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 @ 11:00 PM
Ignite Modification Date:
2025-12-24 @ 11:00 PM
NCT ID:
NCT00178269
Eligibility Criteria:
Inclusion Criteria:
* Histologic confirmation of squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix including FIGO (International Federation of Gynecologists and Obstetricians) stage IB to IVA with or without pelvic adenopathy.
* No evidence of para-aortic or distant metastases. Must have evaluable disease.
* Zubrod Performance Status 0-2 or Karnofsky Performance Status \> 60
* Laboratory values must be as follows:
White blood cell count: \> 3,000/mm3,Absolute granulocyte count: \> 1,500/mm3, Hemoglobin \> 8.0 g/dl, Platelets: \> 100,000/mm3, Serum creatinine: \< 2.5 mg/dl, Serum calcium: \< 1.3 x institutional upper normal limit,Hepatic criteria as follows: Total Bilirubin \< ULN for the institution,
* Signed study-specific informed consent p
* Age \> 18 years.
* Peripheral neuropathy must be \< grade 1.
Exclusion Criteria:
* Prior or simultaneous malignancies (other than skin cancer) unless disease-free
* Medical illness preventing the use of taxane-based chemotherapy.
* Carcinoma of the cervix with the following histology: melanoma, sarcoma, small carcinoid, glassy cell, clear cell, and adenoid cystic.
* Previous or current medical or psychiatric illness that would prevent informed consent
* Patients known to be infected with HIV or a history of AIDS are excluded.
* Prior surgery for carcinoma of the cervix other than a biopsy.
* Patients with para-aortic disease.
* Previous pelvic radiation therapy or systemic chemotherapy is not permitted.
* Women who are pregnant or breast-feeding are excluded from this study.
* Previous history of hypersensitivity reaction to Taxotere or other drugs formulated with polysorbate 80 must be excluded.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00178269
Study Brief:
Protocol Section:
NCT00178269