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Trial record 54 of 297 for:    colon cancer AND Capecitabine AND chemotherapy

A Phase Ⅱ Study of XELOX Chemotherapy With or Without Surgery of Primary Lesion for Colon Cancer Patients

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ClinicalTrials.gov Identifier: NCT02291744
Recruitment Status : Unknown
Verified November 2015 by Weijian Guo, Fudan University.
Recruitment status was:  Recruiting
First Posted : November 14, 2014
Last Update Posted : November 11, 2015
Sponsor:
Information provided by (Responsible Party):
Weijian Guo, Fudan University

Brief Summary:
The primary endpoint is to evaluate the TFS (time to failure of strategy).

Condition or disease Intervention/treatment Phase
Metastatic Colon Cancer Procedure: resection of primary lesion Drug: XELOX Phase 2

Detailed Description:
The primary endpoint is to evaluate the time to failure of strategy, that is the second progression time after induction therapy by the use of XELOX regimen, comparing XELOX regimen chemotherapy combined with or without surgical resection of the primary lesion from the time of randomization to maintenance therapy and reapplication of induction therapy, or time to the use of second line strategy (if no reapplication of induction therapy) or time to no further treatment.

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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 Randomized Phase Ⅱ Study of XELOX Chemotherapy With or Without Surgery of Primary Lesion for Colon Cancer Patients With Unresectable Metastatic Lesions
Study Start Date : October 2014
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Arm Intervention/treatment
Experimental: XELOX plus surgery
Eight cycles of XELOX chemotherapy plus surgery:Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle. After 4 cycles, the patients are randomized to surgery group. Then the rest four cycles are administrated.
Procedure: resection of primary lesion
Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle, and resection of primary lesion with metastatic colon cancer

Drug: XELOX
Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle,

Active Comparator: XELOX
Eight cycles of XELOX chemotherapy: Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle
Drug: XELOX
Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle,




Primary Outcome Measures :
  1. TFS time of failure of strategy (the second progression time after induction therapy, or time to the use of second line strategy (if no reapplication of induction therapy) or time to no further treatment) [ Time Frame: the second progression time after induction therapy, or time to the use of second line strategy (if no reapplication of induction therapy) or time to no further treatment. The average time is three years. ]


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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:

  1. 18~75 ears old
  2. Pathological diagnosis of colon cancer adenocarcinoma
  3. No systemic chemotherapy for metastatic tumors
  4. ECOG (Eastern Cooperative Oncology Group) 0-1 and expected survival period for 6 months or more
  5. At least one measurable objective tumor lesions
  6. ANC≥1.5*109/L;PLT≥90*109/L;HB≥90g/L;TBI≤1.5(UNL); ALT、AST≤2.5ULN;Cr≤1.0(ULN) screening within 7 days
  7. Primary and metastatic tumors exist at the same time, and distant metastases are not resectable
  8. Patients with voluntary participation, and sign the informed consent

Exclusion Criteria:

  1. Operation intervention required for perforation, bleeding and obstruction of intestinal cavity
  2. With uncontrollable large pleural or peritoneal effusion
  3. Alcohol or drug addictions
  4. Malignant tumour of the past five years with other organizations to source, but the full treatment of cervical carcinoma in situ and except skin basal cell carcinoma and squamous cell carcinomas
  5. With brain metastasis
  6. Multiple primary colorectal carcinoma
  7. Pregnancy or breast-feeding women
  8. There is an important organ failure or other serious diseases, including coronary artery disease, symptomatic cardiovascular disease or myocardial infarction within 12 months; serious neurological or psychiatric history; severe infection; actively disseminated vascula blood coagulation.

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): NCT02291744


Contacts
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Contact: Weijian Guo, doctor 13816066360 mingzhuhuang0718@163.com

Locations
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China, Shanghai
Fudan University Cancer Hospital Recruiting
ShangHai, Shanghai, China, 200032
Contact: Wei Jian Guo, PHD         
Sponsors and Collaborators
Fudan University

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Responsible Party: Weijian Guo, professor, Fudan University
ClinicalTrials.gov Identifier: NCT02291744     History of Changes
Other Study ID Numbers: guoweijian-2014-XELOX
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: November 11, 2015
Last Verified: November 2015
Keywords provided by Weijian Guo, Fudan University:
TFS (time to failure of strategy)
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Capecitabine
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents