Evaluate the Efficacy of Irinotecan Versus Oxaliplatin in the First-line Treatment of Refractory Metastatic Colorectal Cancer

NCT03567629 | Unknown Phase 2

• 1 other identifier: CSMDT-02
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, open-lable, multicenter, randomized, controlled, phase II clinical study. The aim is to evaluate the efficacy of Irinotecan versus Oxaliplatin in the first-line treatment of refractory metastatic colorectal cancer.

Conditions

mCRC

Keywords

Irinotecan; Oxaliplatin; refractory; mCRC

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first.

  Evaluation of the Progression-free Survival of Irinotecan-based regimen versus Oxaliplatin-based regimen in refractory metastatic colorectal cancer patients.

  assessed up to 10 months

Secondary Outcomes (4)

• Overall Survival : From date of enrollment until the date of death.

  2 years

• Evaluation of PFS in patients with different fluorouracil drugs and different genotyping subgroups.

  10months

• Evaluation of OS in patients with different fluorouracil drugs and different genotyping subgroups.

  2 years

• The incidence of treatment related emergent adverse events（Safety and Tolerance）

  Until 28 days after the deadline of enrollment

Study Arms (2)

Irinotecan-based chemotherapy

EXPERIMENTAL

Drug: Irinotecan

Oxaliplatin-based chemotherapy

ACTIVE COMPARATOR

Drug: Oxaliplatin

Interventions

Irinotecan DRUG

Irinotecan 180 mg / m2, intravenous drip, D1, combined with fluorouracil / calcium folinate or Capecitabine or S1; combine or not combine with Bevacizumab or Cetuximab; every 14 days for a cycle.

Also known as: fluorouracil / calcium folinate, Capecitabine, S1, Bevacizumab, Cetuximab

Irinotecan-based chemotherapy

Oxaliplatin DRUG

Oxaliplatin 85mg/m2 (two-week regimen) or 130mg/m2 (three week regimen), intravenous drip, D1, combined with fluorouracil / calcium folinate or Capecitabine or S1; combine or not combine with Bevacizumab or Cetuximab; every 14 or 21 days for a cycle.

Also known as: fluorouracil / calcium folinate, Capecitabine, S1, Bevacizumab, Cetuximab

Oxaliplatin-based chemotherapy

Eligibility Criteria

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

You may qualify if:

• Histopathological diagnosis of metastatic colorectal adenocarcinoma.
• At least one measurable or assessable lesion that meet RECIST criteria.
• Accord with standard for refractory colorectal cancer (The standard for refractory colorectal cancer can be met if one of the following conditions is met)
• (1) Right colon cancer. (2) Mucinous adenocarcinoma or signet ring cell carcinoma. (3) Complicated by peritoneal metastasis. (4) MSI-H or dMMR, immune checkpoint inhibitor therapy is not acceptable. 4. Male or female, age≥18 years old. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2. 6. Life expectancy \>3 months 7. Adequate organ function as indicated by the following laboratory values:
• Serum total bilirubin ≤ 1.5 X upper limit of the normal (ULN)
• Absolute neutrophil count (ANC) ≥1,500 /µL（1.5×109 /L）
• Platelets ≥100,000 /µL（100×109 /L）
• Hemoglobin ≥9.0 g/dL
• Serum creatinine ≤1.5 X (ULN)
• Prothrombin Time (PT)≤ 1.5 X ULN
• Left ventricular ejection fraction (LVEF)(measured by Doppler ultrasound) is greater than the lower limit of the normal value (LLN) defined by the study center at which the examination was conducted.
• \. Signed the informed consent with name and time. 9. The subjects are accredited with good compliance, and capable to cooperate, completing the relevant examination treatment, and follow-ups.

You may not qualify if:

• Received palliative chemotherapy, such as adjuvant chemotherapy, recurrence within 12 months after adjuvant chemotherapy.
• Metastatic lesion is subject to be treated by local intervention.
• Subjects with BRAF V600E mutation.
• Presence of other active malignancies or a history of other malignancies within the past 5 years, except for carcinoma in situ of the cervix, basal cell carcinoma of the skin that has been previously treated with curative intent.
• Subjects with cerebral metastasis, spinal cord compression, carcinomatous meningitis, CT /MRI examination reveals diseases of the brain or pia mater during screening.
• Subjects with chronic diarrhea, intestinal obstruction or incomplete intestinal obstruction, or severe peripheral nerve disease.
• Any of the following diseases occurred in the 12 months before the study: Myocardial infarction, severe / unstable angina pectoris, coronary artery / peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack, or pulmonary embolism within 6 months
• Subject is known to be infected with Immunodeficiency virus (HIV) or associated with acquired immune deficiency syndrome (AIDS).
• Subject is enrolled in other clinical trials currently.
• Pregnant or lactating women; women of potential childbearing age and male subjects do not use effective contraception during the study period.
• Other severe acute and chronic physiological or mental problems, or abnormal laboratory tests, which may increase the risk of participating in the study or use of drugs, or interfering with the results of the study, and is judged by the researchers that the patient is not suitable for the study.

Sponsors & Collaborators

• Peking University: lead
• Liaoning Cancer Hospital & Institute: collaborator
• Zhejiang University: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Interventions

Irinotecan; Fluorouracil; Leucovorin; Capecitabine; S 1 (combination); Bevacizumab; Cetuximab; Oxaliplatin

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals

Study Officials

• Lin Shen, Professor

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Head of department of Gastrointestinal oncology

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: June 26, 2018
• Study Start: May 29, 2018
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2023
• Last Updated: June 26, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)