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 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT00278304
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed carcinoma of the cervix of 1 of the following cellular subtypes:
* Squamous cell
* Adenocarcinoma
* Adenosquamous cell
* Stages IB-IVA disease
* Stage IVB disease allowed provided the impact on the quality of life is tremendous (e.g., "frozen pelvis" or massive pelvic disease and fistula formation, severe pain, or bleeding)
* Measurable and/or evaluable disease on MRI
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* No physical or physiological capacity that would preclude study treatment
* No cognitively impaired patients who cannot provide informed consent
* Not pregnant or nursing
* Negative pregnancy test
* No contraindication to MRI, including any of the following:
* Weight \> 136 kg
* Allergy to MR contrast agent
* Pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronic devices
* No significant unrelated systemic illness
* No serious infections
* No significant cardiac, pulmonary, hepatic, or other organ dysfunction that would preclude study treatment
* Must be medically fit to receive anesthesia
PRIOR CONCURRENT THERAPY:
* No prior definitive brachytherapy procedures
* Ring implants or intravaginal cones for the relief of excessive bleeding allowed
* No prior definitive surgical oncologic procedures (e.g., radical hysterectomy)
* Concurrent chemotherapy, immunotherapy, or hormonal therapy allowed
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00278304
Study Brief:
Protocol Section:
NCT00278304