Nonintervention Study on Peritoneal Metastasis of Stage IV Gastric Cancer

NCT03237507 | Unknown FDA Drug

• 1 other identifier: TOTPMSG1602
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This is a non-interventional study，aim to observe the safety and efficiency of different treatment regimen for peritoneal metastasis of Stage IV gastric cancer in the real world

Conditions

Stage IV Gastric Cancer With Metastasis

Outcome Measures

Primary Outcomes (1)

• PFS: Progression Free Survival

  time from enrollment to disease progression or death

  through study completion, an average of 1 year

Secondary Outcomes (2)

• OS:overall survival

  3 years

• Safety

  3 years

Study Arms (2)

Chemotherapy Group

chemotherapy treatment（S-1 and Oxaliplatin） for patients until disease progress

Drug: S-1; Drug: oxaliplatin

Chemotherapy plus HIPEC Group

Hyperthermic Intraperitoneal chemoperfusion（HIPEC）with Paclitaxel more than 2 cycles and plus chemotherapy

Drug: S-1; Drug: oxaliplatin; Device: Hyperthermic Intraperitoneal; Drug: Paclitaxel

Interventions

S-1 DRUG

40-60mg/m\^2 bid, days 1-14, oral，every 3 weeks.

Chemotherapy Group; Chemotherapy plus HIPEC Group

oxaliplatin DRUG

100mg/m\^2 days 1，intravenous infusion, every 3 weeks.

Chemotherapy Group; Chemotherapy plus HIPEC Group

Hyperthermic Intraperitoneal DEVICE

hyperthermic intraperitoneal chemoperfusion

Chemotherapy plus HIPEC Group

Paclitaxel DRUG

intraperitoneal perfusion

Chemotherapy plus HIPEC Group

Eligibility Criteria

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

Study Population

Patients with histologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma, stage IV with peritoneal metastasis

You may qualify if:

• ≤ age
• Patients with histologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma, stage IV with peritoneal metastasis
• Didn't received any prior systemic chemotherapy
• Signed informed consent

You may not qualify if:

• History of hypersensitivity to fluoropyrimidines, Tegafur，Gimeracil and Oteracil Potassium Capsules , capecitabine, oxaliplatin or the ingredients of this product
• Pregnancy or lactation women,
• Inadequate hematopoietic function： WBC≦3,500/mm3; ANC≦1,500/mm3; Platelet≦80,000/mm3
• Inadequate organ function which is defined as below:
• Total bilirubin \>2 pper limit of normal range (ULN); ALT / AST \> 2.5 upper limit of normal range (ULN); serum creatinine \> 1.5 mg/dL, and Ccr \> 60 ml/min (estimated by Cockcroft-Gault formulation);
• Symptomatic peripheral neuropathy
• Receiving a concomitant treatment with other fluoropyrimidines
• Fluoropyrimidines (DPD) congenital absence
• Other Situations which physicians suggesting are inadaptable for enrollment

Sponsors & Collaborators

• Harbin Medical University: lead

Study Sites (1)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

Location

MeSH Terms

Interventions

S 1 (combination); Oxaliplatin; Hyperthermic Intraperitoneal Chemotherapy; Paclitaxel

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Kuan Wang

  Harbin Medical University Cancer Hospital,Gastrointestinal Surgical department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 2, 2017
• Study Start: July 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2020
• Last Updated: August 2, 2017

Record last verified: 2017-07

Locations

CN (1)