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

Gastric Cancer Clinical Trial

— HIPEC  

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01342653
• Other study ID #: 2009-011162-29
• Status: Suspended
• Phase: Phase 2
• First received: April 26, 2011
• Last updated: November 18, 2016
• Start date: January 2011
• Est. completion date: January 2017

Study information

• Verified date: November 2016
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 50
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Gastric Cancer
• Peritoneal Carcinomatosis
• Stomach Neoplasms

Intervention

Other:
• Intraperitoneal and systemic chemotherapy plus maximum cytoreduction plus HIPEC
see Design

Locations

Country	Name	City	State
Spain	Hospital Universitario de Fuenlabrada	Fuenlabrada	Madrid
Spain	Centro Oncologico MD Anderson International España	Madrid
Spain	Hospital General Universitario Gregorio Marañon	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Hospital General Universitario Gregorio Marañon	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease free survival	patients who reached optimum cytoreduction (CC0)after Phase II and eligible to complete adjuvant treatment(Phase III).	36 months	No
Secondary	progression free survival		36 months	No
Secondary	overall survival in patients with CC0		36 month	No
Secondary	overall survival in patients who did not reach optimum cytoreduction		36 months	No
Secondary	morbidity and mortality		first 30 days after surgery procedure	Yes
Secondary	Quality of life after phase I and Phase II		36 months	No