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:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT00541112
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the rectum
* Locally advanced (T3-4 Nx) or metastatic (T2 N+ M1) synchronous disease
* Metastases must be resectable
* Primary tumor examined by endorectal echography and MRI
* Measurable disease by thoraco-abdomino-pelvic scanner
* Disease considered susceptible to treatment with radiotherapy and chemotherapy
* No diffuse metastases considered nonresectable
* No acute occlusion not caused by colostomy
PATIENT CHARACTERISTICS:
Inclusion criteria:
* ECOG performance status 0-2
* WBC ≥ 4,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 10 g/dL
* Creatinine ≤ 130 µmol/L
* Transaminases ≤ 5 times upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients of must use effective contraception
Exclusion criteria:
* Contraindication to therapy with capecitabine, oxaliplatin, cetuximab, and/or radiotherapy
* Impossible to perform translational analyses
* Uncontrolled severe illness
* Severe renal or hepatic insufficiency
* Cardiac insufficiency or symptomatic coronary disease
* Sensitive peripheral neuropathy
* Uncontrolled diabetes
* Other malignancy within the past 10 years except previously treated basal cell skin cancer or carcinoma in situ of the cervix
* Impossible to participate in study due to geographic, social, or psychiatric reasons
* Patients who are under supervision or incarcerated
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior anticancer chemotherapy or radiotherapy for this cancer
* No therapy with coumarin anticoagulants, phenytoin, sorivudine, brivudine, antacids, or allopurinol
* No concurrent participation in another therapeutic study or receiving another experimental drug
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00541112
Study Brief:
Protocol Section:
NCT00541112