Shorter Radiation Schedule for the Treatment of Prostate Cancer

NCT ID: NCT00201916

Last Updated: 2010-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

936 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-03-31

Study Completion Date

2009-12-31

Brief Summary

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To improve the management of patients with early stage prostate cancer.

Detailed Description

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To compare the efficacy of a shorter radiation fractionation schedule to the prostate (5250 cGy/20 fractions over 28 days) with a conventional schedule (6600 cGy/33 fractions over 45 days) in men receiving radiotherapy for Stage T1a moderately or poorly differentiated, or T1b, T1c, or T2 prostate cancer. The primary outcome is local control in the prostate and secondary outcomes include toxicity, disease free survival, survival, quality of life and economics.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

5250 cGy in 20 fractions over 28 days

Group Type EXPERIMENTAL

5250 cGy/20 fractions over 28 days

Intervention Type PROCEDURE

see above

2

6600 cGy in 33 fractions over 45 days

Group Type ACTIVE_COMPARATOR

6600 cGy/33 fractions over 45 days

Intervention Type PROCEDURE

see above

Interventions

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5250 cGy/20 fractions over 28 days

see above

Intervention Type PROCEDURE

6600 cGy/33 fractions over 45 days

see above

Intervention Type PROCEDURE

Other Intervention Names

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short fractionation schedule standard

Eligibility Criteria

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Inclusion Criteria

* histologic diagnosis of adenocarcinoma of the prostate with no evidence of metastatic disease to the nodes, bone or lung
* stage T1a moderately or poorly differentiated, T1b, T1c or T2 by the current UICC-TNM classification

Exclusion Criteria

* PSA \> 40 mcg/L
* previous therapy for carcinoma of the prostate other than biopsy or TURP, including patients previously on hormone therapy for treatment of their prostate cancer
* prior or active malignancy other than non-melanoma skin cancer; or colon or thyroid cancer treated a minimum of five years prior to study entry and presumed cured
* simulated volume exceeds 1000 cm3
* previous pelvic radiotherapy
* inflammatory bowel disease
* serious non-malignant disease which would preclude radiotherapy or surgical biopsy
* geographic inaccessibility for follow-up
* psychiatric or addictive disorder which would preclude obtaining informed consent or adherence to protocol
* unable to commence radiation therapy within 26 weeks of the date of last prostatic biopsy
* failure to give informed consent to participate in the study
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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NCIC Clinical Trials Group

NETWORK

Sponsor Role collaborator

Ontario Clinical Oncology Group (OCOG)

OTHER

Sponsor Role lead

Responsible Party

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Ontario Clinical Oncology Group

Principal Investigators

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Himu Lukka, MD

Role: STUDY_CHAIR

Juravinski Cancer Centre

Charles Hayter, MD

Role: STUDY_CHAIR

Toronto Sunnybrook Regional Cancer Centre

Mark Levine, MD

Role: PRINCIPAL_INVESTIGATOR

Ontario Clinical Oncology Group (OCOG)

Locations

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B.C. Cancer Agency - Fraser Valley Cancer Centre

Surrey, British Columbia, Canada

Site Status

B. C. Cancer Agency - Vancouver Cancer Clinic

Vancouver, British Columbia, Canada

Site Status

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Site Status

Dr. Leon Richard Oncology Centre

Moncton, New Brunswick, Canada

Site Status

Saint John Regional Hospital

Saint John, New Brunswick, Canada

Site Status

Newfoundland Cancer Clinic

St. John's, Newfoundland and Labrador, Canada

Site Status

Nova Scotia Cancer Centre

Halifax, Nova Scotia, Canada

Site Status

Northeastern Ontario Regional Cancer Centre

Greater Sudbury, Ontario, Canada

Site Status

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Site Status

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Kingston, Ontario, Canada

Site Status

London Regional Cancer Centre

London, Ontario, Canada

Site Status

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, Canada

Site Status

Toronto-Sunnybrook Regional Cancer Centre

Toronto, Ontario, Canada

Site Status

University Health Network -Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

Windsor Regional Cancer Centre

Windsor, Ontario, Canada

Site Status

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

References

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Lukka H, Hayter C, Julian JA, Warde P, Morris WJ, Gospodarowicz M, Levine M, Sathya J, Choo R, Prichard H, Brundage M, Kwan W. Randomized trial comparing two fractionation schedules for patients with localized prostate cancer. J Clin Oncol. 2005 Sep 1;23(25):6132-8. doi: 10.1200/JCO.2005.06.153.

Reference Type RESULT
PMID: 16135479 (View on PubMed)

Other Identifiers

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CAN-OCOG-V95-0687

Identifier Type: -

Identifier Source: secondary_id

OCOG-1995-PR.5

Identifier Type: -

Identifier Source: org_study_id

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