Radiation Therapy After Prostatectomy in Treating Patients With Stage III Prostate Cancer
Phase III Randomized Evaluation of Adjuvant Radiotherapy vs No Adjuvant Therapy Following Radical Prostatectomy and Pelvic Lymphadenectomy in Surgical Stage C Adenocarcinoma of the Prostate
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
OBJECTIVES:
I. Compare disease-free survival rates of patients randomly assigned to adjuvant external-beam radiotherapy vs. no adjuvant therapy following radical prostatectomy and pelvic lymphadenectomy for surgical Stage C (T3 N0 M0) adenocarcinoma of the prostate.
II. Determine the qualitative and quantitative toxicities associated with this adjuvant therapy.
OUTLINE: Randomized study. Randomization takes place when the patient is physically able to begin treatment, any time within 16 weeks after surgery.
Arm I: Radiotherapy. Irradiation of the prostatic bed using megavoltage equipment with effective photon energies of greater than 4 MV.
Arm II: No further treatment.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 3
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Pathologically documented Stage C (T3 N0 M0) adenocarcinoma of the prostate following radical prostatectomy and pelvic lymphadenectomy for clinical Stage A/B disease
- Ineligible for SWOG protocols of higher priority
At least 1 of the following on pathologic examination:
- Presence of cancer in the seminal vesicles
- Evidence of cancer at the inked surgical margin of the prostate
- Extension of tumor beyond the prostatic capsule
Negative preoperative metastatic survey within 6 months prior to registration, including the following:
- Normal bone scan
- No palpable evidence of extraprostatic tumor extension
- Bilateral lymph node dissection histologically negative for cancer
Nodal sampling not required with the following stage/biopsy specimen Gleason score/preoperative PSA:
- Stage T1a/2-6/<10 ng/ml
- Stage T1b-c/2-5/<10 ng/ml
- Stage T2a/2-6/<10 ng/ml
- Stage T2b/2-6/<6 ng/ml
- Stage T2c/2-6/<4 ng/ml
Free from the following postoperative complications:
- Total urinary incontinence
- Intraoperative rectal injury
- persistent urinary extravasation
- Pelvic infection
- Concurrent registration on protocol SWOG-9205 (serum repository protocol) optional
- Concurrent registration on protocol SWOG-8994 (quality-of-life study) required of English-speaking and Spanish-speaking patients enrolled by SWOG
--Patient Characteristics--
- Age: Any age
- Performance status: SWOG 0-2
- Life expectancy: At least 2 years
Hematopoietic:
- WBC at least institutional LLN
- Platelets at least institutional LLN
- Hepatic: SGOT no more than 2 x ULN
- Other: No second malignancy within 5 years except adequately treated nonmelanomatous skin cancer
--Prior Concurrent Therapy--
- Chemotherapy: No prior chemotherapy for prostate cancer
- Endocrine therapy: No more than 3 months of hormonal therapy prior to prostatectomy allowed
- Radiotherapy: No prior radiotherapy for prostate cancer
- Surgery: Radical prostatectomy and pelvic lymphadenectomy within 16 weeks prior to registration required
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Arm I
Radiotherapy.
Irradiation of the prostatic bed using megavoltage equipment with effective photon energies of greater than 4 MV.
|
|
|
Kein Eingriff: Arm II
No further treatment.
|
Mitarbeiter und Ermittler
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Thompson IM, Paradelo JC, Crawford ED, Coltman CA, Blumenstein B. An opportunity to determine optimal treatment of pT3 prostate cancer: the window may be closing. Urology. 1994 Dec;44(6):804-11. doi: 10.1016/s0090-4295(94)80161-4. No abstract available.
- Swanson GP, Thompson IM, Tangem C, et al.: Phase III randomized study of adjuvant radiation therapy versus observation in patients with pathologic T3 prostate cancer (SWOG 8794). [Abstract] Int J Radiat Oncol Biol Phys 63 (Suppl 1): A-1, S1, 2005.
- Thompson IM Jr, Tangen CM, Paradelo J, Lucia MS, Miller G, Troyer D, Messing E, Forman J, Chin J, Swanson G, Canby-Hagino E, Crawford ED. Adjuvant radiotherapy for pathologically advanced prostate cancer: a randomized clinical trial. JAMA. 2006 Nov 15;296(19):2329-35. doi: 10.1001/jama.296.19.2329.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- NCI-2012-02483
- SWOG-8794
- CAN-NCIC-PR2
- CLB-9493
- EST-9887
- NCCTG-895251
- RTOG-9019
- INT-0086
- CDR0000075112 (Registrierungskennung: PDQ (Physician Data Query))
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