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There is no randomized controlled trial (RCT) comparing Conformal Radiotherapy (3DCRT) versus the Intensity Modulated Radiotherapy (IMRT) in terms of toxicity and disease control. Data from retrospective studies show that IMRT reduces the risk of severe late complications. More recently, the results from the RTOG 0126 study have also confirmed the benefit from IMRT in reducing acute toxicity for prostate cancer treated with conventional dose escalation. Therefore, to investigate the real clinical benefit of the IMRT over 3DCRT using a hypofractionated schedule in prostate cancer, the investigators developed a RCT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMRT- Hypofractionated schedule 70 Gy/25 fx | Experimental | The IMRT plan consisted of five - seven fields to deliver the same dose prescribed at the isodose line covering 95% of PTV.By the linear-quadratic formula, considering an α/β ratio of 1.5 Gy for prostate cancer, 70 Gy/25 fractions is equivalent to 86 Gy in 43 fractions of 2 Gy. All patients were simulated on CT simulator. |
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| 3DCRT-Hypofractionated schedule 70 Gy/25 fx | Active Comparator | The 3DCRT plan consisted of six fields to deliver a total dose of 70 Gy/ 25 fractions of a single daily dose of 2.8 Gy. By the linear-quadratic formula, considering an α/β ratio of 1.5 Gy for prostate cancer, 70 Gy/25 fractions is equivalent to 86 Gy in 43 fractions of 2 Gy. All patients were simulated on CT simulator. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMRT | Radiation | The IMRT plan consisted of five - seven fields to deliver the same dose prescribed at the isodose line covering 95% of PTV. The 3DCRT plan consisted of six fields to deliver a total dose of 70 Gy/ 25 fractions of a single daily dose of 2.8 Gy. |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal and geniturinary acute toxicity | The primary study outcome was acute treatment reactions from the beginning of treatment to 6 months after the end of treatment. Patients were seen weekly, or as required, during treatment by a radiation oncologist. Acute gastrointestinal (GI) and genitourinary (GU) toxicity were prospectively assessed and graded according to the Radiation Therapy Oncology Group scoring system for the rectum and bladder. | 6 months |
| Gastrointestinal and geniturinary late toxicity | Any toxicity developed after 6 months from radiotherapy treatment was considered as late toxicity. Late gastrointestinal (GI) and genitourinary (GU) toxicity were prospectively assessed and graded according to the Radiation Therapy Oncology Group scoring system for the rectum and bladder. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical control | The Phoenix criteria ( nadir + 2 ng/ml of PSA) was used to define the biochemical control. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gustavo Viani, PhD | FAMEMA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine of Marilia | Marília | São Paulo | Brazil |
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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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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |