Cytoreduction With or Without Intraoperative Intraperiton... | NCT02328716

Studies
Cytoreduction With or Without Intraoperative Intraperitoneal Hyperthermic Chemotherapy (HIPEC) in Patients With Peritoneal Carcinomatosis From Ovarian Cancer, Fallopian Tube or Primary Peritoneal Carcinoma

NCT02328716

Sponsor

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Status

Unknown status

Last Update Posted

Dec 13, 2017Actual

Enrollment

32Estimated

Phase

Phase 3

Conditions

Peritoneal Carcinomatosis From Ovarian Cancer
Fallopian Tube Carcinoma
Primary Peritoneal Carcinoma

Interventions

Cytoreduction
Hipec with Cisplatin

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2011-001715-31	EudraCT Number

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012Actual

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Dec 5, 2014

First Submission Date that Met QC Criteria

Dec 29, 2014

First Posted Date

Dec 31, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2017

Last Update Posted Date

Dec 13, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Comparator	Active Comparator	Comparator	Procedure: Cytoreduction
Experimental	Experimental	Experimental	Procedure: Cytoreduction Drug: Hipec with Cisplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cytoreduction	Procedure	Cytoreduction	Comparator Experimental

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
disease-free survival period	Every three months until recurrence of disease.	Every 3 months up to 30 months

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of overall survival.	Every three months until recurrence of disease.	Every 3 months up to 30 months
Study of morbidity.	Every three months until recurrence of disease.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pedro Cascales Campos, MD,PhD	Contact

Overall Officials

Name	Affiliation	Role
Pedro Cascales Campos, M.D Phd	Hospital Universitario Virgen de la Arrixaca	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Clínico Universitario Virgen de la Arrixaca	Recruiting	El Palmar	Murcia	30120	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31069579	Derived	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.

ID	Term
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005184	Fallopian Tube Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases

ID	Term
D065426	Cytoreduction Surgical Procedures
D000084262	Hyperthermic Intraperitoneal Chemotherapy
D002945	Cisplatin

ID	Term
D013514	Surgical Procedures, Operative
D017024	Chemotherapy, Adjuvant
D003131	Combined Modality Therapy
D013812	Therapeutics
D004358	Drug Therapy
D006979	Hyperthermia, Induced
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds