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

February 8, 2014 updated by: Yanhong Deng, Sun Yat-sen University

Phase II Clinical Trial: Capecitabine Maintenance Therapy in Colorectal Cancer Patients With Stage IIIC and R0-R1 Resected Stage IV

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • Recruiting
        • Gastrointestinal Hospital, Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Xeloda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Yanhong Deng, MD, Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ANTICIPATED)

May 1, 2016

Study Completion (ANTICIPATED)

May 1, 2019

Study Registration Dates

First Submitted

June 5, 2013

First Submitted That Met QC Criteria

June 15, 2013

First Posted (ESTIMATE)

June 19, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 11, 2014

Last Update Submitted That Met QC Criteria

February 8, 2014

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIHSYSU03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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