Clinical trial NCT02960061: Perioperative Chemotherapy Combined With HIPEC for High-risk Advanced Gastric Cancer
Official title: D2 Radical Resection After Neoadjuvant Chemotherapy Combined With HIPEC for Advanced Gastric Cancer: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Survival
Keywords: Intraperitoneal chemotherapy
gastric cancer
Neo-adjuvant chemotherapy
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-11-09
Enrollment: 640
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of survival participants will be assessed according to the data collected by the followed up office.
timeFrame: 1-5 years
Secondary outcomes:
measure: Progression Free Survival
timeFrame: 1-3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The sixth affliated hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: The sixth affliated hospital of Sun Yat-sen University
name: Jun-Sheng Peng, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marutsuka T, Shimada S, Shiomori K, Hayashi N, Yagi Y, Yamane T, Ogawa M. Mechanisms of peritoneal metastasis after operation for non-serosa-invasive gastric carcinoma: an ultrarapid detection system for intraperitoneal free cancer cells and a prophylactic strategy for peritoneal metastasis. Clin Cancer Res. 2003 Feb;9(2):678-85.
citation: Lin CH, Hsieh HF, Yu JC, Chen TW, Yu CY, Hsieh CB. Peritoneal lavage with distilled water during liver resection in patients with spontaneously ruptured hepatocellular carcinomas. J Surg Oncol. 2006 Sep 1;94(3):255-6. doi: 10.1002/jso.20596.
citation: Yonemura Y, de Aretxabala X, Fujimura T, Fushida S, Katayama K, Bandou E, Sugiyama K, Kawamura T, Kinoshita K, Endou Y, Sasaki T. Intraoperative chemohyperthermic peritoneal perfusion as an adjuvant to gastric cancer: final results of a randomized controlled study. Hepatogastroenterology. 2001 Nov-Dec;48(42):1776-82.
citation: Hamazoe R, Maeta M, Kaibara N. Intraperitoneal thermochemotherapy for prevention of peritoneal recurrence of gastric cancer. Final results of a randomized controlled study. Cancer. 1994 Apr 15;73(8):2048-52. doi: 10.1002/1097-0142(19940415)73:83.0.co;2-q.