Metastatic Colorectal Cancer
Conditions
Brief summary
Colorectal cancer patients with metastases (mCRC) at response under first-line chemotherapy are candidates for an convenient maintenance treatment.
Detailed description
Colorectal cancer is one of the most common malignant tumors, with the morbidity of approximate 100 million cases per year. About 40% of patients present with metastatic (stage IV) colorectal cancer at the time of diagnosis, and about 25% of patients with local lesion will ultimately develop metastatic disease.Therefore, our study is designed to investigate that colorectal cancer patients with metastases (mCRC) at response under first-line chemotherapy are candidates for an convenient maintenance treatment.
Interventions
DRUGCapecitabine
14days
OTHERplacebo
14 days
Sponsors
Beijing Chao Yang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
\- Age between 18 and 75 years Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 histologically confirmed colorectal cancer with inoperable locally advanced or recurrent and/or metastatic disease Life expectancy of at least 3 months Intact organ function, including complete blood counts (CBC) showing normal values or any toxicity limited to grade 1 and blood chemistry (SMA) showing liver and renal functions \< 1.5 upper normal limit (UNL). Patients who achieved objective response or stable disease after 16-24 weeks first line chemotherapy Signed informed consent
Exclusion criteria
\- Known hypersensitivity to capecitabine Concurrent any other cancer (except BCC or squamous cell carcinoma of skin). Inability to adhere to monthly visits to the oncology unit for evaluation. Presence of brain metastases. Previous radiotherapy to the only site of measurable disease. Evidence of severe or uncontrolled systemic disease No previous chemotherapy for metastatic disease Positive serum pregnancy test in women of childbearing potential unresolved bowel obstruction or malabsorption syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DDC:Duration of Disease Control | 2 years | progression-free survival of first-line chemotherapy with second-line chemotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS:Overall Survival | 2 years | measured from the initiation of chemotherapy to the date of the last follow-up or death |
| DCR:Disease Control Rate | 2 years | This is defined as the occurrence of either a confirmed complete (CR),a partial response(PR)or stable disease(SD) as determined by the RECIST criteria from confirmed radiographic evaluations of target and non-target lesions. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety | 2 years | Adverse events and laboratory tests graded according to the NCI-CTC AE Version 4. |
Contacts
Primary ContactDong Yan, PhD
Outcome results
None listed