Trials / Unknown
UnknownNCT04345770
Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Gastric Cancer
A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Locally Advanced Gastric Cancer
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Wuhan University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal metastasis in locally advanced gastric cancer is not definite. The hypothesis of the trial is that radical gastrectomy combined with HIPEC is superior to only radical gastrectomy in terms of overall survival.
Detailed description
To determine the efficacy of HIPEC in the treatment of locally advanced gastric cancer, patients are randomized into HIPEC group and control group. In HIPEC group, the patients undergo neoadjuvant chemotherapy followed by radical gastrectomy with D2 lymphadenectomy and HIPEC with paclitaxel and 5-Fu. Patients in the control group just undergo neoadjuvant chemotherapy followed by radical gastrectomy with D2 lymphadenectomy. Patients in both groups receive postoperative chemotherapy (6 circles together with neoadjuvant chemotherapy) and are followed up for 5 years or until death. The trial is designed as a prospective, randomized, open and parallel group study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | D2 radical gastrectomy | radical gastrectomy with D2 lymphadenectomy |
| DRUG | SOX neoadjuvant or postoperative chemotherapy | Oxaliplatin 130mg/m2 d1, Tegafur,Gimeracil and Oteracil Porassium Capsules 60mg, d1-14. |
| PROCEDURE | Hyperthermic intraperitoneal chemotherapy (HIPEC) | Normal saline 3000ml-4000ml, Paclitaxel 75mg/m2, 5-Fu 15mg/m2, 43°C, 60min. |
Timeline
- Start date
- 2020-04-01
- Primary completion
- 2025-03-31
- Completion
- 2025-05-31
- First posted
- 2020-04-14
- Last updated
- 2020-04-14
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04345770. Inclusion in this directory is not an endorsement.