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 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
NCT ID:
NCT01164150
Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing adjuvant pelvic radiotherapy for histologically confirmed endometrial adenocarcinoma / serous carcinoma / papillary serous carcinoma / mixed histology (adenocarcinoma and serous) and following AJCC 2009 grade/stage:
* Grade 2: stage IB (LVSI +/or \>60yrs)
* Grade 3: stage IA and IB
* Grade 1-3: Stage II and IIIA, IIIB and IIIC1
* Surgery consisting of total hysterectomy, +/- bilateral salpingo-oophorectomy, +/- lymph node sampling
* Staging with imaging of pelvis and abdomen (either MRI or CT)
* ECOG PS 0-2
* Age ≥ 18 years
* Provision of written informed consent in line with ICH-GCP guidelines
Exclusion Criteria:
* Previous radiotherapy to the pelvic region
* Patients in whom concurrent chemotherapy in planned
* Patients with macroscopic disease in situ
* History of inflammatory bowel disease
* Previous hip replacement
* Previous bowel surgery (excluding appendectomy)
* Patients with other syndromes/conditions associated with increased radiosensitivity
* The patient has or had other co-existing malignancies within the past 5 years other than non-melanoma skin cancer
* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study or if it is felt by the research / medical team that the patient may not be able to comply with the protocol
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01164150
Study Brief:
Protocol Section:
NCT01164150