Phase II Study of Maintenance Capecitabine to Treat Resectable Colorectal Cancer

NCT ID: NCT01880658

Last Updated: 2014-02-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2019-05-31

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

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

Conditions

Colorectal Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Capecitabine

Intervention Type: DRUG

Capecitabine 1000mg/m2,po(orally) on day 1-14 of 21 day cycle. Number of cycles: 16 cycles (1 year)

Interventions

Capecitabine

Capecitabine 1000mg/m2,po(orally) on day 1-14 of 21 day cycle. Number of cycles: 16 cycles (1 year)

Intervention Type: DRUG

Other Intervention Names

Xeloda

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Yanhong Deng

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yanhong Deng, MD

Role: PRINCIPAL_INVESTIGATOR

Sixth Affiliated Hospital, Sun Yat-sen University

Locations

Gastrointestinal Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yanhong Deng, MD

Role: CONTACT

13925106525@163.com

008613925106525

Facility Contacts

Yanhong Deng, MD

Role: primary

13925106525@163.com

008613925106525

References

Ling J, Lin Z, Shi L, Lin Y, Liu X, Lin J, Li J, Zhang J, Hu H, Cai Y, Deng Y. Capecitabine maintenance therapy in metastatic colorectal cancer patients with no evidence of disease: CAMCO trial. Future Oncol. 2023 Sep;19(30):2045-2054. doi: 10.2217/fon-2023-0149. Epub 2023 Oct 10.

Reference Type: DERIVED

PMID: 37814832 (View on PubMed)

Other Identifiers

GIHSYSU03

Identifier Type: -

Identifier Source: org_study_id