Clinical trial NCT01342653: Clinical Trial at Neoadjuvant Peritoneal and Systemic Chemotherapy Plus HIPEC in Gastric Carcinomatosis
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 type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Peritoneal Carcinomatosis
Gastric Cancer
Keywords: Peritoneal
Carcinomatosis
Gastric
Cancer
NIPS
HIPEC
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2011-04-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: disease free survival
timeFrame: 36 months
Secondary outcomes:
measure: progression free survival
timeFrame: 36 months
measure: overall survival in patients with CC0
timeFrame: 36 month
measure: overall survival in patients who did not reach optimum cytoreduction
timeFrame: 36 months
measure: morbidity and mortality
timeFrame: first 30 days after surgery procedure
measure: Quality of life after phase I and Phase II
timeFrame: 36 months
Other outcomes:
Locations:
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
state: Madrid
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Centro Oncologico MD Anderson International España
Study officials:
References: