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Trial Comparing Intensity Modulated Radiotherapy Versus Conformal Radiotherapy to Treat Prostate Cancer With Hypofractionated Schedule

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
IMRT
Sponsored by
Gustavo Viani Arruda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Hypofractionated schedule, Intensity Modulated Radiotherapy, Conformal radiotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with diagnosis of prostate cancer
  • With age between 18-75 years classified in low
  • Intermediate and high-risk group according to their Gleason score
  • T stage and initial PSA (iPSA).
  • Low risk group included patients with Gleason score <7 / stage T1-T2a, and iPSA <10 ng/mL.
  • Intermediate risk included Gleason score < 7, or Stage T1-T2b, or iPSA level of 10-20 ng/mL
  • High-risk patients with Gleason score >7, or Stage > T2b, or iPSA >20 ng/mL.
  • All patients classified as high risk was submitted to the bone scans.

Exclusion Criteria:

  • Patients with metastases
  • Prior history of prostatectomy
  • Pelvic radiotherapy treatment
  • Chemotherapy treatment were excluded of this trial.

Sites / Locations

  • Faculty of Medicine of Marilia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IMRT- Hypofractionated schedule 70 Gy/25 fx

3DCRT-Hypofractionated schedule 70 Gy/25 fx

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Biochemical control
The Phoenix criteria ( nadir + 2 ng/ml of PSA) was used to define the biochemical control.

Full Information

First Posted
September 29, 2014
Last Updated
October 3, 2014
Sponsor
Gustavo Viani Arruda
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1. Study Identification

Unique Protocol Identification Number
NCT02257827
Brief Title
Trial Comparing Intensity Modulated Radiotherapy Versus Conformal Radiotherapy to Treat Prostate Cancer With Hypofractionated Schedule
Official Title
Randomized Trial Comparing Intensity Modulated Radiotherapy Versus Conformal Radiotherapy to Treat Prostate Cancer With Hypofractionated Schedule.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gustavo Viani Arruda

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Hypofractionated schedule, Intensity Modulated Radiotherapy, Conformal radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMRT- Hypofractionated schedule 70 Gy/25 fx
Arm Type
Experimental
Arm Description
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.
Arm Title
3DCRT-Hypofractionated schedule 70 Gy/25 fx
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
IMRT
Other Intervention Name(s)
3DCRT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gastrointestinal and geniturinary acute toxicity
Description
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.
Time Frame
6 months
Title
Gastrointestinal and geniturinary late toxicity
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Biochemical control
Description
The Phoenix criteria ( nadir + 2 ng/ml of PSA) was used to define the biochemical control.
Time Frame
3 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with diagnosis of prostate cancer With age between 18-75 years classified in low Intermediate and high-risk group according to their Gleason score T stage and initial PSA (iPSA). Low risk group included patients with Gleason score <7 / stage T1-T2a, and iPSA <10 ng/mL. Intermediate risk included Gleason score < 7, or Stage T1-T2b, or iPSA level of 10-20 ng/mL High-risk patients with Gleason score >7, or Stage > T2b, or iPSA >20 ng/mL. All patients classified as high risk was submitted to the bone scans. Exclusion Criteria: Patients with metastases Prior history of prostatectomy Pelvic radiotherapy treatment Chemotherapy treatment were excluded of this trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustavo Viani, PhD
Organizational Affiliation
FAMEMA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine of Marilia
City
Marilia
State/Province
Sao Paulo
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Trial Comparing Intensity Modulated Radiotherapy Versus Conformal Radiotherapy to Treat Prostate Cancer With Hypofractionated Schedule

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