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

November 8, 2016 updated by: Sixth Affiliated Hospital, Sun Yat-sen University

D2 Radical Resection After Neoadjuvant Chemotherapy Combined With HIPEC for Advanced Gastric Cancer: a Prospective Randomized Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Gastric cancer, as the second common malignant tumors in china, is marked by its poor prognosis and high recurrent rate. Although R0 resection could be achieved in most advanced gastric cancer(AGC) patients without metastasis, age-standardized 5-years survival rate was no more than 27.4%. Peritoneal metastasis accounts for 50% of the recurrent case and remain to be the most fatal recurrence pattern.

Hyperthermic intraperitoneal perfusion chemotherapy ( HIPEC ), has been proved as one of the most efficient approach against peritoneal carcinomatosis from gastric cancer and recommended in the guideline for gastric cancer published by the health committee of china. However, its role as prophylactic treatment after curative has never been determined. HIPEC works by delivering heat and cytotoxic drug to the cancer cell and is more effective on the tumor with small size. As present study suggest that Peritoneal metastasis is related to lymph node dissection during surgery while opening lymphatic channels and spreading viable cancer cells into the peritoneal cavity, HIPEC might be a reasonable approach to destroy the remaining cancer cells after curative surgery. Thus this research aim to explore the efficacy and safety of combining HIPEC (hyperthermic intraperitoneal perfusion chemotherapy) with post-neoadjuvant chemotherapy D2 resection.

Study Type

Interventional

Enrollment (Anticipated)

640

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • The sixth affliated hospital of Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. First diagnosed as gastric cancer by pathological examination;
  2. No previous chemotherapy or radiotherapy;
  3. T stage:3-4, N stage: 1-3, M stage: 0, assessed by CT or ultrasound endoscope;
  4. Eastern Cooperative Oncology Group performance status (ECOG PS): 0-1;
  5. Informed consent signed;

Exclusion Criteria:

  1. Other malignancy within 5 years.
  2. Peritoneal metastasis detected during surgery.
  3. Pregnant or lactating women;
  4. Patients with conditions requiring emergency surgery;
  5. Tumor progress during neo-adjuvant chemotherapy
  6. Severe, uncontrolled physical or metal disease.
  7. Poor compliance.
  8. Uncontrolled infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HIPEC
After receiving neoadjuvant chemotherapy and D2 radical resection, Hyperthermic intraperitoneal perfusion chemotherapy is conducted,4 catheters are placed in 4 position in the peritoneal cavity: ① under the left diaphragm ② hepatorenal recess ③ left pelvis ④ right pelvis.catheters, all four tubes are connected to the perfusion device.Perfusion prescription: cycle 1, Paclitaxel 75mg/ m2 diluted with 3000ml normal saline heated up to a fixed temperature of 43°C circulate continuously for 60min at a speed of 400-500ml/h; cycle 2 start within 24-48 hours after cycle 1, dosage of paclitaxel adjust to 100mg/ m2, the rest of the same. A total of two cycle is administered, routine adjuvant chemotherapy using SOX (oxaliplatin plus S-1 capsule)or XELOX regimens follows within 4-6 weeks.
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.
Sham Comparator: controlled group
After receiving neoadjuvant chemotherapy and D2 radical resection, patients receive peritoneal lavage with 3000ml distilled water.Adjuvant chemotherapy using SOX or XELOX regimens is administered as routine within 4-6 weeks.
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: Adjuvant chemotherapy
Adjuvant chemotherapy using SOX or XELOX regimen will be administered as routine within 4-6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of survival participants will be assessed according to the data collected by the followed up office.
Time Frame: 1-5 years
1-5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: 1-3 years
1-3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

November 3, 2016

First Submitted That Met QC Criteria

November 8, 2016

First Posted (Estimate)

November 9, 2016

Study Record Updates

Last Update Posted (Estimate)

November 9, 2016

Last Update Submitted That Met QC Criteria

November 8, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIPEC-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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