Clinical trial · Interventional
Clinical Trial at Neoadjuvant Peritoneal and Systemic Chemotherapy Plus HIPEC in Gastric Carcinomatosis
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): unable to reach planned recruitment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Peritoneal Carcinomatosis | Peritoneal Carcinomatosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraperitoneal and systemic chemotherapy plus maximum cytoreduction plus HIPEC | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NIPS plus HIPEC plus adjuvant chemotherapy
- interventionNames
- Other: Intraperitoneal and systemic chemotherapy plus maximum cytoreduction plus HIPEC
Primary outcomes (1)
- measure
- disease free survival
- timeFrame
- 36 months
- description
- patients who reached optimum cytoreduction (CC0)after Phase II and eligible to complete adjuvant treatment(Phase III).
Secondary outcomes (5)
- measure
- progression free survival
- timeFrame
- 36 months
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 64 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available