Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT02086656
Eligibility Criteria:
Inclusion Criteria:
Inclusion criteria:
* Histological diagnosis of colorectal adenocarcinoma.
* Liver-limited metastases or metastases mainly (≥80% total disease burden) limited to the liver with extrahepatic disease judged resectable concomitantly or sequentially. Primary tumor may be resected or not, but patient must not be symptomatic for T.
* Previous adjuvant therapy is allowed if it had been terminated for at least 6 months.
* Previous first line treatment (irinotecan or oxaliplatin containing regimen) with stable or partial response after no more than 3 months of treatment
* Age \>= 18 years
* Performance Status (ECOG \<2)
* Adequate organ function including the following:
* Adequate bone marrow reserve: WBC count \>3.0x109/L, absolute neutrophil count \>1.5x109/L, platelet count \>100x109/L, and hemoglobin \>10 g/dL .
* Hepatic: bilirubin \< 1.5 times the ULN, alkaline phosphatase, aspartate transaminase, and alanine transaminase \< 2.5 xULN
* Renal : serum creatinin \<2.0xULN
* Patients compliance and geographic proximity that allows for adequate follow-up
* Patients must sign an informed consent document (ICD)
* Male and female patients with reproductive potential must use an approved contraceptive method.
Exclusion Criteria:
* Tumor involvement of liver \> 75%
* Chance of a liver remnant after surgery \< 25%
* Eligibility for concurrent radiotherapeutic treatment
* Disease progression during first line chemotherapy with FOLFOX, XELOX, FOLFIRI or XELIRI plus bevacizumab
* Previous treatment with more than 3 months of FOLFOX or FOLFIRI
* Previous therapy with bevacizumab or cetuximab or panitumumab
* Administration of other experimental drugs during the study.
* Body Mass Index \> 35
* Brain metastases.
* Pregnancy and breast-feeding.
* Serious or uncontrolled medical pathologies or active infections that would jeopardize the possibility of receiving the investigated treatment. Disorders that could influence the absorption of capecitabine (e.g. malabsorption), intestinal occlusion, Crohn's disease or ulcerative colitis.
* Psychiatric disorders, neurologic disease or other conditions that would make it impossible to comply with the protocol procedures. Peripheral neuropathy not related to oxaliplatin previous administration.
* Previous dangerous life threatening toxicities from fluoropyrimidine.
* Positive anamnesis with regard to other neoplastic diseases except for the ones that have been cured for more than 5 years.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02086656
Study Brief:
Protocol Section:
NCT02086656