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Which correction protocol gives the lowest cumulative rectal dose in prostate cancer patients who are treated with external beam radiotherapy? A phase II Modelling study


- candidate number2426
- NTR NumberNTR879
- ISRCTNISRCTN15849938
- Date ISRCTN created26-feb-2007
- date ISRCTN requested21-feb-2007
- Date Registered NTR24-jan-2007
- Secondary IDsMEC 06/268 
- Public TitleWhich correction protocol gives the lowest cumulative rectal dose in prostate cancer patients who are treated with external beam radiotherapy? A phase II Modelling study
- Scientific TitleWhich correction protocol gives the lowest cumulative rectal dose in prostate cancer patients who are treated with external beam radiotherapy? A phase II Modelling study
- ACRONYMPosition correction to lower rectal dose
- hypothesisTo reduce cumulative radiation dose in the rectum in prostate cancer patients who are treated with curative intent using external beam radiotherapy. We will investigate whether position correction based on implanted gold markers or re-planning based on sequential CT scans (adaptive margin strategy) is required in stead of to standard position correction protocols based on bony anatomy. With this knowledge we intend to develop a new treatment protocol for patients with prostate cancer for our department.
- Healt Condition(s) or Problem(s) studiedProstatic neoplasms, External beam radiotherapy, Rectal toxicity, Position verification
- Inclusion criteriaHistologically proven localized (cT1-3) adenocarcinoma of the prostate 1. Primary treatment for the prostate cancer with more than 70 Gy radiotherapy with curative intent; 2. WHO performance status 0-2; 3. The administration of concomitant hormonal therapy is allowed, however only if started more than 6 months before radiotherapy to limit the possibility of shrinkage of the prostate during the course of radiotherapy; 4. Be able to lie in lithotomy position; 5. Meet all MRI safety criteria.
- Exclusion criteria1. No hip prosthesis; 2. No involvement of pelvic lymph node assessed by CT scan or laparoscopic surgery; 3. No evidence of distant metastases; 4. No TUR-P in the last 3 months; 5. No anorectal surgery in the past or other situations in which the anorectal anatomy is abnormal; 6. No use of anticoagulation therapy (i.e. coumarines or heparins), however the use of anti-platelet therapy is allowed; 7. No coagulation disorder.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-feb-2007
- planned closingdate1-feb-2008
- Target number of participants20
- Interventions11 CT scans Patients will be treated according to standard care with high dose intensity modulated radiotherapy and gold marker based position correction. Furthermore they will undergo CT scans in treatment position daily during the first week and weekly thereafter. These data will be used to do modelling for the three correction arms.
- Primary outcomeD30% rectal wall (de minimum dose in 30% of the rectal wall that receives the highest dose) from the cumulative dose-volume-histograms
- Secondary outcome1. D10% rectal wall, D50% rectal wall, D70% rectal wall; 2. D mean anal canal; 3. Crude cost analysis
- Timepoints
- Trial web sitenot applicable
- statusplanned
- CONTACT FOR PUBLIC QUERIES M.A.D. Haverkort
- CONTACT for SCIENTIFIC QUERIES B.R. Pieters
- Sponsor/Initiator Academic Medical Center (AMC), Department of Radiotherapy
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Radiotherapy
- PublicationsN/A
- Brief summaryA prospective phase II modeling study will be undertaken to determine the cumulative radiation dose in the rectum. A position correction protocol based on implanted gold seeds and an adaptive margin strategy based on prostate and rectum delineation on sequential CT scans with the standard position correction based on bony anatomy will be compared. Twenty consecutive prostate cancer patients without metastasis who have given informed consent will be included. Before the start of the treatment 4 gold seeds will be implanted in the prostate of the patients. Treatment consists of external beam radiotherapy (77-78Gy) with curative intent. During radiotherapy the prostate position will be measured daily using portal imaging (PI) of the gold seeds and bony anatomy and treatment position corrections will be performed using standard daily offline correction protocols for optimal prostate treatment. In addition to the standard treatment, a CT scan will be performed every day during the first week and once a week thereafter. After the first week an ‘adaptive margin radiotherapy’ (AMRT) treatment plan will be made, considering both averaged prostate and rectum positions in the first 5 scans. The cumulative rectum dose will be computed for the original treatment plan, considering repositioning based on PI for bony anatomy and markers and considering the adaptive margin strategy. These results will indicate if PI position verification on markers is sufficient to achieve adequate rectum sparing, or whether an additional re-planning based on adaptive margin strategy is required.
- Main changes (audit trail)
- RECORD24-jan-2007 - 26-feb-2007


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