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

Phase 3

• Conditions: Survival
• Interventions: Drug: Neoadjuvant chemotherapy; Procedure: D2 radical resection; Drug: Hyperthermic intraperitoneal perfusion chemotherapy; Drug: Adjuvant chemotherapy

• Registration Number: NCT02960061
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief 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.

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 Timeline

• Status Verified: 2016-10
• Study Start: 2016-11
• Study First Submitted: 2016-11-03
• Study First Submitted QC: 2016-11-08
• Last Update Submitted: 2016-11-08
• Study First Posted: 2016-11-09
• Last Update Posted: 2016-11-09
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 640

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIPEC	Adjuvant chemotherapy	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.
HIPEC	Neoadjuvant chemotherapy	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.
HIPEC	D2 radical resection	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.
HIPEC	Hyperthermic intraperitoneal perfusion chemotherapy	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.
controlled group	Neoadjuvant chemotherapy	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.
controlled group	Adjuvant chemotherapy	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.
controlled group	D2 radical resection	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.

Primary Outcome Measures

Name	Time	Method
Number of survival participants will be assessed according to the data collected by the followed up office.	1-5 years

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	1-3 years

Trial Locations

Locations (1)

The sixth affliated hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China