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Perioperative Chemotherapy Combined With HIPEC for High-risk Advanced Gastric Cancer

NCT02960061 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 640

Last updated 2016-11-09

No results posted yet for this study

Summary

The investigators intend to conduct a randomized controlled study to find if combining HIPEC (hyperthermic intraperitoneal perfusion chemotherapy) with post-neoadjuvant chemotherapy D2 resection could improve survival for patients with advanced gastric cancer, while comparing with the traditional approach of D2 resection after neoadjuvant chemotherapy.

Conditions

  • Survival

Interventions

DRUG

Neoadjuvant chemotherapy

Eligible patients receive 4 cycles of mDOF(docetaxel 50 mg/ m2 day 1 + oxaliplatin 85 mg/ m2 day 2 + fluorouracil 400 mg/ m2 bolus iv followed by 600 mg/ m2 22 hours chronic infusion, day 2/3 + leucovorin 200 mg/ m2, day2/3; repeated every 14 days ).

PROCEDURE

D2 radical resection

Laparotomy or laparoscopic surgery are chosen according to the preference of the surgeon. Either cases, a throughout peritoneal cavity exploration is required to comfirmed the tumor resectability and peritoneal metastasis. A curative D2 resection is performed if achievable.

DRUG

Hyperthermic intraperitoneal perfusion chemotherapy

Two cycle of hyperthermic intraperitoneal perfusion chemotherapy is administered to patients who have received neoadjuvant chemotherapy and D2 resection, dosage and the relative parameter setting is described above.

DRUG

Adjuvant chemotherapy

Adjuvant chemotherapy using SOX or XELOX regimen will be administered as routine within 4-6 weeks.

Sponsors & Collaborators

  • Sixth Affiliated Hospital, Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Jun-Sheng Peng, PhD · The sixth affliated hospital of Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02960061 on ClinicalTrials.gov