MedDataX Logo

Sequential HIPEC of Oxaliplatin and Paclitaxel for Gastric Cancer Patients With Peritoneum Metastasis

NCT ID: NCT01471132

Last Updated: 2012-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The recurrence and metastasis of peritoneum is always the lethal consequence for gastric cancer patients, and there is no effective therapy until now. It has been reported by Dr.Fujimoto that intraperitoneal chemotherapy plus hyperthermic therapy, which called hyperthermic intraperitoneal chemotherapy (HIPEC), can eliminate and suppress the free cancer cells and tiny metastasis in abdomen. Refer to the experience of systematic chemotherapy, HIPEC with combination regimen would have a brighter prospect. In this study, the investigators would use Oxaliplatin and paclitaxel sequent as HIPEC regimen. The safety and overall survival would be observed and evaluated.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastric Cancer Metastases to Perineum

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HIPEC

Group Type EXPERIMENTAL

Oxaliplatin

Intervention Type DRUG

Oxaliplatin 345mg/m2,43℃，30mins

Paclitaxel

Intervention Type DRUG

Paclitaxel 260mg/m2,43℃，30mins

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oxaliplatin

Oxaliplatin 345mg/m2,43℃，30mins

Intervention Type DRUG

Paclitaxel

Paclitaxel 260mg/m2,43℃，30mins

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histologically proved gastric adenocarcinoma.
* Peritoneum metastasis is observed or suspected by laparoscopy or radiologic examination,or free cancer cells are detected in peritoneal lavage liquid.
* Potentially resectable gastric cancer.
* ALT, AST \< 80U/L; Total Bilirubin \< 30μmol/L; WBC \> 4x10\^9/L; PLT \> 100x10\^9/L; Cr \< 1.5 fold normal value.
* ECOG 0-2 points.
* Expected survival time longer than 3 months.
* Informed consent.

Exclusion Criteria

* Recurrent gastric cancer.
* Pregnant or lactating women.
* Allergic to oxaliplatin or paclitaxel.
* Abnormal liver/kidney function.
* Serious heart/metabolic disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Peking University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jiafu Ji

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jiafu Ji

Role: STUDY_CHAIR

Peking University Cancer Hospital & Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Xiaojiang Wu

Role: CONTACT

Phone: 8601088196598

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HIPEC-GCOT

Identifier Type: -

Identifier Source: org_study_id