Clinical Trial at Neoadjuvant Peritoneal and Systemic Chemotherapy Plus HIPEC in Gastric Carcinomatosis (HIPEC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01342653
Recruitment Status : Suspended (unable to reach planned recruitment)
First Posted : April 27, 2011
Last Update Posted : November 21, 2016
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Hospital General Universitario Gregorio Marañon

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.

Condition or disease Intervention/treatment Phase
Peritoneal Carcinomatosis Gastric Cancer Other: Intraperitoneal and systemic chemotherapy plus maximum cytoreduction plus HIPEC Phase 2

Detailed Description:

Patients with peritoneal carcinomatosis with gastric cancer who meet all inclusion criteria(and none of exclusion) will follow the next treatment scheme(40 week period of treatment):

Phase I (after one week of peritoneal catheter implant; total treatment 5-8 weeks): intraperitoneal infusion of Docetaxel(30 mg/m2) and Cisplatin (30mg/m2) in 1000 cc of saline. Intravenous administration 5-FU (200 mg/m2/Day, 7 days a week for 2 weeks) simultaneously with 2 cycles of Intraperitoneal administration.

These patients receive between four and six cycles of NIPS. Until phase II 4-6 weeks.

Phase II:cytoreduction (CR) plus HIPEC (total treatment 4 weeks). Maximal efforts to optimum cytoreduction.

HIPEC: intraperitoneal administration: Mytomicin C (15mg/m2)plus Adriamycin (15mg/m2) at 42-43ºC for 60 minutes.

Intravenous simultaneously administration 5-FU (400mg/m2) plus Leucovorin (20mg/m2) for 10 minutes at the beginning of peritoneal perfusion.

Phase III: adjuvant chemotherapy 8-12 weeks after surgery. Those cases reaching optimum cytoreduction (CC0) will be treated with systemic chemotherapy: First day: Docetaxel (75 mg/m2) Cisplatin (75mg/m2). Days 1-5: 5-FU (750mg/m2/d).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Multicentric Exploratory Single Cohort Clinical Trial to Assess Efficacy and Safety on a New Treatment Scheme by Systemic and Peritoneal Chemotherapy Plus Cytoreduction and HIPEC Plus Adjuvant Treatment in Patients With Peritoneal Carcinomatosis From Gastric Cancer
Study Start Date : January 2011
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: NIPS plus HIPEC plus adjuvant chemotherapy Other: Intraperitoneal and systemic chemotherapy plus maximum cytoreduction plus HIPEC
see Design

Primary Outcome Measures :
  1. disease free survival [ Time Frame: 36 months ]
    patients who reached optimum cytoreduction (CC0)after Phase II and eligible to complete adjuvant treatment(Phase III).

Secondary Outcome Measures :
  1. progression free survival [ Time Frame: 36 months ]
  2. overall survival in patients with CC0 [ Time Frame: 36 month ]
  3. overall survival in patients who did not reach optimum cytoreduction [ Time Frame: 36 months ]
  4. morbidity and mortality [ Time Frame: first 30 days after surgery procedure ]
  5. Quality of life after phase I and Phase II [ Time Frame: 36 months ]

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

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 identifier (NCT number): NCT01342653

Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, Spain, 28942
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Centro Oncologico MD Anderson International España
Madrid, Spain, 28033
Sponsors and Collaborators
Hospital General Universitario Gregorio Marañon
Instituto de Salud Carlos III

Responsible Party: Hospital General Universitario Gregorio Marañon Identifier: NCT01342653     History of Changes
Other Study ID Numbers: 2009-011162-29
First Posted: April 27, 2011    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: November 2016

Keywords provided by Hospital General Universitario Gregorio Marañon:

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type