NCT02739698

Brief Summary

A randomized controlled single-blind clinical trial was performed, in 32 patients diagnosed with peritoneal carcinomatosis from epithelial ovarian cancer, who underwent radical surgery-peritonectomy, achieving an optimal R0-R1 cytoreduction (microscopic tumor residues (R0) or macroscopic tumor residues \< 1cm (R1)) followed by hyperthermia against normothermia intraperitoneal intraoperative chemotherapy with paclitaxel

Trial Health

100
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2012

Longer than P75 for phase_2

Status
completed

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

July 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
5 months until next milestone

Results Posted

Study results publicly available

August 1, 2017

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

2.3 years

First QC Date

April 4, 2016

Results QC Date

March 28, 2017

Last Update Submit

July 4, 2017

Conditions

Peritoneal Carcinomatosis

Keywords

ovarian cancer

Outcome Measures

Primary Outcomes (1)

  • The Grouped Miller and Payne (MP) System for Pathological Response: G1 (Minimal Changes and < 30% Cells Tumour Reduction That Includes MP G1-G2), G3 (Microscopic Foci, Cells Tumour Reduction up to >90% That Includes MP G3-G4) and G5 (no Residual Tumour)

    Histopathology scoring system to assess response, previous and post intraperitoneal intraoperative chemotherapy. Compare cancer cellularity of the biopsy (before treatment) with the other biopsy (after treatment).

    The biopsies were taken before and after the treatment (intraperitoneal intraoperative chemotherapy for 60 minutes) and then they were analysed by two blinded pathologists.

Study Arms (2)

normothermic (36-37ºC)

EXPERIMENTAL

Group 1, n=16(normothermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1.5% dextrose in room temperature (36-37ºC).

Drug: PaclitaxelProcedure: Radical surgery-peritonectomy

hyperthermic (41-42ºC)

EXPERIMENTAL

Group 2, n=16 (hyperthermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1.5% dextrose in continuous hyperthermic perfusion (41-42ºC).

Drug: PaclitaxelProcedure: Radical surgery-peritonectomy

Interventions

PaclitaxelDRUG
hyperthermic (41-42ºC)normothermic (36-37ºC)
Radical surgery-peritonectomyPROCEDURE
hyperthermic (41-42ºC)normothermic (36-37ºC)

Eligibility Criteria

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

You may qualify if:

  • age ranged between 18 and 75 years old;
  • histopathologic confirmation of peritoneal carcinomatosis from epithelial ovarian cancer (stage IIIc- FIGO (International Federation of Gynecology and Obstetrics));
  • Karnofsky index \> 70 or performance status ≤2;
  • informed consent form filled out correctly.

You may not qualify if:

  • extraabdominal metastasis or stage IV FIGO (liver, lung, bone, etc);
  • concomitance of another malignant neoplasm;
  • renal, hepatic or cardiovascular dysfunction;
  • intolerance during the treatment; - (6) refusal to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Fernandez-Peralbo MA, Priego-Capote F, Luque de Castro MD, Casado-Adam A, Arjona-Sanchez A, Munoz-Casares FC. LC-MS/MS quantitative analysis of paclitaxel and its major metabolites in serum, plasma and tissue from women with ovarian cancer after intraperitoneal chemotherapy. J Pharm Biomed Anal. 2014 Mar;91:131-7. doi: 10.1016/j.jpba.2013.12.028. Epub 2014 Jan 2.

    PMID: 24447964RESULT

MeSH Terms

Conditions

Peritoneal NeoplasmsOvarian Neoplasms

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Abdominal NeoplasmsNeoplasms by SiteNeoplasmsDigestive System NeoplasmsDigestive System DiseasesPeritoneal DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Results Point of Contact

Title
Angela Casado-Adam, MD
Organization
University Hospital Reina Sofia, Cordoba, Spain
angeti@hotmail.com
0034957010439

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, MD

Study Record Dates

First Submitted

April 4, 2016

First Posted

April 15, 2016

Study Start

July 1, 2012

Primary Completion

November 1, 2014

Study Completion

March 1, 2017

Last Updated

August 1, 2017

Results First Posted

August 1, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share