Prospective Randomised Phase II Trial Evaluating Adjuvant Pelvic Radiotherapy Using Either IMRT or 3-Dimensional Planning for Endometrial Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer Gastrointestinal Complications Radiation Toxicity Urinary Complications |
Radiation: 45 Gy/25 fractions |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Prospective Randomised Phase II Trial Evaluating Adjuvant Pelvic Radiotherapy Using Either IMRT or 3-Dimensional Planning for Endometrial Cancer |
- Reduction in the incidence of ≥ grade 2 acute genitourinary (GU) and gastrointestinal (GI) toxicity according to NCI CTCAE v.3.0 [ Time Frame: 2015 ] [ Designated as safety issue: Yes ]
- Incidence of late GI and GU toxicity according to NCI CTCAE v.3.0 [ Time Frame: 2015 ] [ Designated as safety issue: Yes ]
- Feasibility of implementing pelvic nodal irradiation using intensity-modulated radiotherapy in gynecological cancer [ Time Frame: 2015 ] [ Designated as safety issue: No ]
- Establishment of an image-guided pathway for gynecological cancer radiotherapy [ Time Frame: 2015 ] [ Designated as safety issue: No ]
- Rate of loco-regional control as assessed by CT scan, MRI, and biopsy [ Time Frame: 2015 ] [ Designated as safety issue: No ]
- Quality of life as assessed using EORTC QLQ-C30 and EORTC QLQ Cervical Cancer Specific Module CX 24 questionnaires [ Time Frame: 2015 ] [ Designated as safety issue: No ]
- Rate of disease-free survival [ Time Frame: 2015 ] [ Designated as safety issue: No ]
- Overall survival rate [ Time Frame: 2015 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 154 |
| Study Start Date: | March 2010 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm B
45 Gy/25# external beam pelvic radiotherapy delivered using intensity modulated radiotherapy (IMRT) followed by 11 Gy/2# vaginal vault brachytherapy
|
Radiation: 45 Gy/25 fractions
Arm A 45 Gy/25 fractions pelvic radiotherapy using 3D planned technique followed by 11Gy/2 fractions vaginal vault brachytherapy
|
|
Arm A Control
45 Gy/25# external beam pelvic radiotherapy delivered using a 3-dimensional planned technique followed by 11 Gy/2# vaginal vault brachytherapy
|
Radiation: 45 Gy/25 fractions
Arm A 45 Gy/25 fractions pelvic radiotherapy using 3D planned technique followed by 11Gy/2 fractions vaginal vault brachytherapy
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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 adjuvant chemotherapy has been delivered prior to radiotherapy
- 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
Contacts and Locations| Ireland | |
| Saint Luke's Hospital | Recruiting |
| Dublin, Ireland, 6 | |
| Contact: Contact Person 353-1-406-5000 Charles.Gillham@slh.ie | |
| Principal Investigator: | Charles Gillham, MD | Saint Luke's Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | ICORG- All Ireland Cooperative Oncology Research Group |
| ClinicalTrials.gov Identifier: | NCT01164150 History of Changes |
| Other Study ID Numbers: | CDR0000680805, ICORG-09-06, EU-21048 |
| Study First Received: | July 15, 2010 |
| Last Updated: | September 21, 2012 |
| Health Authority: | Ireland: Research Ethics Committee |
Keywords provided by ICORG- All Ireland Cooperative Oncology Research Group:
|
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 |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Sarcoma, Endometrial Stromal Adenoma Radiation Injuries Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms |
Uterine Diseases Genital Diseases, Female Neoplasms, Complex and Mixed Neoplasms by Histologic Type Sarcoma Neoplasms, Connective and Soft Tissue Endometrial Stromal Tumors Neoplasms, Glandular and Epithelial Wounds and Injuries |
ClinicalTrials.gov processed this record on May 19, 2013