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
| ISRCTN | ISRCTN15849938 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15849938 |
| Secondary identifying numbers | MEC 06/268, NL865 (NTR879) |
- Submission date
- 26/02/2007
- Registration date
- 26/02/2007
- Last edited
- 22/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M A D Haverkort
Scientific
Scientific
Academisch Medisch Centrum
Afdeling Radiotherapie
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 566 3750 |
|---|---|
| m.a.haverkort@amc.nl |
Study information
| Study design | Prospective phase II modeling study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Single-centre |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | 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 |
| Study objectives | To 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 Computed Tomography (CT) scans (adaptive margin strategy) is required instead of 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. |
| Ethics approval(s) | Approval received from the local medical ethics committee (Medische Etische Commissie Academisch Medisch Centrum) on the 19th December 2006 (ref: MEC 06/268). |
| Health condition(s) or problem(s) studied | External beam radiotherapy, prostatic neoplasms, rectal toxicity, position verification |
| Intervention | Before the start of the treatment four gold seeds will be implanted in the prostate of the patients. Treatment consists of external beam radiotherapy (77 - 78 Gy) 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 five 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. |
| Intervention type | Other |
| Primary outcome measure | D30% rectal wall (the minimum dose in 30% of the rectal wall that receives the highest dose) from the cumulative dose-volume-histograms |
| Secondary outcome measures | 1. D10% rectal wall, D50% rectal wall, D70% rectal wall 2. D mean anal canal 3. Crude cost analysis |
| Overall study start date | 01/02/2007 |
| Completion date | 01/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Male |
| Target number of participants | 20 |
| Total final enrolment | 20 |
| Key inclusion criteria | 1. Histologically proven localised (cT1-3) adenocarcinoma of the prostate 2. Primary treatment for the prostate cancer with more than 70 Gy radiotherapy with curative intent 3. World Health Organisation (WHO) performance status zero to two 4. The administration of concomitant hormonal therapy is allowed, however only if started more than six months before radiotherapy to limit the possibility of shrinkage of the prostate during the course of radiotherapy 5. Be able to lie in lithotomy position 6. Meet all Magnetic Resonance Imaging (MRI) safety criteria |
| Key exclusion criteria | 1. 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 Transurethral Resection of the Prostate (TUR-P) in the last three 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. coumarins or heparins), however the use of anti-platelet therapy is allowed 7. No coagulation disorder |
| Date of first enrolment | 01/02/2007 |
| Date of final enrolment | 01/02/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academisch Medisch Centrum
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Sponsor information
Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Radiotherapy
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Website | http://www.amc.uva.nl/ |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Hospital/treatment centre
Academic Medical Centre (AMC) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/06/2011 | 22/09/2021 | Yes | No |
Editorial Notes
22/09/2021: Publication reference added.
