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 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT01101451
Eligibility Criteria:
Inclusion Criteria:
* Pathologically proven primary cervical cancer I-IIA with squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma initially treated with a standard radical hysterectomy with pelvic lymphadenectomy
* Patients with the following characteristics (depth of stromal invasion and lymphovascular space involvement to be pathologically confirmed):
* Positive capillary-lymphovascular space involvement and one of the following:
* Deep third penetration
* Middle third penetration, clinical tumor \>= 2 cm
* Superficial third penetration, clinical tumor \>= 5 cm
* Negative capillary-lymphatic space involvement
* Middle or deep third penetration, clinical tumor \>= 4 cm
* Absolute neutrophil count (ANC) \>= 1,500/mcl
* Platelets \>= 100,000/mcl
* Creatinine =\< upper limit of normal (ULN) or calculated creatinine clearance \>= 60 mL/min
* Bilirubin =\< 1.5 x normal
* Alkaline phosphate =\< 3 x normal
* Serum glutamic oxaloacetic transaminase (SGOT) =\< 3 x normal
* Gynecologic Oncology Group (GOG) performance status 0, 1, 2
* Patients should not be randomized less than 3 weeks post-surgery but will not be acceptable for randomization more than 8 weeks post-surgery
* Patients who have met the pre-entry requirements
* Patients must have signed an approved informed consent and authorization permitting release of personal health information
Exclusion Criteria:
* Patients with tumor in the parametria, pelvic lymph nodes or any other extra uterine site or with positive surgical margins
* Patients with septicemia or severe infection
* Patients with intestinal obstruction or gastrointestinal bleeding
* Patients with postoperative fistula
* Patients with cervix cancer who have received any previous radiation or chemotherapy
* Patients whose circumstances do not permit completion of the study or the required follow-up
* Patients with renal abnormalities requiring modification of radiation field (pelvic kidney, renal transplant, etc.)
* Patients with GOG performance status of 3 or 4
* Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01101451
Study Brief:
Protocol Section:
NCT01101451