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

NCT ID: NCT04358354

Last Updated: 2021-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 388 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-22
• Study Completion Date: 2024-12-31

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.

Detailed Description

Eligible patients will be randomly assigned to FOLFOXiri group and FOLFOX group. Stratification factors include ECOG PS, disease extent and pathological subtypes. Efficacy will be evaluated every 3-4 cycles with RECIST. Toxicity will be assessed with WHO CTC 3.0 every 2 weeks.

Conditions

Metastatic Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FOLFOXiri group

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.

Group Type: EXPERIMENTAL

Irinotecan

Intervention Type: DRUG

Irinotecan 150 mg/m2

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin 85 mg/m2

5-fluorouracil

Intervention Type: DRUG

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

FOLFOX group

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.

Group Type: ACTIVE_COMPARATOR

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin 85 mg/m2

5-fluorouracil

Intervention Type: DRUG

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

Interventions

Irinotecan

Irinotecan 150 mg/m2

Intervention Type: DRUG

Oxaliplatin

Oxaliplatin 85 mg/m2

Intervention Type: DRUG

5-fluorouracil

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

Intervention Type: DRUG

Other Intervention Names

CPT-11; LOHP; 5-FU

Eligibility Criteria

Inclusion Criteria

1. Age 18-75 years old, gender is not limited;

2. Inoperable locally advanced, recurrent, and/or metastatic cancer of the stomach or gastro-esophageal junction;

3. Pathologically confirmed adenocarcinoma;

4. Expected survival time ≥ 3 months;

5. ECOG PS 0-3;

6. 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;

7. 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;

8. Be able to understand the research process, volunteer to participate in the study, and sign an informed consent form.

Exclusion Criteria

1. Patients known to be allergic to active or other components of chemotherapeutic drugs;

2. Patients with severe peritoneal dissemination and GI obstruction;

3. Her-2 overexprssion or d-MMR;

4. Severe or uncontrolled infections that may affect the evaluation of the study treatment or study results;

5. History of other malignant tumors in the past 5 years (except for cured cervical carcinoma in situ or basal cell carcinoma of the skin);

6. Participated in other clinical trials within 4 weeks prior to the start of the study;

7. Pregnant or lactating women, or women of childbearing age who refuse to take effective contraception during the study period.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Jian Xiao

Asso. Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jian Xiao, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaohui Zhai, MD, PhD

Role: CONTACT

zhaixh@mail.sysu.edu.cn

86-20-38285497

Shanshan Li, MD

Role: CONTACT

lishsh89@163.com

86-20-38285497

Facility Contacts

Xiaohui Zhai, MD

Role: primary

zhaixh@mail.sysu.edu.cn

Other Identifiers

SAHMO206

Identifier Type: -

Identifier Source: org_study_id