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 @ 3:22 AM
Ignite Modification Date:
2025-12-25 @ 3:22 AM
NCT ID:
NCT01397305
Eligibility Criteria:
Inclusion Criteria:
* Pathological/ cytological diagnosis of adenocarcinoma of the rectum. Patients must have operable rectal cancer that is amenable to surgery.
* No prior therapy for rectal cancer
* Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1
* Adequate organ function
* Patient compliance and geographic proximity that allow adequate follow-up
* For women: Must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after treatment; must have a negative serum or urine pregnancy test and must not be lactating.
* For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after treatment.
* Estimated life expectancy of at least 12 weeks
* Signed informed consent
* At least 18 years of age
Exclusion Criteria:
* Concurrent administration of any other anti-tumor therapy.
* Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
* Serious concomitant systemic disorders (e.g., active infection including HIV, cardiac disease) that in the opinion of the investigator would compromise the patient's ability to complete the study.
* Have previously completed or withdrawn from this study or any other study investigating pemetrexed.
* Are pregnant or breast-feeding.
* Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
* History of significant neurological or mental disorder, including seizures or dementia.
* Inability to interrupt aspirin or other nonsteroidal anto-inflammatory drugs (NSAIDs)
* Presence of clinically relevant third-space fluid collection that cannot be controlled by drainage or other procedures prior to study entry.
* Inability or unwillingness to be given 5,10-methylenetetrahydrofolate, vitamin B12 or dexamethasone.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01397305
Study Brief:
Protocol Section:
NCT01397305