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Safety Study of Pelvic and Prostatic SIB-IMRT With Long-term Androgen Deprivation for High Risk Localized Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01704027
Recruitment Status : Terminated (termination of the trial after interim analysis. the main criterion could not be reached)
First Posted : October 11, 2012
Last Update Posted : September 18, 2014
Sponsor:
Information provided by (Responsible Party):
Centre Georges Francois Leclerc

Tracking Information
First Submitted Date  ICMJE October 2, 2012
First Posted Date  ICMJE October 11, 2012
Last Update Posted Date September 18, 2014
Study Start Date  ICMJE October 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2012)
Number of Participants with Acute urinary and rectal toxicities as a Measure of treatment specific Safety and Tolerability [ Time Frame: From start of radiotherapy to six months after the end of radiotherapy ]
Acute urinary and rectal toxicities will be assessed according to the NCI CTCAE v4.0 quotation each week during radiotherapy treatment period up to six months after the end of the radiotherapy treatment period.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01704027 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2012)
  • To evaluate the late urinary and rectal toxicities [ Time Frame: for each patient every 6 months after the end of radiotherapy up to 5 years. ]
  • Evaluate the 5-year biochemical-free survival [ Time Frame: for each patient from zero day up to 7 day after the end of radiotherapy, 6 weeks, 3 months, and every 6 months after the end of radiotherapy up to 5 years. ]
  • Evaluate the metastase-free survival [ Time Frame: for each patient from zero day up to 7 day after the end of radiotherapy, 6 weeks, 3 months, and every 6 months after the end of radiotherapy up to 5 years. ]
  • To evaluate the specific survival [ Time Frame: for each patient from inclusion up to 5 years after the end of radiotherapy. ]
  • To evaluate the overall survival [ Time Frame: for each patient from inclusion up to 5 years after the end of radiotherapy. ]
  • To evaluate the quality of life [ Time Frame: inclusion day, from zero day up to 7 day after the end of radiotherapy, 6 weeks after the end of the radiotherapy, 3 months after the end of the radiotherapy, every 6 months after the end of radiotherapy up to 5 years. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Pelvic and Prostatic SIB-IMRT With Long-term Androgen Deprivation for High Risk Localized Prostate Cancer
Official Title  ICMJE Prospective Phase II Study Evaluating the Feasibility of a Conformational Pelvic and Prostatic Radiotherapy With Simultaneous Integrated Boost Modulated-intensity Arctherapy (SIB-IMAT) in Combination With Long Term Androgen Deprivation for High Risk Localized Prostate Cancer.
Brief Summary The purpose of this study is to evaluate the incidence of urinary and rectal acute side effects of a pelvic and prostatic intensity-modulated arctherapy with simultaneous integrated boost (SIB-IMRT)combined with long-term androgen deprivation for patients with high risk localized prostate cancer
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Radiation: Simultaneous integrated boost intensity-modulated arctherapy

    Three dose levels will be delivered at each fraction, 5 days a week, 30 fractions :

    • Pelvis : 55,5 Gy (1,85 Gy/fr)
    • Seminal vesicles : 66 Gy (2,2 Gy/fr)
    • Prostate : 72 Gy (2,4 Gy/fr)
  • Drug: Androgen deprivation
    Patients will received androgen deprivation for a maximum of three years. This treatment can start six months before radiotherapy and at least the day one of radiotherapy.
Study Arms  ICMJE Experimental: Radiotherapy
Patient will receive a pelvic and prostatic simultaneous integrated boost intensity-modulated arctherapy (SIB-IMAT) in combination with three years of androgen deprivation
Interventions:
  • Radiation: Simultaneous integrated boost intensity-modulated arctherapy
  • Drug: Androgen deprivation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 17, 2014)
28
Original Estimated Enrollment  ICMJE
 (submitted: October 9, 2012)
54
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Histologically confirmed adenocarcinoma of the prostate
  2. High risk localized adenocarcinoma defined by at least one of the following criteria:

    • Clinical stage T2c, T3 or T4
    • Gleason score ≥ 8
    • Prostate-specific antigen (PSA)≥ 20 ng/ml and ≤ 100 ng/ml
  3. Patient cN0, pN0 or Nx (negative lymphadenectomy or no lymphadenectomy)
  4. No pelvic adenopathy ≥ 15 mm on CT or MRI,
  5. Absence of bone and/or visceral metastasis
  6. Androgen deprivation beginning no later than the day of radiotherapy and up to six months before irradiation
  7. Absence of prior pelvic radiotherapy,
  8. Absence of surgical treatment of prostate cancer except transurethral resection performed within 4 months minimum before radiotherapy,
  9. Age ≥ 18 years and ≤ 85 years
  10. ECOG performance status ≤ 1,
  11. Estimated life expectancy > 5 years
  12. Membership of a social security system,
  13. Signed informed consent.

Exclusion Criteria:

  1. Prostate cancer histology other than adenocarcinoma,
  2. pN1 patients (lymph node dissection after histologically proven)
  3. PSA > 100 ng/ml
  4. History of cancer within 5 years prior to trial entry (with the exception of basal cell carcinoma skin)
  5. Patient with severe hypertension uncontrolled by appropriate treatment (≥ 160 mm Hg systolic and / or ≥ 90 mm Hg diastolic)
  6. Contra-indication for pelvic irradiation (eg scleroderma, chronic inflammatory disease of the digestive tract, etc ...)
  7. Contra-indication to agonists or antagonists of LH-RH
  8. Bilateral hip prosthesis,
  9. Patients already included in another clinical trial with an experimental molecule,
  10. Persons deprived of liberty or under guardianship
  11. Unable to undergo medical test for geographical, social or psychological.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01704027
Other Study ID Numbers  ICMJE 2012-A00694-39
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Georges Francois Leclerc
Study Sponsor  ICMJE Centre Georges Francois Leclerc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Etienne MARTIN, MD Centre Georges-François Leclerc
PRS Account Centre Georges Francois Leclerc
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP