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

June 21, 2018 updated by: Shen Lin, Peking University

A Prospective, Open-lable, Multicenter, Randomized, Controlled Phase II Clinical Trial to Evaluate the Efficacy of Irinotecan Versus Oxaliplatin in the First-line Treatment of Refractory Metastatic Colorectal Cancer

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This trial is conducted in patients with the refractory metastatic colorectal cancer. Eligible patients are randomized into two arms at 1:1 ratio to receive Irinotecan-based regimen or Oxaliplatin-based regimen until progress of the disease, unacceptable toxicity or withdrawal of consent by the patient. Study evaluation time is until death of patient or a deadline set by the researchers.

Study Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Beijing Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histopathological diagnosis of metastatic colorectal adenocarcinoma.
  2. At least one measurable or assessable lesion that meet RECIST criteria.
  3. 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:

  1. Serum total bilirubin ≤ 1.5 X upper limit of the normal (ULN)
  2. Absolute neutrophil count (ANC) ≥1,500 /µL（1.5×109 /L）
  3. Platelets ≥100,000 /µL（100×109 /L）
  4. Hemoglobin ≥9.0 g/dL
  5. Serum creatinine ≤1.5 X (ULN)
  6. Prothrombin Time (PT)≤ 1.5 X ULN
  7. 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.

8. 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.

Exclusion Criteria:

  1. Received palliative chemotherapy, such as adjuvant chemotherapy, recurrence within 12 months after adjuvant chemotherapy.
  2. Metastatic lesion is subject to be treated by local intervention.
  3. Subjects with BRAF V600E mutation.
  4. 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.
  5. Subjects with cerebral metastasis, spinal cord compression, carcinomatous meningitis, CT /MRI examination reveals diseases of the brain or pia mater during screening.
  6. Subjects with chronic diarrhea, intestinal obstruction or incomplete intestinal obstruction, or severe peripheral nerve disease.
  7. 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
  8. Subject is known to be infected with Immunodeficiency virus (HIV) or associated with acquired immune deficiency syndrome (AIDS).
  9. Subject is enrolled in other clinical trials currently.
  10. Pregnant or lactating women; women of potential childbearing age and male subjects do not use effective contraception during the study period.
  11. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Irinotecan-based chemotherapy
Drug: Irinotecan
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.
Other Names:
  • Capecitabine
  • Bevacizumab
  • Cetuximab
  • S1
  • fluorouracil / calcium folinate
ACTIVE_COMPARATOR: Oxaliplatin-based chemotherapy
Drug: Oxaliplatin
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.
Other Names:
  • Capecitabine
  • Bevacizumab
  • Cetuximab
  • S1
  • fluorouracil / calcium folinate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first.
Time Frame: assessed up to 10 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of treatment related emergent adverse events（Safety and Tolerance）
Time Frame: Until 28 days after the deadline of enrollment
Adverse reactions evaluation is based on the National Cancer Institute adverse event General terminology Standard [CTCAE] 4.0 version
Until 28 days after the deadline of enrollment
Overall Survival : From date of enrollment until the date of death.
Time Frame: 2 years
Evaluation of the Overall Survival of Irinotecan-based regimen versus Oxaliplatin-based regimen in refractory metastatic colorectal cancer patients.
2 years
Evaluation of PFS in patients with different fluorouracil drugs and different genotyping subgroups.
Time Frame: 10months
flurouracil drugs：fluorouracil、S1、Capecitabine
10months
Evaluation of OS in patients with different fluorouracil drugs and different genotyping subgroups.
Time Frame: 2 years
flurouracil drugs：fluorouracil、S1、Capecitabine
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Collaborators

Zhejiang University
Liaoning Tumor Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 29, 2018

Primary Completion (ANTICIPATED)

December 30, 2021

Study Completion (ANTICIPATED)

December 30, 2023

Study Registration Dates

First Submitted

June 12, 2018

First Submitted That Met QC Criteria

June 21, 2018

First Posted (ACTUAL)

June 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 26, 2018

Last Update Submitted That Met QC Criteria

June 21, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSMDT-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Individual Participant Data Set

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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