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 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT00331760
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Must have undergone a hysterectomy (total abdominal, vaginal, radical, or laparoscopic-assisted vaginal) within 7 weeks prior to study entry
* Patients with endometrial cancer must have also undergone a bilateral salpingo-oophorectomy
* Histologically confirmed diagnosis of 1 of the following:
* Endometrial cancer meeting 1 of the following criteria:
* Stage IB grade 3, IC grade 1-3, IIA, or IIB disease requiring postoperative pelvic radiotherapy
* Unstaged (no lymph node dissection or sampling) stage IB grade 2 disease
* Stage IIIC with all of the following:
* Pelvic lymph node positive only
* Para-aortic nodes sampled negative
* Not receiving chemotherapy
* Cervical cancer meeting 1 of the following criteria:
* Post-radical hysterectomy and requires postoperative pelvic radiotherapy due to any of the following:
* Positive pelvic nodes (negative para-aortic nodes)
* Microscopic parametrial involvement and negative margins
* Disease qualified by Sedlis criteria must have 2 of the following risk factors:
* 1/3 or more stromal invasion
* Lymph-vascular space invasion
* Large clinical tumor diameter (≥ 4 cm)
* Post-simple hysterectomy with negative margins and negative nodes by CT scan, MRI, or positron emission tomography-CT scan
* No requirement for extended-field radiotherapy beyond the pelvis
* No histologically confirmed papillary serous, clear cell, or neuroendocrine (either large or small cell) disease, endometrial stromal sarcoma, leiomyosarcoma, or malignant müllerian mixed tumor
* No evidence of metastatic disease outside of the pelvis
* No microscopic involvement of the resection margin (\< 3 mm)
PATIENT CHARACTERISTICS:
* Zubrod performance status 0-2
* WBC (white blood cell count) ≥ 4,000/mm³ (cervical cancer patients only)
* Absolute neutrophil count ≥ 1,800/mm³ (cervical cancer patients only)
* Platelet count ≥ 100,000/mm³ (cervical cancer patients only)
* Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
* Serum creatinine ≤ 2.0 mg/dL (cervical cancer patients only)
* Creatinine clearance ≥ 50 mL/min (cervical cancer patients only)
* AST (aspartate aminotransferase) ≤ 2 times upper limit of normal
* Bilirubin ≤ 2 times upper limit of normal
* Patients must not exceed the weight and size limits of the treatment table or CT scanner
* No mental status changes or bladder control problems that would preclude study compliance with bladder-filling instructions
* No active inflammatory bowel disease
* No severe, active, concurrent illness, defined as any of the following:
* Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
* Transmural myocardial infarction within the past 6 months
* Acute bacterial or fungal infection requiring IV antibiotics
* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy
* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
* AIDS
* No history of allergy to cisplatin (cervical cancer patients)
* No prior invasive malignancy (except nonmelanoma skin cancer) unless disease-free for ≥ 3 years
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior radiotherapy to the pelvis that would result in overlap of radiotherapy fields
* No prior platinum-based chemotherapy (cervical cancer patients)
* No concurrent prophylactic growth factors (e.g., filgrastim \[G-CSF\], sargramostim \[GM-CSF\], or pegfilgrastim)
* No concurrent prophylactic thrombopoietic agents
* No concurrent amifostine or other protective agents
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00331760
Study Brief:
Protocol Section:
NCT00331760