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Hypofractionated Radiotherapy as Primary Therapy for Prostate Cancer (Hypofraction)

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ClinicalTrials.gov Identifier: NCT01921803
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : August 13, 2013
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

Brief Summary:

External beam radiotherapy (RT) is one of the standard curative treatment options for patients with prostate cancer (PC). Several randomised trials have shown excellent long-term biochemical outcome with higher radiation doses. Nowadays, RT for PC commonly consists of delivering 74-80 Gy in 2 Gy fractions, resulting in an overall treatment time of 7-8 weeks. The sensitivity of different tissues to fractionation changes can be quantified through the α/β ratio in the linear-quadratic model. Dose-response analysis of PC patients treated with both external beam RT and brachytherapy has led to the hypothesis that the α/β ratio of PC is lower than for most other tumors and approaches a value characteristic of late responding tissues. Values between 1.2 and 3.9 Gy have been calculated. If the α/β ratio of PC is indeed low, then hypofractionating RT treatments can theoretically maintain high bioequivalent tumor doses, shorten overall treatment time and decrease late toxicities.The advantages in terms of patient convenience and treatment cost are obvious. There is level I evidence that shows that hypofractionated radiotherapy schedules have at least equivalent biochemical outcome with only a small increase in acute but not late toxicity when compared to conventional fractionation RT schedules.

Results on different hypofractionation schedules have been reported, however the optimal hypofractionation is not clear so far. In this randomised trial we would like to compare 2 different radiotherapyschedules: 16 fractions à rato of 4 fractions a week versus 25 fractions à rato of 5 fractions a week. The incidence on acute toxicity and early late toxicity (i.e. within 2 year post radiotherapy) and the impact on quality of life will be registrated and compared. The study will be performed in 2 stages. For stage 1, sample size was calculated to rule out an upper limit of 40% of patients with RTOG grade 2 or worse bowel (GI) complications with an expected rate of 25%, based on a one-stage Fleming-A'Hern design. A power of 83.0% (alpha level 0.038 one-sided) was obtained when including 72 patients per group (144 patients in total). If 22 or more patients out of 72 had grade 2 or worse GI complications, then the study arm was to be rejected. To allow for a dropout of 10%, 160 patients were included in stage 1. Sample size for stage 2 was calculated analogously allowing ruling out an upper limit of 35% of patients with RTOG grade 2 or worse GI complications with an expected rate of 25%. When including 155 patients per group (310 in total) a power of 85.7% (alpha level 0.049 one-sided) was obtained. If 45 or more patients out of 155 had grade 2 or worse GI complications, then the study arm was to be rejected. The sample size for stage 1 and stage 2 combined was set at 346 (173 per group), with a 10% allowance for dropout.


Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: hypofractionation Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 346 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hypofractionated Radiotherapy as Primary Therapy for Prostate Cancer: Randomised Trial Comparing Toxicity Between 2 Different Hypofractionated Schedules
Study Start Date : August 2013
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Arm 1
16 fractions à rato of 4 fractions a week over 4 weeks
Radiation: hypofractionation
Experimental: Arm 2
25 fractions à rato of 5 fractions a week over 5 weeks
Radiation: hypofractionation



Primary Outcome Measures :
  1. acute and early late toxicity [ Time Frame: pre radiotherapy ]
    A maximal incidence of 40% of Grade 2 gastro-intestinal (GI) toxicity is allowed. Evaluation of difference in grade 2 and 3 GI toxicity.

  2. acute and early late toxicity [ Time Frame: 1 month after radiotherapy ]
  3. acute and early late toxicity [ Time Frame: 3 months after radiotherapy ]
  4. acute and early late toxicity [ Time Frame: 6 months after radiotherapy ]
  5. acute and early late toxicity [ Time Frame: 9 months after radiotherapy ]
  6. acute and early late toxicity [ Time Frame: 12 months after radiotherapy ]
  7. acute and early late toxicity [ Time Frame: 18 months radiotherapy ]
  8. acute and early late toxicity [ Time Frame: 24 months radiotherapy ]

Secondary Outcome Measures :
  1. change in quality of life [ Time Frame: from start to 24 months after radiotherapy ]
    • EORTC QLQ-C30 and EORTC QLQ-PR25
    • EQ-5D-5L

  2. cost effectiveness [ Time Frame: 24 months after radiotherapy ]


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with T1-4 N0 M0 prostate cancer

Exclusion Criteria:

  • other no skin cancer diagnosed within 5 years prior to enrolment
  • no informed consent

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): NCT01921803


Contacts
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Contact: Valérie Fonteyne valerie.fonteyne@uzgent.be

Locations
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Belgium
Ghent University Hospital Recruiting
Ghent, Belgium, 9000
Contact: Valerie Fonteyne       valerie.fonteyne@ugent.be   
Sponsors and Collaborators
University Hospital, Ghent
Investigators
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Principal Investigator: Valerie Fonteyne University Hospital, Ghent

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01921803     History of Changes
Other Study ID Numbers: 2013/380
First Posted: August 13, 2013    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases