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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02257827
• Other study ID #: FAMEMA-0913
• Status: Completed
• Phase: Phase 3
• First received: September 29, 2014
• Last updated: October 3, 2014
• Start date: January 2009
• Est. completion date: January 2013

Study information

• Verified date: October 2014
• Source: Marilia Medicine School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• IMRT
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.

Locations

Country	Name	City	State
Brazil	Faculty of Medicine of Marilia	Marilia	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Gustavo Viani Arruda

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Biochemical control	The Phoenix criteria ( nadir + 2 ng/ml of PSA) was used to define the biochemical control.	3 years	No