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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

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Maintenance therapy, Capecitabine, Adjuvant chemotherapy, Post-operation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT01880658

First Posted

June 5, 2013

Last Updated

February 8, 2014

Sponsor

Sun Yat-sen University

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

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

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

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

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

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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