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| Name | Class |
|---|---|
| Norwegian University of Science and Technology | OTHER |
| Alesund Hospital | OTHER |
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The clinical importance of cone beam computer tomography based image guided radiotherapy (CT- IGRT) has not been established. The primary aim of the present trial is to investigate whether CT- IGRT and consequently reduced safety margins reduces the rectal side effects from curative, high dose radiotherapy in prostate cancer. Any impact of the reduced planning target volume in the CT- IGRT arm on biochemical freedom from disease will be evaluated as secondary outcome.
An open randomised phase III trial. The included men will be randomised to receive curative radiotherapy to 78 Gy in 39 fractions with weekly orthogonal position verification and standard safety margins (10-15 mm) or 78 Gy in 39 fractions with daily CT position verification and reduced safety margins (7mm).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| radiotherapy daily reduced | Experimental | radiotherapy, with daily CT position verification and reduced safety margins |
|
| radiotherapy weekly standard | Active Comparator | radiotherapy, with weekly orthogonal position verification and standard safety margins |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiotherapy daily verification reduced safety margins | Radiation | curative radiotherapy to 78 Gy in 39 fractions with daily CT position verification and reduced safety margins (7mm) |
| Measure | Description | Time Frame |
|---|---|---|
| Acute rectal side effects | FWUO94 | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from biochemical failure | 3 years | |
| Overall survival | up to 10 years | |
| Cancer specific survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jo Ã… Lund, MD PhD | St Olavs Hospital, University Hospital, Trondheim, Norway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ã…lesund Sykehus | Ã…lesund | Norway | ||||
| St Olavs Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29398152 | Result | Tondel H, Lund JA, Lydersen S, Wanderas AD, Aksnessaether B, Jensen CA, Kaasa S, Solberg A. Radiotherapy for prostate cancer - Does daily image guidance with tighter margins improve patient reported outcomes compared to weekly orthogonal verified irradiation? Results from a randomized controlled trial. Radiother Oncol. 2018 Feb;126(2):229-235. doi: 10.1016/j.radonc.2017.10.029. Epub 2018 Feb 3. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| radiotherapy weekly verification standard safety margins | Radiation | curative radiotherapy to 78 Gy in 39 fractions with weekly orthogonal position verification and standard safety margins (10-15 mm) |
|
| up to 10 years |
| Late genitourinary and rectal side effects | up to 10 years |
| Acute genitourinary side effects | 10 weeks |
| quality of life | HRQoL | up to 10 years |
| Trondheim |
| Norway |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |