery **You may NOT be eligible if...** - You still have fluid buildup (ascites or pleural effusion) despite chemotherapy - Your cancer has spread in ways that make complete surgical removal extremely unlikely (e.g., multiple liver spots, large lymph nodes above the kidneys, spread above the diaphragm, or extensive bowel involvement) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREInterval Cytoreduction Surgery

The procedure started with the cytoreduction of highest complexity (determined at the time of initial inspection), after which, if necessary, the patient underwent a complete hysterectomy, bilateral salpingo-oophorectomy, omentectomy, or partial peritonectomy and excision of any peritoneal implants present. The magnitude of the surgical procedures will be classified as: 1. Standard surgery: minimal hysterectomy, adnexectomy y omentectomy 2. Radical Surgery: included resection of the ovaries, of the rectouterine excavation (pouch of Douglas) and or the peritoneum between the bladder and uterus, hysterectomy, rectosigmoid colectomy, and complete omentectomy 3. Supra-radical Surgery: included other procedures such as splenectomy, diaphragm resection, or other intestinal resection.

Locations(1)

Instituto Nacional de Cancerologia

México, Tlalpan, Mexico

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NCT06883409

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