Status:
TERMINATED
Prospective Randomised Phase II Trial Evaluating Adjuvant Pelvic Radiotherapy Using Either IMRT or 3-Dimensional Planning for Endometrial Cancer. ICORG 09-06
Lead Sponsor:
Cancer Trials Ireland
Conditions:
Endometrial Cancer
Gastrointestinal Complications
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Post-operative radiotherapy is internationally accepted as standard practice in the management of high-risk endometrial cancer1. Whilst it has no proven impact on overall survival it significantly inc...
Detailed Description
Primary Objective: • To compare the incidence of acute grade \>2 GU and GI toxicity Secondary Objectives: * To establish in the context of a clinical research study the feasibility of implementing ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2020
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT01164150
Start Date
March 1 2010
End Date
March 13 2020
Last Update
April 6 2023
Active Locations (5)
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1
St Luke's Radiation Oncology Network (SLRON) Centres
Dublin, Ireland, 6
2
St Luke's Centre for Radiation Oncology at Beaumont Hospital
Dublin, Ireland
3
St Luke's Centre for Radiation Oncology at St James Hospital
Dublin, Ireland
4
St Luke's Centre for Radiation Oncology at St Lukes Hospital
Dublin, Ireland