Endometrial CancerPhase 2NCT01164150
Prospective Randomised Phase II Trial Evaluating Adjuvant Pelvic Radiotherapy Using Either IMRT or 3-Dimensional Planning for Endometrial Cancer. ICORG 09-06
A Phase 2 study testing 45 Gy/25 fractions in people with Endometrial Cancer and Gastrointestinal Complications, run by Cancer Trials Ireland at 5 sites in Ireland.
Trial 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 increases local control. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Gastrointestinal Complications, Radiation Toxicity
- What is being tested?
- 45 Gy/25 fractions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 5 sitesIreland
- Study dates
- Mar 2010to 13 Mar 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- ECOG PS 0-2
- Age ≥ 18 years
- Provision of written informed consent in line with ICH-GCP guidelines
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Ireland5 sites
St Luke's Radiation Oncology Network (SLRON) Centres
Dublin, 6
St Luke's Centre for Radiation Oncology at Beaumont Hospital
Dublin
St Luke's Centre for Radiation Oncology at St James Hospital
Dublin
St Luke's Centre for Radiation Oncology at St Lukes Hospital
Dublin
Mid-Western Radiation Oncology Centre
Limerick
About this study
Official title: Prospective Randomised Phase II Trial Evaluating Adjuvant Pelvic Radiotherapy Using Either IMRT or 3-Dimensional Planning for Endometrial Cancer
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 increases local control.
Conventional radiotherapy techniques (3-dimensional) utilise a 3 or 4 field beam arrangement to target the pelvis in order to treat those areas at risk of recurrence: the vagina, the parametrium and the pelvic lymph nodes. However, when using such a technique it is not possible to avoid irradiating sensitive normal tissues such as the bowel and bladder.
Read more
Toxicity data from international randomised control trials in endometrial cancer report significantly more haematological, gastrointestinal, genitourinary and cutaneous toxicites (all grades) in those who received pelvic irradiation compared to those who did not2,3. These trials delivered radiotherapy using 2 or 3-dimensional techniques.
Intensity Modulated Radiation Therapy (IMRT) is a newer but established radiotherapy technique in many tumour sites that allows us to much more tightly conform the radiation. It uses computer-generated beams to produce radiotherapy volumes that can avoid irradiation of normal tissues in the pelvis.
There are no randomised studies reported in the literature that compare 3-dimensional pelvic irradiation with IMRT in patients who have had surgery for endometrial cancer. However there are several small studies that report considerable sparing of normal tissues using IMRT and when compared retrospectively with conventionally treated patients demonstrate marked reductions in acute gastrointestinal and genitourinary toxicity4.
By delivering post-operative radiotherapy to the pelvis using IMRT (as opposed to the standard 3-dimensional technique) it is anticipated that whilst local control and survival will be unaffected acute and late toxicity will be reduced.
Read the 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 pelvic nodal irradiation using IMRT in gynaecological cancer
- To establish an Image-Guided pathway for gynaecological cancer radiotherapy incorporating
- Set-up errors and optimal margins for set-up uncertainty
- Investigation of effects of bladder filling and rectal preparation protocols on the planning target volume
- To estimate the rate of loco-regional control
- To evaluate Quality of Life
- To estimate the rate of disease-free survival
- To estimate the overall survival rate
- To compare the incidence of late GU and GI toxicity
- Conditions
- Endometrial Cancer, Gastrointestinal Complications, Radiation Toxicity, Urinary Complications
- Being tested
- 45 Gy/25 fractions
- Keywords
- gastrointestinal complications, urinary complications, radiation toxicity, recurrent endometrial carcinoma, endometrial adenocarcinoma, stage IA endometrial carcinoma, stage IB endometrial carcinoma, stage II endometrial carcinoma, stage IIIA endometrial carcinoma, stage IIIB endometrial carcinoma, stage IIIC endometrial carcinoma
- Medical subject headings
- Endometrial Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
45 Gy/25 fractionsRadiation
Arm A 45 Gy/25 fractions pelvic radiotherapy using 3D planned technique followed by 11Gy/2 fractions vaginal vault brachytherapy
| Study group | Role | What they receive |
|---|---|---|
| Arm B | Experimental | Radiation: 45 Gy / 25 fractions pelvic radiotherapy using intensity modulated radiotherapy (IMRT) followed by 11 Gy / 2 fractions vaginal vault brachytherapy Receives: Radiation: 45 Gy/25 fractions |
| Arm A Control | Other | Radiation: 45 Gy/25 fraction external beam pelvic radiotherapy delivered using a 3-dimensional planned technique followed by 11 Gy / 2 fractions vaginal vault brachytherapy Receives: Radiation: 45 Gy/25 fractions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the incidence of ≥ grade 2 acute genitourinary (GU) and gastrointestinal (GI) toxicity according to NCI CTCAE v.3.0
Measured: 2015
Secondary outcomes (7)
Incidence of late GI and GU toxicity according to NCI CTCAE v.3.0
Measured: 2015
Feasibility of implementing pelvic nodal irradiation using intensity-modulated radiotherapy in gynecological cancer
Measured: 2015
Establishment of an image-guided pathway for gynecological cancer radiotherapy
Measured: 2015
Rate of loco-regional control as assessed by CT scan, MRI, and biopsy
Measured: 2015
Quality of life as assessed using EORTC QLQ-C30 and EORTC QLQ Cervical Cancer Specific Module CX 24 questionnaires
Measured: 2015
Rate of disease-free survival
Measured: 2015
Overall survival rate
Measured: 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study startMar 2010
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Charles Gillham, Dr, Principal investigator, Saint Luke's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01164150
- Sponsor's protocol ID
- CTRIAL-IE (ICORG) 09-06
- Other IDs
- CTRIAL-IE (ICORG) 09-06, EU-21048
- Status last verified
- Apr 2026
- First submitted
- 15 Jul 2010
- Last updated
- 13 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Phase II Trial Evaluating Adjuvant Pelvic Radiotherapy Using Either IMRT or 3-Dimensional Planning for Endometrial Cancer
- ClinicalTrials.gov ID
- NCT01164150
- Acronym / sponsor ID
- CTRIAL-IE (ICORG) 09-06
- Conditions
- Endometrial Cancer, Gastrointestinal Complications, Radiation Toxicity, Urinary Complications
- Keywords
- gastrointestinal complications, urinary complications, radiation toxicity, recurrent endometrial carcinoma, endometrial adenocarcinoma, stage IA endometrial carcinoma, stage IB endometrial carcinoma, stage II endometrial carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- Mar 2010 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 16 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 increases local control.
Conventional radiotherapy techniques (3-dimensional) utilise a 3 or 4 field beam arrangement to target the pelvis in order to treat those areas at risk of recurrence: the vagina, the parametrium and the pelvic lymph nodes. However, when using such a technique it is not possible to avoid irradiating sensitive normal tissues such as the bowel and bladder.
Toxicity data from international randomised control trials in endometrial cancer report significantly more haematological, gastrointestinal, genitourinary and cutaneous toxicites (all grades) in those who received pelvic irradiation compared to those who did not2,3. These trials delivered radiotherapy using 2 or 3-dimensional techniques.
Intensity Modulated Radiation Therapy (IMRT) is a newer but established radiotherapy technique in many tumour sites that allows us to much more tightly conform the radiation. It uses computer-generated beams to produce radiotherapy volumes that can avoid irradiation of normal tissues in the pelvis.
There are no randomised studies reported in the literature that compare 3-dimensional pelvic irradiation with IMRT in patients who have had surgery for endometrial cancer. However there are several small studies that report considerable sparing of normal tissues using IMRT and when compared retrospectively with conventionally treated patients demonstrate marked reductions in acute gastrointestinal and genitourinary toxicity4.
By delivering post-operative radiotherapy to the pelvis using IMRT (as opposed to the standard 3-dimensional technique) it is anticipated that whilst local control and survival will be unaffected acute and late toxicity will be reduced.
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 pelvic nodal irradiation using IMRT in gynaecological cancer
- To establish an Image-Guided pathway for gynaecological cancer radiotherapy incorporating
- Set-up errors and optimal margins for set-up uncertainty
- Investigation of effects of bladder filling and rectal preparation protocols on the planning target volume
- To estimate the rate of loco-regional control
- To evaluate Quality of Life
- To estimate the rate of disease-free survival
- To estimate the overall survival rate
- To compare the incidence of late GU and GI toxicity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm B | Experimental | Radiation: 45 Gy/25 fractionsRadiation: 45 Gy / 25 fractions pelvic radiotherapy using intensity modulated radiotherapy (IMRT) followed by 11 Gy / 2 fractions vaginal vault brachytherapy |
| Arm A Control | Other | Radiation: 45 Gy/25 fractionsRadiation: 45 Gy/25 fraction external beam pelvic radiotherapy delivered using a 3-dimensional planned technique followed by 11 Gy / 2 fractions vaginal vault brachytherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 45 Gy/25 fractionsArm A 45 Gy/25 fractions pelvic radiotherapy using 3D planned technique followed by 11Gy/2 fractions vaginal vault brachytherapy | Radiation | Arm A Control, Arm B |
Primary outcome
Reduction in the incidence of ≥ grade 2 acute genitourinary (GU) and gastrointestinal (GI) toxicity according to NCI CTCAE v.3.0
Time frame: 2015
7 secondary outcomes
Incidence of late GI and GU toxicity according to NCI CTCAE v.3.0
Time frame: 2015
Feasibility of implementing pelvic nodal irradiation using intensity-modulated radiotherapy in gynecological cancer
Time frame: 2015
Establishment of an image-guided pathway for gynecological cancer radiotherapy
Time frame: 2015
Rate of loco-regional control as assessed by CT scan, MRI, and biopsy
Time frame: 2015
Quality of life as assessed using EORTC QLQ-C30 and EORTC QLQ Cervical Cancer Specific Module CX 24 questionnaires
Time frame: 2015
Rate of disease-free survival
Time frame: 2015
Overall survival rate
Time frame: 2015
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Gillham, Dr principal investigator
Saint Luke's Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 45 Gy/25 fractions in people with Endometrial Cancer and Gastrointestinal Complications, run by Cancer Trials Ireland at 5 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the incidence of ≥ grade 2 acute genitourinary (GU) and gastrointestinal (GI) toxicity according to NCI CTCAE v.3.0 (time frame: 2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.