Study of Metronomic Capecitabine and Oxaliplatin Versus XELOX in Egyptian Metastatic Colorectal Cancer Patients

NCT ID: NCT04425564

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2019-12-31

Brief Summary

Colorectal cancer (CRC) in Egypt is advanced tumors at diagnosis. Although, the dramatic increase in efficacy, reduction of mortality, and improvements in survival by the use of standard doses of chemotherapy, some CRC patients suffer from severe toxicities besides disease progression. Use of chemotherapy less than the maximum tolerated dose, with no prolonged drug free breaks incapacitates the cells to engage in progression mechanisms, suggesting that it could be a better alternative to standard dose therapy with better toxicity profile

Detailed Description

This is a randomized phase II prospective study that included 70 (35 in each arm) metastatic Egyptian CRC cancer patients diagnosed at the National Cancer Institute, Cairo University between January 2016 and June 2018). Patients were randomly treated with either classic XELOX (arm A) or with capecitabine (2000 mg daily x 8 weeks) and oxaliplatin (30 mg/m2 weekly X 8 weeks) then 2 weeks rest (arm B). Toxicities and the survival analysis after two years for both regimens were recorded. Blood samples are taken from both groups to assess pharmacokinetics of capecitabine and its relation to dosing.

Conditions

Clinical Response; Toxicity; Survival

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Classic (A)

patients recieving classic XELOX (oxaliplatin 130mg/m2 and capecitabine 1000mg/m2 bid)

Group Type: ACTIVE_COMPARATOR

Classic XELOX

Intervention Type: DRUG

Blood samples for pharmacological studies

Intervention Type: OTHER

metronomic (B)

patients recieving low dose capecitabine (2000mg daily divided in two doses for 8 weeks) and oxaliplatin (30mg/m2 weekly for eight weeks) followed by 2 weeks rest.

Group Type: EXPERIMENTAL

metronomic XELOX

Intervention Type: DRUG

Blood samples for pharmacological studies

Intervention Type: OTHER

Interventions

metronomic XELOX

Intervention Type: DRUG

Classic XELOX

Intervention Type: DRUG

Blood samples for pharmacological studies

Intervention Type: OTHER

Other Intervention Names

Capecitabine; Oxaliplatin; Capecitabine; Oxaliplatin; No other names

Eligibility Criteria

Inclusion Criteria

• Patient age 18-70 years of both sexes.
• PS 0-2 and histologically proven mCRC with unresectable metastases (rectal cancer is included to left side cancers).
• They should have measurable lesions (that can be accurately measured in at least one dimension using calipers or ruler and measurement must be at least 20 mm using conventional techniques or 10 mm using spiral CT scan).
• No previous treatment for metastatic disease and had ended adjuvant treatment > 6 months.
• peripheral neuritis less than grade 2.
• Normal organ functions:(Creatinine ≤1.2, Bilirubin ≤1.2, SGOT/SGPT< 2N, HB >9gm/dl, WBC>3.5/dl with ANC >1.5/dl, Plat ≥100/dl).
• For patients with liver metastases, Bilirubin should not be >2.5N and transaminases not >5N. (All patients were screened for HCV and HBS Ag by PCR).
• Adequate cardiac functions (EF>55%)

Exclusion Criteria

• patients with only ascites or bone metastasis

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

201516007.3

Identifier Type: -

Identifier Source: org_study_id