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The Effect of Low Molecular Weight Heparin on Survival in Patients With Advanced Colorectal Cancer (LMWHCR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Fudan University
Sponsor:
Information provided by (Responsible Party):
Xu jianmin, Fudan University
ClinicalTrials.gov Identifier:
NCT01972490
First received: September 23, 2013
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to investigate the efficacy and safety of low-molecular-weight heparin in the prevention of venous thromboembolism and improvement of disease-free survival in patients after surgery for colorectal cancer.


Condition Intervention Phase
Colorectal Neoplasms
Drug: Nadroparin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of The Effect of Low Molecular Weight Heparin on Survival in Patients With Advanced Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • the rate of venous thromboembolism, the rate of major and minor bleeding [ Time Frame: 1 month after the operation ] [ Designated as safety issue: Yes ]

    Venous thromboembolism: symptomatic deep vein thrombosis, pulmonary embolism. Major bleeding: an overt bleeding which was fatal, occurred in a critical organ.

    Minor bleeding: any overt bleeding that required a medical intervention and did not meet any of the criteria for major bleeding.



Secondary Outcome Measures:
  • 3 years disease-free survival [ Time Frame: 3 years after operation of colorectal cancer ] [ Designated as safety issue: Yes ]
    PFS will be defined as the period from the first day of CRC resection to local or distant(i.e. metastasis) disease recurrence or death.

  • overall survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    OS will be calculated from randomization to death from any cause or the date of the last follow-up, at which point the data will be censored.


Estimated Enrollment: 300
Study Start Date: June 2009
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARM A
Low-molecular-weight heparin (nadroparin 5000IU)was injected by subcutaneous injections for 7 days after surgery daily.
Drug: Nadroparin
nadroparin 5000IU/day was injected by subcutaneous injections for 7 days after surgery.
Other Name: one kind of low molecular weight heparin
Placebo Comparator: ARM B
Placebo (NS) was injected by subcutaneous injections for 7 days after surgery daily.
Drug: Placebo

Detailed Description:

A consecutive patients after surgery for colorectal cancer from ZhongShan hospital, Fudan university were enrolled and randomly assigned to taking low-molecular-weight or placebo. Post-operative formation of venous thromboembolism, major and minor bleeding, disease-free survival were compared.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 and ≤ 75 years;
  2. Primary tumour has undergone radical resection and histologically confirmed colorectal adenocarcinoma;
  3. without other organ metastasis or peritoneum metastasis
  4. without contradiction of cardiac and pulmonary diseases
  5. without prior venous thromboembolism and history of taking anticoagulant drugs
  6. without contraindications to heparin therapy
  7. Performance status (ECOG) 0~1
  8. Written informed consent for participation in the trial.
  9. Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization)
  10. Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either AST or ALT) ≤ 5 x ULN(within 1 week prior to randomization);

Exclusion Criteria:

  1. unresectable primary colorectal tumor or liver metastasis
  2. with other organ metastasis or peritoneum metastasis
  3. with contradiction of cardiac or pulmonary disease
  4. with prior venous thromboembolism or history of taking anticoagulant drugs
  5. with contraindications to heparin therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01972490

Contacts
Contact: jianmin Xu, MD 008613501984869 xujmin@aliyun.com

Locations
China, Shanghai
Zhongshan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200000
Contact: jianmin xu, MD    008613501984869    xujmin@aliyun.com   
Sponsors and Collaborators
Xu jianmin
  More Information

No publications provided

Responsible Party: Xu jianmin, Jianmin Xu, PhD Fudan University, Fudan University
ClinicalTrials.gov Identifier: NCT01972490     History of Changes
Other Study ID Numbers: LMWHCRM
Study First Received: September 23, 2013
Last Updated: October 29, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Fudan University:
colorectal neoplasms
low-molecular-weight heparin

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases
Calcium heparin
Dalteparin
Heparin
Heparin, Low-Molecular-Weight
Nadroparin
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014