Colorectal Cancer
Conditions
Brief summary
The optimum regimen of maintenance treatment after first-line chemotherapy in patients with metastatic colorectal cancer (mCRC) is unknown. This study was designed to determine the efficacy and safety of maintenance treatment with capecitabine metronomic chemotherapy versus conventional chemotherapy.
Detailed description
In this Prospective, open-label, randomised controlled trial, the investigators will recruit 250 mCRC patients who have finished 18 to 24 weeks first-line chemotherapy and disease evaluation is SD, PR or CR. Then, the patients will be randomised into two group. The experimental group, capecitabine metronomic chemotherapy versus capecitabine conventional chemotherapy as control group. These treatment regimens will be continued until progression, death, or an unacceptable adverse event. The primary endpoint is progression-free survival (PFS). Secondary endpoints are overall survival (OS), quality of life (QOL) and toxic effects.
Interventions
DRUGCapecitabine
we are going to compare two maintenance treatment models with capecitabine in this study
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histological proof of colorectal cancer (in case of a single metastasis, histological or cytological proof of this lesion should be obtained); * Distant metastases (patients with only local recurrence are not eligible); * Unidimensionally measurable disease (\> 1 cm on spiral CT scan or \> 2 cm on chest X-ray; liver ultrasound is not allowed). Serum CEA may not be used as a parameter for disease evaluation; * In case of previous radiotherapy, at least one measurable lesion should be located outside the irradiated field.
Exclusion criteria
* Prior adjuvant treatment for stage II/III colorectal cancer ending within 6 months before the start of induction treatment; * Any prior adjuvant treatment after resection of distant metastases; * Previous systemic treatment for advanced disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS1 | 4 months | from randomizing to progression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | 20 months | from signing informed consent form to death |
| QOL | 20 months | QLQ-C30 |
Countries
China
Contacts
Primary ContactHAO LI, MD，Ph.D
Backup ContactJUN ZHANG, MD，Ph.D
Outcome results
None listed