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Trial record 60 of 159 for:    colon cancer AND Capecitabine AND Fluorouracil

Effect of GM1 in Prevention of Oxaliplatin Induced Neurotoxicity in Stage II/III Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT02251977
Recruitment Status : Completed
First Posted : September 29, 2014
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
Yuhong Li, Sun Yat-sen University

Brief Summary:
The primary objective of this study is to assess the efficacy of monosialotetrahexosylganglioside (GM1) for preventing oxaliplatin induced neurotoxicity in colorectal cancer patients who received oxaliplatin-based adjuvant chemotherapy.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Chemotherapy-induced Neutropenia Drug: GM1 Drug: placebo Drug: mFOLFOX6 or XELOX Phase 3

Detailed Description:
Oxaliplatin is a key agent in the treatment of colorectal cancer. However, peripheral neuropathy markedly limits the use of oxaliplatin. Many drugs have been tried to decrease the development of oxaliplatin induced peripheral neurotoxicity, however, the results remain disappointing. This multi-center, randomized, placebo-controlled trial was performed to assess the efficacy of monosialotetrahexosylganglioside (GM1) for preventing oxaliplatin induced neurotoxicity in colorectal cancer patients who received oxaliplatin-based adjuvant chemotherapy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Monosialotetrahexosylganglioside (GM1) in Prevention of Oxaliplatin Induced Neurotoxicity in Colorectal Cancer Patients Who Received Oxaliplatin-based Adjuvant Chemotherapy: A Multi-center, Randomized, Placebo-controlled Trial
Study Start Date : September 2014
Actual Primary Completion Date : September 5, 2017
Actual Study Completion Date : September 5, 2017


Arm Intervention/treatment
Experimental: Adjuvant Chemotherapy plus GM1
Patients will receive mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) or XELOX (capecitabine and oxaliplatin) for adjuvant chemotherapy. While GM1 will be delivered to patients through the day before the initiation of chemotherapy (Day0) to the completion of chemotherapy (Day4), and the dosages of GM1 for patients who receive mFOLFOX6 or XELOX are 80mg or 120mg per day.
Drug: GM1
GM1 will be delivered to patients through the day before the initiation of chemotherapy (Day0) to the completion of chemotherapy (Day4), and the dosages of GM1 for patients who receive mFOLFOX6 or XELOX are 80mg or 120mg per day.
Other Name: monosialotetrahexosylganglioside

Drug: mFOLFOX6 or XELOX

mFOLFOX6: Patients will receive mFOLFOX6 every 14 days, Oxaliplatin 85mg/m2 IV over 3 hours on Day1; Calcium Folinate IV over 2h on Day 1(Leucovorin 200mg/m2 or CF 400 mg/m2); 5-Fluorouracil 400mg/m2 IV on Day1; followed by 5-Fluorouracil 2.4g/m2 for 46 hours continuous infusion on Day1.

XELOX: Patients will receive XELOX every 21 days, Oxaliplatin 130mg/m2 IV over 3 hours on Day1;followed by Capecitabine 1000mg/m2 oral twice daily for 14 days.

The optimum chemotherapy regimen is at the discretion of the investigators based on the condition of each patient.

Other Names:
  • Oxalipaltin
  • Leucovorin
  • Calcium Folinate
  • 5-Fluorouracil
  • Capecitabine

Placebo Comparator: Adjuvant Chemotherapy plus placebo
Patients will receive mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) or XELOX (capecitabine and oxaliplatin) for adjuvant chemotherapy. While placebo will be delivered to patients through the day before the initiation of chemotherapy (Day0) to the completion of chemotherapy (Day4).
Drug: placebo
Placebo will be delivered to patients through the day before the initiation of chemotherapy (Day0) to the completion of chemotherapy (Day4), and the dosages of placebo for patients who receive mFOLFOX6 or XELOX are 80mg or 120mg per day.

Drug: mFOLFOX6 or XELOX

mFOLFOX6: Patients will receive mFOLFOX6 every 14 days, Oxaliplatin 85mg/m2 IV over 3 hours on Day1; Calcium Folinate IV over 2h on Day 1(Leucovorin 200mg/m2 or CF 400 mg/m2); 5-Fluorouracil 400mg/m2 IV on Day1; followed by 5-Fluorouracil 2.4g/m2 for 46 hours continuous infusion on Day1.

XELOX: Patients will receive XELOX every 21 days, Oxaliplatin 130mg/m2 IV over 3 hours on Day1;followed by Capecitabine 1000mg/m2 oral twice daily for 14 days.

The optimum chemotherapy regimen is at the discretion of the investigators based on the condition of each patient.

Other Names:
  • Oxalipaltin
  • Leucovorin
  • Calcium Folinate
  • 5-Fluorouracil
  • Capecitabine




Primary Outcome Measures :
  1. rates of grade 2 or more chronic cumulative neurotoxicity of both arms [ Time Frame: 9 months ]
    measured by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0, with standardized questions regarding neurotoxic symptoms and examples of answers


Secondary Outcome Measures :
  1. rates of chronic cumulative neurotoxicity of both arms [ Time Frame: 9 months ]
    measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20

  2. time to grade 2 or more neurotoxicity of both arms [ Time Frame: 9 months ]
  3. rates of dose reduction or withdrawal due to oxaliplatin induced neurotoxicity of both arms [ Time Frame: 9 months ]
  4. rates of acute neurotoxicity of both arms [ Time Frame: 6 months ]
    measured by a numerical analog scale ranging from 0 to 10 that addressed sensitivity touching cold items, discomfort swallowing cold items, throat discomfort, and muscle cramps

  5. rates and grades of adverse reactions of both arms [ Time Frame: 6 months ]
  6. rates of 3 year disease free survival of both arms [ Time Frame: 3 years ]

Other Outcome Measures:
  1. change degrees of the levels of nerve growth factor and other neurotrophic factors of both arms [ Time Frame: 6 months ]
  2. genetic polymorphisms of oxaliplatin induced severe and cumulative neurotoxicity [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 18-75 years old, male or female
  • Histologically confirmed diagnosis of colorectal adenocarcinoma with a phase II or III disease, within 2 months from radical resection, and intends to receive 6 months of adjuvant chemotherapy with mFOLOFX6 or XELOX, without adjuvant radiation indications
  • No prior any level of peripheral nerve system disease
  • Patients have not received any other possible neurotoxic-reaction-causing drugs (such as oxaliplatin, cisplatin and paclitaxel drugs etc)
  • With the capability to accurately record the occurrence and severity of neurotoxicity by questionnaire
  • With normal functions of major organs
  • No contraindication to chemotherapy
  • Life expectancy ≥ 3 months
  • Patients have provided a signed Informed Consent Form

Exclusion Criteria:

  • Patients who received radical resection, but are expected not be able to complete 6 months of adjuvant chemotherapy
  • Patients who receive palliative chemotherapy
  • Patients who need adjuvant or palliative radiotherapy during chemotherapy
  • Be allergic to GM1
  • Hereditary abnormal metabolism of glucose and lipid
  • Doctors believe that patients are not suitable for receiving GM1 treatment
  • With confirmed history of neurological or psychiatric disorders, including epilepsy and dementia
  • With concomitant diseases that will seriously harm the patients' safety or impact the completion of the study
  • Patients (male or female) have fertility possibility but not willing or not to take effective contraceptive measures

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): NCT02251977


Locations
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China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Yuhong Li
Investigators
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Principal Investigator: Yuhong Li, MD Sun Yat-sen University

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Responsible Party: Yuhong Li, MD Ph D, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02251977     History of Changes
Other Study ID Numbers: GOXL-18
First Posted: September 29, 2014    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
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
Neurotoxicity Syndromes
Neutropenia
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Nervous System Diseases
Poisoning
Chemically-Induced Disorders
Leucovorin
Oxaliplatin
Calcium
Levoleucovorin
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites