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Radiation Therapy Compared With No Further Treatment Following Surgery in Treating Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 3

Locations

Belgium

Study Type

Interventional

Intervention

low-LET photon therapy

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically documented invasive adenocarcinoma of the prostate staged pT3 pN0 after radical prostatectomy Preoperative staging must have been T0-3 N0 M0 based on physical exam, chest x-ray, bone scan, CT or MRI of entire pelvis and abdomen, and serum PSA At least 1 of the following features must be present: Complete capsule invasion (i.e., perforation) Positive surgical margins (microscopic or gross) Seminal vesicle invasion Radiotherapy must begin within 16 weeks following surgery, after recovery of urinary function PATIENT CHARACTERISTICS: Age: 75 and under Performance status: WHO 0-2 Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other malignancies PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No more than 4 months of preoperative hormonal therapy Radiotherapy: Not specified Surgery: Radical prostatectomy required within 12 weeks with recovery of urinary function

Sites / Locations

U.Z. Gasthuisberg

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002511

First Posted

November 1, 1999

Last Updated

October 15, 2012

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

1. Study Identification

Unique Protocol Identification Number

NCT00002511

Brief Title

Radiation Therapy Compared With No Further Treatment Following Surgery in Treating Patients With Prostate Cancer

Official Title

PHASE III STUDY OF POST-OPERATIVE EXTERNAL RADIOTHERAPY IN PATHOLOGICAL STAGE T3 N0 PROSTATIC CARCINOMA

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

December 1992 (undefined)

Primary Completion Date

December 2001 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for prostate cancer. PURPOSE: Randomized phase III trial to compare radiation therapy with no further treatment in treating patients with stage III prostate cancer following radical prostatectomy.

Detailed Description

OBJECTIVES: Compare local recurrence rates, acute and late morbidity, overall survival, disease-free survival, and cancer-related survival of patients with pT3 pN0 adenocarcinoma of the prostate randomized following radical prostatectomy to postoperative conventional pelvic irradiation (60 Gy) vs no further treatment until relapse. Better define the selective pathologic indications for radiotherapy in patients with pT3 pN0 disease. OUTLINE: This is a randomized study. Arm I: Patients undergo radiotherapy daily, 5 days a week, for 5 weeks, followed by boost radiotherapy for 1-1.4 weeks. Arm II: Patients are observed. Local relapse is treated with conventional pelvic radiotherapy. Patients are followed every 3 months during the first postoperative year, every 6 months until the fifth year, and annually thereafter. PROJECTED ACCRUAL: A total of 1000 patients will be accrued for this study within 7.5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Enrollment

1005 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Radiation

Intervention Name(s)

low-LET photon therapy

10. Eligibility

Sex

All

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michel Bolla, MD

Organizational Affiliation

CHU de Grenoble - Hopital de la Tronche

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Hein van Poppel, MD, PhD

Organizational Affiliation

University Hospital, Gasthuisberg

Official's Role

Study Chair

Facility Information:

Facility Name

U.Z. Gasthuisberg

City

Leuven

ZIP/Postal Code

B-3000

Country

Belgium

12. IPD Sharing Statement

Citations:

PubMed Identifier

18602742

Citation

Ganswindt U, Stenzl A, Bamberg M, Belka C. Adjuvant radiotherapy for patients with locally advanced prostate cancer--a new standard? Eur Urol. 2008 Sep;54(3):528-42. doi: 10.1016/j.eururo.2008.06.059. Epub 2008 Jun 23.

Results Reference

background

PubMed Identifier

18441534

Citation

Gomella LG. Re: identification of patients with prostate cancer who benefit from immediate postoperative radiotherapy: EORTC 22911. Eur Urol. 2008 Apr;53(4):855-6. doi: 10.1016/j.eururo.2008.01.039.

Results Reference

background

PubMed Identifier

18365318

Citation

Graefen M. Words of wisdom. Re: Identification of patients with prostate cancer who benefit from immediate postoperative radiotherapy: EORTC 22911. Eur Urol. 2008 Mar;53(3):664-5. doi: 10.1016/j.eururo.2007.12.018. No abstract available.

Results Reference

background

Citation

Bolla M, Van Poppel H, Van Cangh P, et al.: Does post-operative radiotherapy (P-RXT) after radical prostatectomy (Px) improve progression-free survival (PFS) in pT3N0 prostate cancer (PC)? (EORTC 22911). [Abstract] J Clin Oncol 22 (Suppl 14): A-4504, 383, 2004.

Results Reference

result

Citation

Bolla M, Van Poppel H, Van Cangh P, et al.: Post-operative radiotherapy (P-RXT) after radical prostatectomy (Px) improves progression-free survival (PFS) in pT3NO prostate cancer (PC) (EORTC 22911). [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1): A-93, S186, 2004. Available online. Last accessed January 27, 2005.

Results Reference

result

PubMed Identifier

16099293

Citation

Bolla M, van Poppel H, Collette L, van Cangh P, Vekemans K, Da Pozzo L, de Reijke TM, Verbaeys A, Bosset JF, van Velthoven R, Marechal JM, Scalliet P, Haustermans K, Pierart M; European Organization for Research and Treatment of Cancer. Postoperative radiotherapy after radical prostatectomy: a randomised controlled trial (EORTC trial 22911). Lancet. 2005 Aug 13-19;366(9485):572-8. doi: 10.1016/S0140-6736(05)67101-2.

Results Reference

result

PubMed Identifier

12208577

Citation

Davis JB, Reiner B, Dusserre A, Giraud JY, Bolla M; EORTC. Quality assurance of the EORTC trial 22911. A phase III study of post-operative external radiotherapy in pathological stage T3N0 prostatic carcinoma: the dummy run. Radiother Oncol. 2002 Jul;64(1):65-73. doi: 10.1016/s0167-8140(02)00143-3.

Results Reference

result

PubMed Identifier

17931949

Citation

Bolla M, Van Poppel H, Collette L; au nom des groupes genito-urinaire et radiotherapie de l'EORTC. [Preliminary results for EORTC trial 22911: radical prostatectomy followed by postoperative radiotherapy in prostate cancers with a high risk of progression]. Cancer Radiother. 2007 Nov;11(6-7):363-9. doi: 10.1016/j.canrad.2007.09.001. Epub 2007 Oct 10. French.

Results Reference

result

PubMed Identifier

17878474

Citation

Van der Kwast TH, Bolla M, Van Poppel H, Van Cangh P, Vekemans K, Da Pozzo L, Bosset JF, Kurth KH, Schroder FH, Collette L; EORTC 22911. Identification of patients with prostate cancer who benefit from immediate postoperative radiotherapy: EORTC 22911. J Clin Oncol. 2007 Sep 20;25(27):4178-86. doi: 10.1200/JCO.2006.10.4067.

Results Reference

result

Citation

Tombal B, Scaillet P, Opsomer R, et al.: Immediate external beam radiation therapy (EBRT) after radical prostatectomy (PCa): long-term influence on QOL, urinary and rectal symptoms. [Abstract] American Urological Association: Annual Meeting, May 20-25, 2006, Atlanta, GA A-1599, 2006.

Results Reference

result

Citation

van der Kwast TH, Bolla M, van Poppel H, et al.: Gleason Score and margin status are the strongest predictors for benefit of radiotherapy after radical prostatectomy. [Abstract] American Urological Association: Annual Meeting, May 20-25, 2006, Atlanta, GA A-1391, 2006.

Results Reference

result

PubMed Identifier

16941153

Citation

van der Kwast TH, Collette L, Van Poppel H, Van Cangh P, Vekemans K, DaPozzo L, Bosset JF, Kurth KH, Schroder FH, Bolla M; European Organisation for Research and Treatment of Cancer Radiotherapy and Genito-Urinary Cancer Groups. Impact of pathology review of stage and margin status of radical prostatectomy specimens (EORTC trial 22911). Virchows Arch. 2006 Oct;449(4):428-34. doi: 10.1007/s00428-006-0254-x. Epub 2006 Aug 29.

Results Reference

result

PubMed Identifier

16223581

Citation

Collette L, van Poppel H, Bolla M, van Cangh P, Vekemans K, Da Pozzo L, de Reijke TM, Verbaeys A, Bosset JF, Pierart M; European Organisation for Research and Treatment of Cancer (EORTC) Radiotherapy and Genito-urinary Groups. Patients at high risk of progression after radical prostatectomy: do they all benefit from immediate post-operative irradiation? (EORTC trial 22911). Eur J Cancer. 2005 Nov;41(17):2662-72. doi: 10.1016/j.ejca.2005.06.024. Epub 2005 Oct 11.

Results Reference

result

PubMed Identifier

24679462

Citation

Ritter MA. Commentary on "Postoperative radiotherapy after radical prostatectomy for high-risk prostate cancer: long-term results of a randomised controlled trial (EORTC trial 22911)." Bolla M, van Poppel H, Tombal B, Vekemans K, Da Pozzo L, de Reijke TM, Verbaeys A, Bosset JF, van Velthoven R, Colombel M, van de Beek C, Verhagen P, van den Bergh A, Sternberg C, Gasser T, van Tienhoven G, Scalliet P, Haustermans K, Collette L; European Organisation for Research and Treatment of Cancer, Radiation Oncology and Genito-Urinary Groups. Department of Radiation Oncology, Centre Hospitalier Universitaire A Michallon, Grenoble, France.: Lancet 2012;380(9858):2018-27. doi: 10.1016/S0140-6736(12)61253-7. [Epub 2012 Oct 19]. Urol Oncol. 2014 Apr;32(3):372-3. doi: 10.1016/j.urolonc.2013.09.023.

Results Reference

derived

PubMed Identifier

23084481

Citation

Bolla M, van Poppel H, Tombal B, Vekemans K, Da Pozzo L, de Reijke TM, Verbaeys A, Bosset JF, van Velthoven R, Colombel M, van de Beek C, Verhagen P, van den Bergh A, Sternberg C, Gasser T, van Tienhoven G, Scalliet P, Haustermans K, Collette L; European Organisation for Research and Treatment of Cancer, Radiation Oncology and Genito-Urinary Groups. Postoperative radiotherapy after radical prostatectomy for high-risk prostate cancer: long-term results of a randomised controlled trial (EORTC trial 22911). Lancet. 2012 Dec 8;380(9858):2018-27. doi: 10.1016/S0140-6736(12)61253-7. Epub 2012 Oct 19.

Results Reference

derived

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Radiation Therapy Compared With No Further Treatment Following Surgery in Treating Patients With Prostate Cancer

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