Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-03-13 @ 9:32 PM
Study NCT ID:
NCT01880658
Status:
UNKNOWN
Last Update Posted:
2014-02-11
First Post:
2013-06-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Study of Maintenance Capecitabine to Treat Resectable Colorectal Cancer
Sponsor:
Sun Yat-sen University
Organization:
Study Overview
Official Title:
Phase II Clinical Trial: Capecitabine Maintenance Therapy in Colorectal Cancer Patients With Stage IIIC and R0-R1 Resected Stage IV
Status:
UNKNOWN
Status Verified Date:
2013-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAMCO
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.
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
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: