Metastatic Colorectal Cancer
Conditions
Keywords
First line chemotherapy, FOLFOXIRI, standard doublet, Efficacy, Toxicity
Brief summary
This is a prospective randomized phase II trial was done in clinical oncology department at Kasr Alainy hospital, Cairo university (NEMROCK) to evaluate the role of intensification of chemotherapy in the first line for treatment of metastatic colorectal carcinoma by adding third agent to standard doublet regimen on oncological outcomes & assess tolerance to the intensified treatment
Detailed description
Patients with histologically proven adenocarcinoma of the colon or rectum, with unresectable measurable metastatic disease, were enrolled and randomized in a 1:1 ratio. Patients were assigned to receive FOLFOXIRI (experimental arm) or FOLFIRI or FOLFOX4 (control arm) biweekly up to 12 cycles. Randomization was done by enclosed envelope method Evaluation of the patients for surgical resection of residual metastases was done every 12 weeks. In the case of secondary resection of metastases, patients completed with the same chemotherapy regimen received before resection up to 12 cycles Maintenance therapy with capecitabine for 6 months was administered for patients who achieved complete or partial tumor response. In case of disease progression, second line chemotherapy was then administered in both groups until tumor progression, the occurrence of an unacceptable adverse event, or patient refusal
Interventions
Triplet chemotherapy regimen consists from active three cytotoxic agents aiming to improve outcomes
Sponsors
Kasr El Aini Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients with histologically proven adenocarcinoma of the colon or rectum, with unresectable measurable metastatic disease * No previous treatment for the metastatic disease was allowed, only previously fluoropyrimidine-based adjuvant chemotherapy was allowed if ended more than 6 months before enrollment in the study * Adequate haematological parameters (leukocyte count of at least 3,500/mm₃, neutrophil count of at least 1,500/ mm and platelet count of at least 100,000/mm * Adequate liver and renal function parameters (serum creatinine ≤ 1.3 mg/dL, serum bilirubin ≤ 1.5 mg/dL and AST, ALT and alkaline phosphatase 2.5 x upper normal values or less. * Patient had no co-morbidity disease
Exclusion criteria
* Poor performance status 3-4 according to ECOG score, prior chemotherapy for advanced, recurrent or metastatic disease, other simultaneous malignancies and pregnant or lactating female
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | 6 months ( from staring treatment till finishing 12 cycles, each cycle every 2 weeks) | the percentage of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria |
| Rate of adverse events | During the study treatment period till 30 days following the end of therapy | Adverse events (haematological & non-haematological) were assessed before each cycle using the Common Terminology Criteria for Adverse Events version (CTCAE) 5.0, 2017 with scale from (G0-5) for each event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | 18 months | the time from randomization to the first documentation of objective disease progression or death due to any cause, whichever occurs first. Documentation of disease progressive disease is defined as per RECIST 1.1 criteria based on investigator assessment |
| Overall survival time (OS) | 18 months | Defined as the length of time from date of randomization to the date of death due to any cause or due to lost follow up |
Countries
Egypt
Outcome results
None listed