Phase II Study of Maintenance Capecitabine to Treat Resectable Colorectal Cancer (CAMCO)
Primary Purpose
Colorectal Neoplasms
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Maintenance therapy, Capecitabine, Adjuvant chemotherapy, Post-operation
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Adenocarcinoma of the colon or rectum
- Age:18-80 years old
- Received curative resection when diagnosed as colorectal cancer, postoperative stage: IIIC OR IV(R0 resected)
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:
- Other colorectal cancers (i.e.sarcoma,lymphoma,carcinoid,squamous cell carcinoma,or cloacogenic carcinoma)
- Synchronous cancer of other site
- Hypersensitivity to capecitabine
- No More than 4 weeks since prior participation in any investigational drug study
- Clear indication of involvement of the pelvic side walls by imaging With distant metastasis
- History of invasive rectal malignancy, regardless of disease-free interval Fertile patients must use effective contraception
- Uncontrolled hypertension
- Cardiovascular disease that would preclude study treatment or follow-up
- Lack of upper gastrointestinal tract integrity or malabsorption syndrome,active upper gastrointestinal tract bleeding
- Pregnant or nursing, Fertile patients do not use effective contraception
- 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
- No psychiatric or addictive disorders, or other conditions that, in the opinion of the investigator, would preclude study participation
Sites / Locations
- Gastrointestinal Hospital, Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Capecitabine
Arm Description
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.
Outcomes
Primary Outcome Measures
Disease-free Survival rate(DFS)
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
Over all survival,genetic patterns, quality of life, toxic effects, convenience
Evaluate the over all survival time in patients treated with these regimens.
Correlate genetic patterns and the presence or absence of specific tissue biomarkers with response and prognosis in patients treated with these regimens.
Determine quality of life (QOL) of patients treated with maintenance capecitabine versus chemotherapy termination.
Determine the toxic effects of maintenance regimens in these patients.
Determine the convenience of care in patients treated with maintenance regimens.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01880658
Brief Title
Phase II Study of Maintenance Capecitabine to Treat Resectable Colorectal Cancer
Acronym
CAMCO
Official Title
Phase II Clinical Trial: Capecitabine Maintenance Therapy in Colorectal Cancer Patients With Stage IIIC and R0-R1 Resected Stage IV
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
May 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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
Evaluate the over all survival time in patients treated with these regimens.
Correlate genetic patterns and the presence or absence of specific tissue biomarkers with response and prognosis in patients treated with these regimens.
Determine quality of life (QOL) of patients treated with maintenance capecitabine versus chemotherapy termination.
Determine the toxic effects of maintenance regimens in these patients.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
Maintenance therapy, Capecitabine, Adjuvant chemotherapy, Post-operation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Capecitabine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
Capecitabine 1000mg/m2,po(orally) on day 1-14 of 21 day cycle. Number of cycles: 16 cycles (1 year)
Primary Outcome Measure Information:
Title
Disease-free Survival rate(DFS)
Description
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
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Over all survival,genetic patterns, quality of life, toxic effects, convenience
Description
Evaluate the over all survival time in patients treated with these regimens.
Correlate genetic patterns and the presence or absence of specific tissue biomarkers with response and prognosis in patients treated with these regimens.
Determine quality of life (QOL) of patients treated with maintenance capecitabine versus chemotherapy termination.
Determine the toxic effects of maintenance regimens in these patients.
Determine the convenience of care in patients treated with maintenance regimens.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Adenocarcinoma of the colon or rectum
Age:18-80 years old
Received curative resection when diagnosed as colorectal cancer, postoperative stage: IIIC OR IV(R0 resected)
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:
Other colorectal cancers (i.e.sarcoma,lymphoma,carcinoid,squamous cell carcinoma,or cloacogenic carcinoma)
Synchronous cancer of other site
Hypersensitivity to capecitabine
No More than 4 weeks since prior participation in any investigational drug study
Clear indication of involvement of the pelvic side walls by imaging With distant metastasis
History of invasive rectal malignancy, regardless of disease-free interval Fertile patients must use effective contraception
Uncontrolled hypertension
Cardiovascular disease that would preclude study treatment or follow-up
Lack of upper gastrointestinal tract integrity or malabsorption syndrome,active upper gastrointestinal tract bleeding
Pregnant or nursing, Fertile patients do not use effective contraception
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
No psychiatric or addictive disorders, or other conditions that, in the opinion of the investigator, would preclude study participation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanhong Deng, MD
Phone
008613925106525
Email
13925106525@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanhong Deng, MD
Organizational Affiliation
Sixth Affiliated Hospital, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gastrointestinal Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanhong Deng, MD
Phone
008613925106525
Email
13925106525@163.com
First Name & Middle Initial & Last Name & Degree
Yanhong Deng, MD
12. IPD Sharing Statement
Learn more about this trial
Phase II Study of Maintenance Capecitabine to Treat Resectable Colorectal Cancer
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