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Trial record 20 of 1258 for:    Recruiting, Not yet recruiting, Available Studies | "Colorectal Neoplasms"

Phase II Study of Maintenance Capecitabine to Treat Resectable Colorectal Cancer (CAMCO)

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ClinicalTrials.gov Identifier: NCT01880658
Recruitment Status : Recruiting
First Posted : June 19, 2013
Last Update Posted : February 11, 2014
Sponsor:
Information provided by (Responsible Party):
Yanhong Deng, Sun Yat-sen University

Brief Summary:

RATIONALE: Surgical resection and adjuvant therapy has become the main treatment for resectable colorectal cancer. Treatment with current strategies, however,recurrent rate is high for stage IIIC or R0 resected stage IV. The efficacy and safety of maintenance therapy with capecitabine is still unknown.

PURPOSE: This single arm study is exploring surgical resection and adjuvant chemotherapy followed by maintenance therapy with capecitabine to see the efficacy and safety, then to investigate the effect of maintenance therapy for stage IIIC or R0 resected stage IV colorectal cancer.


Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Drug: Capecitabine Phase 2

Detailed Description:

OBJECTIVES Primary evaluate the disease free survival rate of three years in patients with stage IIIC or resectable stage IV colorectal cancer treated with maintenance capecitabine.

Secondary

  1. Evaluate the over all survival time in patients treated with these regimens.
  2. Correlate genetic patterns and the presence or absence of specific tissue biomarkers with response and prognosis in patients treated with these regimens.
  3. Determine quality of life (QOL) of patients treated with maintenance capecitabine versus chemotherapy termination.
  4. Determine the toxic effects of maintenance regimens in these patients.
  5. Determine the convenience of care in patients treated with maintenance regimens.

OUTLINE: This is a single arm, single-enter study. Patients are receiving therapies as below.

Patients undergo R0-R1 resection and receive adjuvant chemotherapy oxaliplatin with fluorouracil (5FU) and folinic acid(FOLFOX)or oxaliplatin with oxaliplatin with capecitabine(capox) for no less than 4 months. Radiotherapy may be applied for patients with rectal cancer if clinicians suspect that is necessary. Then patients receive oral capecitabine for 12 months maintenance.

Quality of life is assessed at completion of adjuvant treatment, at completion of maintenance chemotherapy , and at 1 year after maintenance chemotherapy.

After completion of adjuvant treatment, patients are followed every 3 months for 2 years, and then every 6 months for 3years.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.

Eligibility Ages Eligible for Study: 18-80 Years old Genders Eligible for Study: Both Accepts Healthy Volunteers: No


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial: Capecitabine Maintenance Therapy in Colorectal Cancer Patients With Stage IIIC and R0-R1 Resected Stage IV
Study Start Date : June 2013
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Capecitabine
Patients undergo R0-R1 resection and receive adjuvant chemotherapy FOLFOX or Capox for no less than 4 months. Radiotherapy may be applied for patients with rectal cancer if clinicians suspect that is necessary. Then patients receive oral capecitabine for 12 months maintenance.
Drug: Capecitabine
Capecitabine 1000mg/m2,po(orally) on day 1-14 of 21 day cycle. Number of cycles: 16 cycles (1 year)
Other Name: Xeloda




Primary Outcome Measures :
  1. Disease-free Survival rate(DFS) [ Time Frame: 36 months ]
    From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months


Secondary Outcome Measures :
  1. Over all survival,genetic patterns, quality of life, toxic effects, convenience [ Time Frame: 5 years ]
    1. Evaluate the over all survival time in patients treated with these regimens.
    2. Correlate genetic patterns and the presence or absence of specific tissue biomarkers with response and prognosis in patients treated with these regimens.
    3. Determine quality of life (QOL) of patients treated with maintenance capecitabine versus chemotherapy termination.
    4. Determine the toxic effects of maintenance regimens in these patients.
    5. Determine the convenience of care in patients treated with maintenance regimens.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of Adenocarcinoma of the colon or rectum
  2. Age:18-80 years old
  3. Received curative resection when diagnosed as colorectal cancer, postoperative stage: IIIC OR IV(R0 resected)
  4. Adjuvant chemotherapy with mFOLFOX6 or XELOX for more than four months 5.15 days prior recruit, meet the following criteria:

    • Hematopoietic
    • Absolute neutrophil count ≥ 1,500/mm^3
    • Platelet count ≥ 100,000/mm^3
    • Hepatic
    • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
    • Alkaline phosphatase ≤ 2 times ULN
    • Aspartate transaminase ≤ 2.5 times ULN
    • Alanine transaminase ≤ 2.5 times ULN
    • No hepatic disease that would preclude study treatment or follow-up
    • No uncontrolled coagulopathy
    • Renal
    • Creatinine clearance > 50 mL/min
    • No renal disease that would preclude study treatment or follow-up

6.The ECOG scores: 0~1

Exclusion Criteria:

  1. Other colorectal cancers (i.e.sarcoma,lymphoma,carcinoid,squamous cell carcinoma,or cloacogenic carcinoma)
  2. Synchronous cancer of other site
  3. Hypersensitivity to capecitabine
  4. No More than 4 weeks since prior participation in any investigational drug study
  5. Clear indication of involvement of the pelvic side walls by imaging With distant metastasis
  6. History of invasive rectal malignancy, regardless of disease-free interval Fertile patients must use effective contraception
  7. Uncontrolled hypertension
  8. Cardiovascular disease that would preclude study treatment or follow-up
  9. Lack of upper gastrointestinal tract integrity or malabsorption syndrome,active upper gastrointestinal tract bleeding
  10. Pregnant or nursing, Fertile patients do not use effective contraception
  11. Other malignancy within the past 5 years except effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum
  12. No psychiatric or addictive disorders, or other conditions that, in the opinion of the investigator, would preclude study participation

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): NCT01880658


Contacts
Contact: Yanhong Deng, MD 008613925106525 13925106525@163.com

Locations
China, Guangdong
Gastrointestinal Hospital, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510655
Contact: Yanhong Deng, MD    008613925106525    13925106525@163.com   
Principal Investigator: Yanhong Deng, MD         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Yanhong Deng, MD Sixth Affiliated Hospital, Sun Yat-sen University

Responsible Party: Yanhong Deng, associate professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01880658     History of Changes
Other Study ID Numbers: GIHSYSU03
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: February 11, 2014
Last Verified: July 2013

Keywords provided by Yanhong Deng, Sun Yat-sen University:
Maintenance therapy
Capecitabine
Adjuvant chemotherapy
Post-operation

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents