Triplet Combination of Cytotoxics as First-line Treatment for Metastatic Gastric Cancer

NCT04358354 | Unknown Phase 3

• 1 other identifier: SAHMO206
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 1

Brief Summary

This parallel, randomized, open-label study will evaluate the effect on overall survival of irinotecan on oxaliplatin and 5-fluorouracil (5-FU) in patients with HER2-negative and pMMR metastatic gastric cancer. Irinotecan will be administered as intravenous infusion of 150 mg/m2 every 2 weeks. Oxaliplatin will be given 85 mg/m2 and 5-FU will be given 400mg/m2 iv and 2400mg/m2 civ 48 hours fortnightly. Treatment will continue until disease progress or untolerable toxicity appears. The target sample size is 350-400 patients.

Conditions

Metastatic Gastric Cancer

Keywords

irinotecan

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  OS is defined as the time from the date of randomization to the date of death due to any cause. Participants were censored at the last date of tumor measurement, the last date in the study drug log or the date of last follow-up.

  2 years

Secondary Outcomes (6)

• Progression-Free Survival (PFS)

  1 year

• Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Determined by Response Evaluation Criteria in Solid Tumors (RECIST)

  24 weeks

• Duration of Response

  1 year

• European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores

  2 years

• EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores

  2 years

Study Arms (2)

FOLFOXiri group

EXPERIMENTAL

Irinotecan 150 mg/m2 iv drip d1; Oxaliplatin 85 mg/m2 iv drip d1; LV 200 mg/m2 iv drip d1; 5FU 400mg/m2 iv bolus and 2400 mg/m2 civ; The regimen will be repeated every 2 weeks until disease progression or untolerable toxicity.

Drug: Irinotecan; Drug: Oxaliplatin; Drug: 5-fluorouracil

FOLFOX group

ACTIVE COMPARATOR

Oxaliplatin: 85 mg/m2 iv drip d1; LV 200 mg/m2 iv drip d1; 5FU 400mg/m2 iv bolus and 2400 mg/m2 civ 46h; The regimen will be repeated every 2 weeks until disease progression or untolerable toxicity.

Drug: Oxaliplatin; Drug: 5-fluorouracil

Interventions

Irinotecan DRUG

Irinotecan 150 mg/m2

Also known as: CPT-11

FOLFOXiri group

Oxaliplatin DRUG

Oxaliplatin 85 mg/m2

Also known as: LOHP

FOLFOX group; FOLFOXiri group

5-fluorouracil DRUG

5-fluorouracil 400 mg/m2 iv bolus and 2400 mg/m2 civ 46 hours

Also known as: 5-FU

FOLFOX group; FOLFOXiri group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years old, gender is not limited;
• Inoperable locally advanced, recurrent, and/or metastatic cancer of the stomach or gastro-esophageal junction;
• Pathologically confirmed adenocarcinoma;
• Expected survival time ≥ 3 months;
• ECOG PS 0-3;
• Adequate bone marrow function reserve: white blood cell count ≥ 3.0 × 10\*9 / L, neutrophil count ≥ 1.5 × 10\*9/ L; platelet count ≥ 100 ×10\*9/ L; hemoglobin ≥ 90 g / L;
• AST and ALT ≤ 2.5 times the upper limit of normal value, total bilirubin ≤ 2 times the upper limit of normal value; serum creatinine ≤ 1.5 times the upper limit of normal value;
• Be able to understand the research process, volunteer to participate in the study, and sign an informed consent form.

You may not qualify if:

• Patients known to be allergic to active or other components of chemotherapeutic drugs;
• Patients with severe peritoneal dissemination and GI obstruction;
• Her-2 overexprssion or d-MMR;
• Severe or uncontrolled infections that may affect the evaluation of the study treatment or study results;
• History of other malignant tumors in the past 5 years (except for cured cervical carcinoma in situ or basal cell carcinoma of the skin);
• Participated in other clinical trials within 4 weeks prior to the start of the study;
• Pregnant or lactating women, or women of childbearing age who refuse to take effective contraception during the study period.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Irinotecan; Oxaliplatin; Fluorouracil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Jian Xiao, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaohui Zhai, MD, PhD

CONTACT

86-20-38285497; zhaixh@mail.sysu.edu.cn

Shanshan Li, MD

CONTACT

86-20-38285497; lishsh89@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asso. Professor

Study Record Dates

• First Submitted: April 11, 2020
• First Posted: April 24, 2020
• Study Start: October 22, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: July 19, 2021

Record last verified: 2021-07

Locations

CN (1)