Back to resultsIG-VMAT for Localized Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
hypofraction
convention
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostatic Neoplasms, radiotherapy
Eligibility Criteria
Inclusion Criteria:
- Age 50-79
- Histologically confirmed prostate adenocarcinoma
- Clinical stage T1-3N0M0 according to the AJCC 6th edition
- Gleason score must be >5
- KPS >70
- No radical surgery or cryosurgery for prostate cancer
Exclusion Criteria:
- Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. (For example, carcinoma in situ of the bladder or oral cavity is permissible)
- Evidence of distant metastases
- Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
- Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
- Previous or concurrent cytotoxic chemotherapy for prostate cancer
Sites / Locations
- Beijing HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
hypofraction
convention
Arm Description
70 Gy in 28 fractions over 5.6 weeks
80Gy in 40 fractions over 8 weeks
Outcomes
Primary Outcome Measures
Biochemical progression free survival
Number of participants who are free of biochemical relapse after a specified duration of time.Phoenix definition of biochemical failure.
Secondary Outcome Measures
Incidence of "acute" adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v. 4.0
Time to "late" grade 2+ adverse events as assessed by NCI CTCAE v. 4.0
Overall Survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02934685
Brief Title
IG-VMAT for Localized Prostate Cancer
Official Title
A Phase III Randomized Study of Hypofractionated Image-guided Volumetric Modulated Arc Radiotherapy (IG-VMAT) Versus Conventionally Fractionated IG-VMAT in Patients With Localized Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
May 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To determine if hypofractionated IG-VMAT (70 Gy in 28 fractions over 5.6 weeks) will result in disease-free survival (DFS) that is no worse than DFS following conventionally fractionated IG-VMAT (80Gy in 40 fractions over 8 weeks) in patients treated for localized prostate cancer. Analysis the local progression, disease-specific survival (DFS), freedom from biochemical recurrence (FFBR), and overall survival (OS) of two groups. Observe the incidence of GI and GU toxicity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostatic Neoplasms, radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hypofraction
Arm Type
Experimental
Arm Description
70 Gy in 28 fractions over 5.6 weeks
Arm Title
convention
Arm Type
Active Comparator
Arm Description
80Gy in 40 fractions over 8 weeks
Intervention Type
Radiation
Intervention Name(s)
hypofraction
Intervention Description
70 Gy in 28 fractions over 5.6 weeks
Intervention Type
Radiation
Intervention Name(s)
convention
Intervention Description
80Gy in 40 fractions over 8 weeks
Primary Outcome Measure Information:
Title
Biochemical progression free survival
Description
Number of participants who are free of biochemical relapse after a specified duration of time.Phoenix definition of biochemical failure.
Time Frame
up to 18 months
Secondary Outcome Measure Information:
Title
Incidence of "acute" adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v. 4.0
Time Frame
From the start of radiation therapy (RT) to first occurrence of worse severity of adverse event within 30 days after the completion of RT
Title
Time to "late" grade 2+ adverse events as assessed by NCI CTCAE v. 4.0
Time Frame
From the date of completion of RT to the date of first grade 2 or above adverse event occurring 30 days after the completion of RT
Title
Overall Survival
Time Frame
up to 5 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 50-79
Histologically confirmed prostate adenocarcinoma
Clinical stage T1-3N0M0 according to the AJCC 6th edition
Gleason score must be >5
KPS >70
No radical surgery or cryosurgery for prostate cancer
Exclusion Criteria:
Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. (For example, carcinoma in situ of the bladder or oral cavity is permissible)
Evidence of distant metastases
Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
Previous or concurrent cytotoxic chemotherapy for prostate cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiuzi Zhong
Phone
+86 13810428903
Email
drzhongqiuzi@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaofeng Li, director
Organizational Affiliation
Beijing Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaofeng Li
Phone
+86 13701062301
Email
lgf6243@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
IG-VMAT for Localized Prostate Cancer
We'll reach out to this number within 24 hrs