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

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ClinicalTrials.gov Identifier: NCT03275194
Recruitment Status : Recruiting
First Posted : September 7, 2017
Last Update Posted : September 7, 2017
Sponsor:
Information provided by (Responsible Party):
Rosa A. Salcedo, Instituto Nacional de Cancerologia de Mexico

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.

Condition or disease Intervention/treatment Phase
HPEC Ovarian Cancer Women's Health: Neoplasm of Ovary Chemotherapy Effect Procedure: HIPEC Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The data will be evaluated for a external person with the groups labeled as "A" and "B" for all outcomes.
Primary Purpose: Treatment
Official Title: Hyperthermic Intraperitoneal Chemotherapy in Ovarian Carcinoma Clinical Stage IIIC and IV During Interval Laparotomy. Phase II Study
Actual Study Start Date : September 2, 2017
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
No Intervention: Control group
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.
Experimental: HIPEC group
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
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.




Primary Outcome Measures :
  1. Mortality [ Time Frame: Up to 1 year ]
    To assess the mortality associated with the use of intraperitoneal hyperthermic chemotherapy during interval laparotomy.

  2. Quality of life [ Time Frame: Up to 1 year ]
    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.

  3. Morbility [ Time Frame: Up to 1 year ]
    To assess the morbidity associated with the use of intraperitoneal hyperthermic chemotherapy during interval laparotomy.


Secondary Outcome Measures :
  1. Disease free survival [ Time Frame: Up to 2 years ]
    Evaluate disease-free survival.

  2. Overall survival [ Time Frame: up to five years ]
    Evaluate overall 5 year survival.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Genotypic sex
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients younger than 70 years
  2. Patient with a diagnosis of high grade serous carcinoma of the ovary and low-grade endometrioid corroborated by histopathological study.
  3. Clinical stage IIIC and IVA (cytology-positive pleural effusion) who have received induction chemotherapy 3 or 4 cycles of CARBOPLATIN and PACLITAXEL.
  4. 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.
  5. Signature of informed consent.
  6. Optimal cytoreduction with residual tumor less than 2.5 mm during interval surgery
  7. ECOG less than or equal to 1
  8. 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03275194


Locations
Mexico
National Cancer Institute of Mexico Recruiting
Mexico City, Mexico, 14080
Contact: Rosa A Salcedo-Hernández, M.Sc    525534265921    rosasalher@gmail.com   
Contact: Leonardo S Lino-Silva    525534265921    saul.lino.sil@gmail.com   
Sponsors and Collaborators
Instituto Nacional de Cancerologia de Mexico
Investigators
Principal Investigator: Rosa A Salcedo-Hernandez, MSc Instituto Nacional de Cancerologia, Columbia

Responsible Party: Rosa A. Salcedo, Surgical oncologist, Gynecology oncology division, Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier: NCT03275194     History of Changes
Other Study ID Numbers: INCAN/CI/483/15
First Posted: September 7, 2017    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The database without any patient identity data could be accede for anyone asking for.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders