HIPEC in Ovarian Carcinoma Clinical Stage IIIC and IV During Interval Laparotomy

NCT03275194 | Recruiting Phase 2 DMC

• 1 other identifier: INCAN/CI/483/15
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Ovarian cancer is the leading cause of gynecological cancer mortality, with no current screening method effective for early diagnosis, with 75% of advanced stage patients being detected. Not all patients are candidates for standard treatment, which is primary cytoreduction followed by adjuvant chemotherapy, due to the advanced process. A subgroup of patients will receive neoadjuvant chemotherapy followed by interval surgery, which allows higher rates of optimal cytoreduction with low morbidity and mortality. Hyperthermic intraperitoneal chemotherapy (HIPEC) is a therapeutic option that is used in pathologies of peritoneal dissemination, whose morbidity and mortality has been reported in several series and is promising as a management option for ovarian cancer, so it is necessary to evaluate morbidity and mortality that conditions this modality of treatment as well as if it impacts on the quality of life of the patients to whom they are performed, which will allow offering our patients an option of additional treatment to the standard.

Conditions

HPEC; Ovarian Cancer; Women's Health: Neoplasm of Ovary; Chemotherapy Effect

Outcome Measures

Primary Outcomes (3)

• Mortality

  To assess the mortality associated with the use of intraperitoneal hyperthermic chemotherapy during interval laparotomy.

  Up to 1 year

• Impact of quality of life

  To evaluate the impact on patients' quality of life, which is undergoing intraperitoneal hyperthermic chemotherapy during interval laparotomy. The scales that will be used will be EORTC QLQ-C30 (Ver. 3) and EORTC QLQ-OV28.

  Up to 1 year

• Morbility

  To assess the morbidity associated with the use of intraperitoneal hyperthermic chemotherapy during interval laparotomy.

  Up to 1 year

Secondary Outcomes (2)

• Disease free survival

  Up to 2 years

• Overall survival

  up to five years

Study Arms (2)

Control group

NO INTERVENTION

After achieving a complete cytoreductive surgery (no visible residual disease), the patient will be randomised and if is assigned to this arm does not receive additional treatment and the procedure will be finished.

HIPEC group

EXPERIMENTAL

After achieving a complete cytoreductive surgery (no visible residual disease), the patient will be randomised and if is assigned to this arm receive a HIPEC procedure with cisplatin and doxorubicin.

Procedure: HIPEC

Interventions

HIPEC PROCEDURE

Following complete cytoreductive surgery without any evidence of residual disease, the patient will be randomized either HIPEC (intervention) or no-HIPEC (control) in the operative Room. If the arm HIPEC is obtained, then a HIPEC procedure with cisplatin and doxorubicin will be performed. If no-HIPEC (control arm) is assigned then the surgical procedure will be finished.

HIPEC group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Genotypic sex
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients younger than 70 years
• Patient with a diagnosis of high grade serous carcinoma of the ovary and low-grade endometrioid corroborated by histopathological study.
• Clinical stage IIIC and IVA (cytology-positive pleural effusion) who have received induction chemotherapy 3 or 4 cycles of CARBOPLATIN and PACLITAXEL.
• Partial response to treatment with chemotherapy and evaluated by computed tomography (RECIST-see below) and response of at least 50% by serum determination of CA-125 antigen.
• Signature of informed consent.
• Optimal cytoreduction with residual tumor less than 2.5 mm during interval surgery
• ECOG less than or equal to 1
• Adequate renal, cardiac, hepatic, bone marrow and lung function evaluated preoperatively with the following parameters:
• a) Hb equal to or greater than 10 g / L (pre-treatment transfusion is permitted to achieve this hemoglobin level) b) Leukocytes Greater than 3000 / mm3 (c) Platelets equal to or greater than 100 000 / mm3 (d) total bilirubin less than 1.5 times greater than the normal value e) Hepatic transaminases less than 1.5 times higher than normal value f) Creatinine \<1.2 g / dl. In case of being elevated the measured purification should be greater than 60mL / min according to Cockroft's formula.
• g) Albumin greater than 3gr / dl. h) Left Ventricle Ejection fraction per cardiac echography greater than 55% 9). Sugarbaker carcinomatosis index less than 20

You may not qualify if:

• Patients with heart failure, ischemic heart disease
• Previous history of treatment with chemotherapy for some other neoplasia
• History of neuropsychiatric disease
• Patients with intra operative bleeding that condition hemodynamic instability.
• Patient requiring more than 2 intraoperative anastomosis

Sponsors & Collaborators

• Instituto Nacional de Cancerologia de Mexico: lead

Study Sites (1)

National Cancer Institute of Mexico

Mexico City, 14080, Mexico

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

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)

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

Study Officials

• Rosa A Salcedo-Hernandez, MSc

  Instituto Nacional de Cancerologia, Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The data will be evaluated for a external person with the groups labeled as "A" and "B" for all outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical oncologist, Gynecology oncology division

Study Record Dates

• First Submitted: September 2, 2017
• First Posted: September 7, 2017
• Study Start: September 2, 2017
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 28, 2023

Record last verified: 2023-04

Locations

ME (1)