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Trial record 43 of 159 for:    colon cancer AND Capecitabine AND Fluorouracil

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03567629
Recruitment Status : Active, not recruiting
First Posted : June 25, 2018
Last Update Posted : June 25, 2018
Sponsor:
Collaborators:
Liaoning Tumor Hospital & Institute
Zhejiang University
Information provided by (Responsible Party):
Shen Lin, Peking University

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.

Condition or disease Intervention/treatment Phase
mCRC Drug: Irinotecan Drug: Oxaliplatin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 29, 2018
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine


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:
  • fluorouracil / calcium folinate
  • Capecitabine
  • S1
  • Bevacizumab
  • Cetuximab

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:
  • fluorouracil / calcium folinate
  • Capecitabine
  • S1
  • Bevacizumab
  • Cetuximab




Primary Outcome Measures :
  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. [ 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.


Secondary Outcome Measures :
  1. 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. Evaluation of PFS in patients with different fluorouracil drugs and different genotyping subgroups. [ Time Frame: 10months ]
    flurouracil drugs:fluorouracil、S1、Capecitabine

  3. Evaluation of OS in patients with different fluorouracil drugs and different genotyping subgroups. [ Time Frame: 2 years ]
    flurouracil drugs:fluorouracil、S1、Capecitabine

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567629


Locations
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China, Beijing
Beijing Cancer Hospital
Beijing, Beijing, China, 100142
Sponsors and Collaborators
Peking University
Liaoning Tumor Hospital & Institute
Zhejiang University
Investigators
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Principal Investigator: Lin Shen, Professor Beijing Cancer Hospital

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site

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Responsible Party: Shen Lin, Head of Head of department of Gastrointestinal oncology, Peking University
ClinicalTrials.gov Identifier: NCT03567629     History of Changes
Other Study ID Numbers: CSMDT-02
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shen Lin, Peking University:
Irinotecan
Oxaliplatin
refractory
mCRC
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Capecitabine
Fluorouracil
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Calcium, Dietary
Leucovorin
Bevacizumab
Cetuximab
Oxaliplatin
Irinotecan
Calcium
Levoleucovorin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents