NCT01342653

Brief Summary

Implementation of a curative strategy of treatment in peritoneal carcinomatosis of gastric cancer. The goal is to get 1C level of evidence (patient died with "standard" treatment, with this treatment some of them survive) in terms of disease free survival and overall survival. Methodology: prospective, phase II, multicentric in Spain. Recruitment of 50 patients(to have 31 on treatment) in three years. This strategy is based on neoadjuvant systemic plus simultaneous intraperitoneal and intravenous chemotherapy(NIPS),to treat peritoneal disease by bi-directional approach; next step is cytoreductive surgery and HIPEC. Once patients are discharged, they will follow a systemic adjuvant chemotherapy protocol.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
suspended

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

January 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2011

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

November 21, 2016

Status Verified

November 1, 2016

Enrollment Period

6 years

First QC Date

April 26, 2011

Last Update Submit

November 18, 2016

Conditions

Peritoneal CarcinomatosisGastric Cancer

Keywords

PeritonealCarcinomatosisGastricCancerNIPSHIPEC

Outcome Measures

Primary Outcomes (1)

  • disease free survival

    patients who reached optimum cytoreduction (CC0)after Phase II and eligible to complete adjuvant treatment(Phase III).

    36 months

Secondary Outcomes (5)

  • progression free survival

    36 months

  • overall survival in patients with CC0

    36 month

  • overall survival in patients who did not reach optimum cytoreduction

    36 months

  • morbidity and mortality

    first 30 days after surgery procedure

  • Quality of life after phase I and Phase II

    36 months

Study Arms (1)

NIPS plus HIPEC plus adjuvant chemotherapy

EXPERIMENTAL
Other: Intraperitoneal and systemic chemotherapy plus maximum cytoreduction plus HIPEC

Interventions

Intraperitoneal and systemic chemotherapy plus maximum cytoreduction plus HIPECOTHER

see Design

NIPS plus HIPEC plus adjuvant chemotherapy

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women aged 18-65 years old
  • Histological Evidence of peritoneal carcinomatosis from gastric cancer
  • No distance metastasis
  • ECOG 0-1-2
  • No contraindication for complex surgery
  • no other malign disease except skin cancer (different from melanoma or cervix cancer CIN III)
  • willing to consent and sign ICF.

You may not qualify if:

  • No Histological Evidence of peritoneal carcinomatosis from gastric cancer
  • Previous Gastrectomy due to gastric cancer.
  • Patients with gastric cancer and previous systemic chemotherapy
  • Peritoneal recurrence due to gastric cancer.
  • Distance metastasis
  • SP \>2 at recruitment or SP\>1 at surgery
  • previous radiotherapy treatment
  • pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, 28942, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, Madrid, 28007, Spain

Location

Centro Oncologico MD Anderson International España

Madrid, Madrid, 28033, Spain

Location

MeSH Terms

Conditions

Peritoneal NeoplasmsStomach NeoplasmsCarcinomaNeoplasms

Interventions

Infusions, ParenteralHyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Abdominal NeoplasmsNeoplasms by SiteDigestive System NeoplasmsDigestive System DiseasesPeritoneal DiseasesGastrointestinal NeoplasmsGastrointestinal DiseasesStomach DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeuticsChemotherapy, AdjuvantCombined Modality TherapyHyperthermia, Induced

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2011

First Posted

April 27, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

November 21, 2016

Record last verified: 2016-11

Locations

ES(3)