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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00003026
Other study ID # EORTC-22961
Secondary ID EORTC-22961EORTC
Status Completed
Phase Phase 3
First received November 1, 1999
Last updated June 29, 2012
Start date April 1997

Study information

Verified date June 2012
Source European Organisation for Research and Treatment of Cancer - EORTC
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using triptorelin may fight prostate cancer by reducing the production of androgens.

PURPOSE: Randomized phase III trial to compare the effectiveness of long-term hormone therapy and triptorelin with no further treatment in treating patients who have advanced prostate cancer previously treated with radiation therapy and 6 months of androgen suppression.


Description:

OBJECTIVES:

- Determine the best hormonal scheme to be associated with pelvic radiotherapy in the curative management of prostatic carcinoma for hormonal treatment with regards to treatment outcome (overall survival, clinical disease free survival, local regional control), quality of life (treatment side effects, sexual function), and health economy (cost effectiveness ratio).

OUTLINE: This is a randomized, multicenter study.

Patients receive external radiation for 5 weeks, followed by a pelvic boost given for 2 weeks and a 6 month combined androgen blockage initiated at the onset of external irradiation. Flutamide (Eulexin) or bicalutamide (Casodex) may be used as the antiandrogens. Antiandrogen treatment starts 1 week before the first injection of triptorelin.

Patients are then randomized to one of two treatment arms.

- Arm I: Patients receive no further treatment.

- Arm II: Patients receive antiandrogen for 2.5 years plus and LHRH analogue (triptorelin) administered every 3 months. Patients then continue the LHRH analogue alone for an additional 2.5 years in the absence of disease progression.

Patients are followed every 6 months for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 966 patients will be accrued over 5 years.


Recruitment information / eligibility

Status Completed
Enrollment 966
Est. completion date
Est. primary completion date September 2001
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the prostate

- T1c-T2a-b, N1-2 or pN1-2 (after pelvic lymphadenectomy)

- T2c-T4, N0-2

- Prior external radiotherapy for locally advanced prostatic carcinoma required

- Prior hormone therapy (6 months of combined androgen blockade) for locally advanced prostatic carcinoma required with PSA no greater than 150 ng/mL before administration

- No progressive disease after the 6 months of combined androgen blockage

- No stages T1c/T2a-b with a negative pelvic lymph nodes status that is assessed clinically or surgically

- No lymph node involvement to common iliac and/or periaortic lymph nodes (M1a)

- No external iliac lymph node metastasis more than 5 cm in greatest dimension (N3)

- No distant metastases

PATIENT CHARACTERISTICS:

Age:

- Any age

Performance status:

- WHO 0-2

Life expectancy:

- At least 5 years

Hematopoietic:

- Hemoglobin at least 10 g/dL

- WBC at least 2,000/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- No prior or concurrent cancers other than basal cell skin cancer

- No serious nonmalignant disease resulting in a life expectancy of less than 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior biologic therapy for prostate cancer

Chemotherapy

- No prior chemotherapy for prostate cancer

Endocrine therapy

- See Disease Characteristics

Radiotherapy

- See Disease Characteristics

Surgery

- See Disease Characteristics

Study Design

Allocation: Randomized, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
bicalutamide

flutamide

triptorelin

Radiation:
radiation therapy


Locations

Country Name City State
Belgium Academisch Ziekenhuis der Vrije Universiteit Brussel Brussels
Belgium Institut Jules Bordet Brussels (Bruxelles)
Belgium Universitair Ziekenhuis Antwerpen Edegem
Belgium Universitair Ziekenhuis Gent Ghent
Belgium Virga Jesse Hospital Hasselt
Belgium U.Z. Gasthuisberg Leuven
Israel Rambam Medical Center Haifa
Malta St. Luke's Hospital and Medical School Guardamangia
Netherlands Groot Ziekengasthuis 's-Hertogenbosch 's-Hertogenbosch
Netherlands Academisch Medisch Centrum Amsterdam
Netherlands Onze Lieve Vrouwe Gasthuis Amsterdam
Netherlands Academisch Ziekenhuis Groningen Groningen
Netherlands Academisch Ziekenhuis Maastricht Maastricht
Netherlands St. Elisabeth Ziekenhuis Tilburg
Russian Federation Medical Radiological Research Center Obninsk
Turkey Marmara University Hospital Istanbul
United Kingdom City General Hospital Stoke-On-Trent England

Sponsors (1)

Lead Sponsor Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  Israel,  Malta,  Netherlands,  Russian Federation,  Turkey,  United Kingdom, 

References & Publications (3)

Bolla M, de Reijke TM, Van Tienhoven G, Van den Bergh AC, Oddens J, Poortmans PM, Gez E, Kil P, Akdas A, Soete G, Kariakine O, van der Steen-Banasik EM, Musat E, Piérart M, Mauer ME, Collette L; EORTC Radiation Oncology Group and Genito-Urinary Tract Canc — View Citation

Bolla M, van Tienhoven G, de Reijke TM, et al.: Concomitant and adjuvant androgen deprivation (ADT) with external beam irradiation (RT) for locally advanced prostate cancer: 6 months versus 3 years ADT--results of the randomized EORTC phase III trial 2296

Giraud JY, Dusserre A, Conil M, et al.: Results of the dummy-run of EORTC trial no.22961: a phase III study of long term hormonal treatment on locally advanced prostatic carcinoma treated by radiation therapy and a 6 months CAB. [Abstract] Int J Radiat On

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