HIPEC in Ovarian Cancer, Case-Controls Study With 10-years Follow up

NCT04234243 | Completed DMC

• 1 other identifier: COE-UEI/05/PT/2016
• Study Type: observational
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objectives: Compare overall survival (OS) and progression-free survival (PFS) among ovarian cancer patients who underwent into cytoreduction and HIPEC procedure vs patients who only received systemic chemotherapy in a 10-years follow up of a case-control study Methods: Cases were defined as patients treated by cytoreduction and HIPEC, and were matched (1:2) with patients treated with chemotherapy only, defined as controls. PFS and OS in the two groups were measured and compared. PFS was calculated from initiation of treatment to progression, death or to the last known follow-up. OS was calculated from initiation of treatment to death or to the last known follow-up.

Conditions

Ovarian Cancer; HIPEC

Keywords

HIPEC

Outcome Measures

Primary Outcomes (2)

• free overall survival

  survillance from HIPEC procedure/IV chemotherapy for carcinomatosis, to death date or last consultation (months) Kaplan Meier curve

  10 years

• free recurrence survival

  survillance from HIPEC procedure/IV chemotherapy for carcinomatosis, to recurrence date (months) Kaplan Meier curve

  10 years

Secondary Outcomes (1)

• factors associated with survival

  10 years

Study Arms (2)

HIPEC

women, with ovarian cancer stage III-IV or recurrent with carcinomatosis treated with cytoreduction and HIPEC

Procedure: cytoreduction and HIPEC

No HIPEC

women, with ovarian cancer stage III-IV or recurrent with carcinomatosis, treated with systemic chemotherapy only

Interventions

cytoreduction and HIPEC PROCEDURE

cytoreduction CCR 0-1, and HIPEC close technique

HIPEC

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIPEC population: 46 patients No HIPEC population : 92 patients

You may qualify if:

• Diagnosis of Epithelial ovarian cancer confirmed
• FIGO stage III-IV or carcinomatosis recurrence
• No comorbidities or controlled comorbidities
• ECOG 0-2

You may not qualify if:

• without carcinomatosis

Sponsors & Collaborators

• Instituto de Seguridad Social del Estado de Mexico y Municipios: lead

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Cytoreduction Surgical Procedures; Hyperthermic Intraperitoneal Chemotherapy

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; Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Peritoneal Malignacy neoplasm coordinator

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 21, 2020
• Study Start: August 1, 2007
• Primary Completion: December 31, 2017
• Study Completion: August 31, 2019
• Last Updated: January 29, 2020

Record last verified: 2020-01