NCT02328716

Brief Summary

The purpose of this clinical trial is to Investigate whether the administration of HIPEC with Cisplatin (75 milligrams per square meter of body surface) after surgical cytoreduction in women with ovarian, tubal or primary peritoneal carcinoma increased disease-free survival period compared with patients without HIPEC treatment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2012

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2014

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

December 13, 2017

Status Verified

December 1, 2017

Enrollment Period

6.8 years

First QC Date

December 5, 2014

Last Update Submit

December 12, 2017

Conditions

Peritoneal Carcinomatosis From Ovarian CancerFallopian Tube CarcinomaPrimary Peritoneal Carcinoma

Outcome Measures

Primary Outcomes (1)

  • disease-free survival period

    Every three months until recurrence of disease.

    Every 3 months up to 30 months

Secondary Outcomes (4)

  • Evaluation of overall survival.

    Every 3 months up to 30 months

  • Study of morbidity.

    Every 3 months up to 30 months

  • Evaluation of quality of life related to the procedure.

    Every 3 months up to 30 months

  • Study of Ex vivo correlation.

    4 days post surgery

Study Arms (2)

Comparator

ACTIVE COMPARATOR

Comparator

Procedure: Cytoreduction

Experimental

EXPERIMENTAL

Experimental

Procedure: CytoreductionDrug: Hipec with Cisplatin

Interventions

CytoreductionPROCEDURE

Cytoreduction

ComparatorExperimental
Hipec with CisplatinDRUG

Intraoperative Intraperitoneal Hyperthermic Chemotherapy (Hipec)+Cisplatin

Experimental

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Peritoneal carcinomatosis arising from ovarian epithelial carcinoma (stage III or higher), carcinoma of the fallopian tube and primary peritoneal carcinoma.
  • Residual tumor \< 2.5 mm after completion of cytoreductive surgery.
  • Aged \< 75 years.
  • Baseline ECOG 0-1 (Eastern Cooperative Oncologic Group).
  • Adequate bone marrow function with hemoglobin ? 8 g/dl (after correction for iron deficiency anemia), white blood cell count ? 3,000/mm3, platelets ? 100,000/mm3.
  • Adequate renal function with creatinine ? 1.5 mg/ dl.
  • Adequate liver function with bilirubin levels ? 1.5 mg / dl and AST and ALT ? 80 IU / L.
  • Optimal cardiopulmonary function.
  • In recurrences, disease-free interval \> 6 months.
  • Voluntary and signed written informed consent.

You may not qualify if:

  • Extraperitoneal tumor disease.
  • Suboptimal debulking (residual tumor \> 2.5 mm).
  • Previous history of other malignancies (excluding skin)
  • Intestinal obstruction at the time of evaluation.
  • Renal failure.
  • Heart failure.
  • Uncontrolled infection.
  • Pregnant or lactating patients.
  • In recurrences, disease-free interval \< 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital ClĂ­nico Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

RECRUITING

Related Publications (1)

  • Cascales Campos PA, Gonzalez-Gil A, Gomez-Ruiz AJ, Gil-Gomez E, Alconchel-Gago F, Navarro-Barrios A, Martinez-Garcia J, Alonso-Romero JL, Nieto A, Barcelo-Valcarcel F, Gil-Martinez J. Risk factors and management of incisional hernia after cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with peritoneal surface malignancies. Hernia. 2020 Apr;24(2):257-263. doi: 10.1007/s10029-019-01962-4. Epub 2019 May 8.

    PMID: 31069579DERIVED

MeSH Terms

Conditions

Fallopian Tube Neoplasms

Interventions

Cytoreduction Surgical ProceduresHyperthermic Intraperitoneal ChemotherapyCisplatin

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFallopian Tube DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeChemotherapy, AdjuvantCombined Modality TherapyTherapeuticsDrug TherapyHyperthermia, InducedChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Pedro Cascales Campos, M.D Phd

    Hospital Universitario Virgen de la Arrixaca

    STUDY DIRECTOR

Central Study Contacts

Pedro Cascales Campos, MD,PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2014

First Posted

December 31, 2014

Study Start

February 1, 2012

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

December 13, 2017

Record last verified: 2017-12

Locations

ES(1)