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:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-25 @ 3:02 AM
NCT ID:
NCT00268333
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the colon or rectum
* Metastatic disease isolated to the following lymph nodes:
* Aortic
* Interaortic
* Celiomesenteric
* Retroperitoneal, including the following sites:
* Peri-uretal
* Liver
* Iliac
* Clavicle
* Mediastinum
* Inguinal
* Cervical
* Incompletely resected disease
* Recurrent disease, defined by 1 of the following criteria:
* Progression occurred within 6 months after prior oxaliplatin or after the patient received no prior oxaliplatin
* Progressive disease after cisplatin or fluorouracil
* Must be able to be encompassed in radiation field
PATIENT CHARACTERISTICS:
* ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
* Life expectancy more than 12 weeks
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000 /mm\^3
* Alkaline phosphatase ≤ 5 times normal
* Bilirubin ≤ 2 times normal
* Creatinine \< 2 times normal or creatinine clearance ≥ 40 mL/min
* No peripheral neuropathy \> grade 1
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No weight loss \> 15% since diagnosis of recurrent disease
* No uncontrolled heart disease
* No angina
* No symptomatic disease of the inferior artery
* No psychological, familial, sociological, or geographical condition that would preclude study treatment or compliance
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior chemotherapy or radiotherapy
* No concurrent corticosteroids
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00268333
Study Brief:
Protocol Section:
NCT00268333