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

Hospital General Universitario Gregorio Marañon

Status and phase: Suspended; Phase 2

Conditions: Gastric Cancer; Peritoneal Carcinomatosis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01342653

2009-011162-29

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

NIPS plus HIPEC plus adjuvant chemotherapy

Experimental group

Treatment:

Other: Intraperitoneal and systemic chemotherapy plus maximum cytoreduction plus HIPEC