IG-VMAT for Localized Prostate Cancer

November 16, 2016 updated by: Gaofing Li, Beijing Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hypofraction
70 Gy in 28 fractions over 5.6 weeks
Radiation: hypofraction
70 Gy in 28 fractions over 5.6 weeks
Active Comparator: convention
80Gy in 40 fractions over 8 weeks
Radiation: convention
80Gy in 40 fractions over 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical progression free survival
Time Frame: up to 18 months
Number of participants who are free of biochemical relapse after a specified duration of time.Phoenix definition of biochemical failure.
up to 18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: up to 5 years
up to 5 years
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
From the start of radiation therapy (RT) to first occurrence of worse severity of adverse event within 30 days after the completion of RT
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Hospital

Investigators

  • Principal Investigator: Gaofeng Li, director, Beijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

July 11, 2016

First Submitted That Met QC Criteria

October 13, 2016

First Posted (Estimate)

October 17, 2016

Study Record Updates

Last Update Posted (Estimate)

November 18, 2016

Last Update Submitted That Met QC Criteria

November 16, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BeijingH-01-RT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on hypofraction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe