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IG-VMAT for Localized Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02934685
Recruitment Status : Recruiting
First Posted : October 17, 2016
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Gaofing Li, Beijing Hospital

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: hypofraction Radiation: convention Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2016
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Overall Survival [ Time Frame: up to 5 years ]


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Ages Eligible for Study:   50 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02934685


Contacts
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Contact: Qiuzi Zhong +86 13810428903 drzhongqiuzi@163.com

Locations
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China
Beijing Hospital Recruiting
Beijing, China
Contact: Gaofeng Li    +86 13701062301    lgf6243@163.com   
Sponsors and Collaborators
Beijing Hospital
Investigators
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Principal Investigator: Gaofeng Li, director Beijing Hospital
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Responsible Party: Gaofing Li, director of radiotherapy department, Beijing Hospital
ClinicalTrials.gov Identifier: NCT02934685    
Other Study ID Numbers: BeijingH-01-RT
First Posted: October 17, 2016    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Gaofing Li, Beijing Hospital:
Prostatic Neoplasms
radiotherapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases