Efficacy of HIPEC Combined With Systemic Chemotherapy and CRS on Peritoneal Metastases From Gastric Cancer

NCT03179579 | Unknown Phase 3 DMC

• 1 other identifier: HIPEC-02
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

This project is a multi-center, prospective, randomized controlled clinical observation the safety and efficacy that stage IV limited peritoneal metastasis of gastric cancer patients accept hyperthermic intraperitoneal chemotherapy plus neoadjuvant chemotherapy with CRS and systemic chemotherapy. With advanced-stage gastric patients of confined to the peritoneal as the research object, with median progression-free survival and overall survival, adverse events as the end points.

Conditions

Gastric Cancer; Peritoneal Carcinomatosis

Keywords

Gastric Cancer; Peritoneal Carcinomatosis; Hyperthermic Intraperitoneal Chemotherapy; Systemic Chemotherapy; Cytoreductive Surgery

Outcome Measures

Primary Outcomes (1)

• Median overall survival

  assess median overall survival rate during 3 years in both study arms

  3 years

Secondary Outcomes (1)

• Risk factors for morbidity and mortality

  Through study completion, an average of 1 year.

Study Arms (2)

Experimental group

EXPERIMENTAL

1. HIPEC with paclitaxel 135 mg/m\^2+HIPEC with cisplatin 75 mg/m\^2±HIPEC with Raltitrexed 3 mg/m\^2 intraperitoneally in succession 2. 2 cycles of neoadjuvant chemotherapy: S-1 40-60 mg/m\^2, d1-d14, Bid p.o.+ oxaliplatin 130 mg/m\^2, d1, IV, every 3 weeks 3. Cytoreductive surgery 4. HIPEC with paclitaxel 135 mg/m\^2+HIPEC with cisplatin 75 mg/m\^2±HIPEC with Raltitrexed 3 mg/m\^2 intraperitoneally in succession 5. 4-6 cycles of adjuvant chemotherapy: S-1 40-60 mg/m\^2, d1-d14, Bid p.o.+ oxaliplatin 130 mg/m\^2, d1, IV, every 3 weeks

Procedure: HIPEC with neoadjuvant chemotherapy

Control group

ACTIVE COMPARATOR

1. 3 cycles of neoadjuvant chemotherapy: S-1 40-60 mg/m\^2, d1-d14, Bid p.o.+ oxaliplatin 130 mg/m\^2, d1, IV, every 3 weeks 2. Cytoreductive surgery 3. 4-6 cycles of adjuvant chemotherapy: S-1 40-60 mg/m\^2, d1-d14, Bid p.o.+ oxaliplatin 130 mg/m\^2, d1, IV, every 3 weeks

Procedure: Systemic chemotherapy

Interventions

HIPEC with neoadjuvant chemotherapy PROCEDURE

HIPEC 3 times +NACT 2 cycles +CRS +HIPEC 3 times+ ACT 4-6 cycles

Also known as: CRS with HIPEC and adjuvant cheomtherapy

Experimental group

Systemic chemotherapy PROCEDURE

NACT 3 cycles +CRS +ACT 4-6 cycles

Also known as: CRS with systemic chemotherpay

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gastic adenocarcinoma is diagnosed by histological and cytological examination.
• Peritoneal carcinomastosis of gastric cancer is diagnosed by laparotomy or laparoscopic exploration.
• According to Sugarbaker's peritoneal cancer index (PCI), PCI score of participant is no more than 20.
• \< Age \< 70 year old
• Expected survival \> 3 months
• Performance status: ECOG 0-1
• Adequate bone marrow function Hb ≥9 g/dl (After correction in case of iron deficient anemia) WBC ≥ 3,500/mm3, Platelet ≥ 100,000/mm3
• Adequate renal function Creatinine ≤ 1.5 mg/dl, and adequate hepatic function Bilirubin ≤ 1.5 mg/dl and AST and ALT ≤ 2.5×ULN
• \. Voluntary participation after getting written informed consent.

You may not qualify if:

• Except for peritoneal carcinomatosis, gastric cancer concurrently metastasized to liver, lung, para-aortic lymph node and other distant organs.
• Extensive adhesion in peritoneal cavity
• Previous History of other malignancies
• Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction\<50%
• Receiving other chemotherapy, radiotherapy or immunotherapy
• Patients who are unsuitable candidates by doctor's decision
• Without given written informed consent

Sponsors & Collaborators

• Shu-Zhong Cui: lead
• Tianjin Medical University Cancer Institute and Hospital: collaborator
• Chinese PLA General Hospital: collaborator
• Harbin Medical University: collaborator
• Southern Medical University, China: collaborator
• Guangdong Provincial People's Hospital: collaborator
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator

Study Sites (1)

Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510095, China

Location

MeSH Terms

Conditions

Stomach Neoplasms; Peritoneal Neoplasms

Interventions

Hyperthermic Intraperitoneal Chemotherapy; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Abdominal Neoplasms; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Officials

• Shu-Zhong Cui, M.D

  Affiliated Cancer Hospital & Institute of Guangzhou Medical University

  STUDY CHAIR

Central Study Contacts

Xian-Zi Yang, M.D

CONTACT

8602066673666; 7097359@qq.com

Zhen Tang, M.M

CONTACT

8602066673666; tangzhentangmin@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President of Affiliated Tumor Hospital of Guangzhou Medical

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 7, 2017
• Study Start: August 1, 2017
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2022
• Last Updated: June 7, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)