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

Phase 2
18 Years
80 Years
Open (Enrolling)
Colorectal Neoplasms

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Trial Information

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

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.


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

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

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

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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free Survival rate(DFS)

Outcome 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

Outcome Time Frame:

36 months

Safety Issue:


Principal Investigator

Yanhong Deng, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The sixth affiliated hospital of Sun Yat-sen University


China: Food and Drug Administration

Study ID:




Start Date:

June 2013

Completion Date:

May 2019

Related Keywords:

  • Colorectal Neoplasms
  • Maintenance therapy
  • Capecitabine
  • Adjuvant chemotherapy
  • Post-operation
  • Neoplasms
  • Colorectal Neoplasms