Efficacy of Primary Debulking Surgery Versus Neoadjuvant Chemotherapy in Stage IV Ovarian Cancer

NCT05371301 | Unknown Phase 3

• 1 other identifier: FUSCC-GYN-20200816
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Epithelial ovarian cancer is mostly diagnosed at late stage (III/IV), and the standard treatment for ovarian cancer includes primary debulking surgery and platinum-based adjuvant chemotherapy. However, scholars suggest that neoadjuvant chemotherapy can be used to reduce the tumor load and control the patient's condition. The aim of this study is to verify the efficacy of primary debulking surgery versus neoadjuvant chemotherapy.

Conditions

Ovarian Cancer

Keywords

Ovarian Cancer; Neoadjuvant Chemotherapy; Interval Debulking Surgery

Outcome Measures

Primary Outcomes (2)

• Progression-Free-Survival

  Patients from surgery or neoadjuvant chemotherapy to disease progression or time to last follow-up

  5 year

• overall survival

  Patients from surgery or neoadjuvant chemotherapy to death or time to last follow-up

  5 year

Other Outcomes (2)

• postoperative residual lesions

  during surgery

• platinum sensitivity

  5 year

Study Arms (2)

NACT-IDS

EXPERIMENTAL

For patients whoes WB-DWI/MRI Suidan Standard Evaluation≥4 Neoadjuvant chemotherapy: platinum-based combination regimen 3 courses

Drug: Paclitaxel, Carboplatin; Procedure: debulking surgery

PDS

ACTIVE COMPARATOR

For patients whoes WB-DWI/MRI Suidan Standard Evaluation\<4

Procedure: debulking surgery

Interventions

Paclitaxel, Carboplatin DRUG

Paclitaxel 175mg/m2 iv d1 followed by Carboplatin(AUC=5) iv d1

NACT-IDS

debulking surgery PROCEDURE

Remove all visible tumors and any other tissues or organs where tumor may have spread, which may include: Uterus Fallopian tubes Omentum (tissue that covers the stomach, large intestine and other abdominal organs) Lymph nodes Diaphragm Part of the large bowel Spleen Parts of the liver

NACT-IDS; PDS

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients over 18 years of age.
• ECOG 0-2
• Clinically confirmed epithelial ovarian or fallopian-tube cancer or primary peritoneal cancer
• FIGO2014 stage III/IV
• Sign the informed consent form
• Good compliance and agree to cooperate with survival follow-up

You may not qualify if:

• Patients with large abdominal masses or other reasons for not being able to tolerate surgical treatment
• Patients with severe medical comorbidities that cannot be corrected in the short term and are not suitable for tumor cytoreductive surgery
• Patients with contraindications to chemotherapy
• Patients with a history of psychotropic substance abuse and unable to quit or patients with mental disorders
• Patients with serious safety hazards or concomitant diseases that, in the judgment of the institution, would affect the patient's ability to complete the study

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan university shanghai cancer center, Deparment of gynecologic oncology

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

CP protocol; Cytoreduction Surgical Procedures

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Xiaohua Wu, PhD&MD

  Fudan university shanghai cancer center, Deparment of gynecologic oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaohua Wu, PhD&MD

CONTACT

86-21-64175590; wu.xh@fudan.edu.cn

Zheng Feng, PhD

CONTACT

86-18121299572; lizfeng@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 12, 2022
• Study Start: July 16, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: May 12, 2022

Record last verified: 2022-05

Locations

CN (1)