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Efficacy Study of Adding Chemotherapy to Radiotherapy for Treating Bladder Cancer.

10 luglio 2017 aggiornato da: Trans Tasman Radiation Oncology Group

A Randomised Trial of Radical Chemo/Radiotherapy vs Radiotherapy Alone in the Definitive Management of Localised Muscle Invasive TCC of the Urinary Bladder

The purpose of this study is to define the optimal management of localised transitional cell carcinoma (TCC) of the urinary bladder. The main objective is to evaluate whether chemoradiation is superior to radiotherapy alone.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Whilst concurrent chemo-radiation is increasingly being looked upon as the treatment of choice for patients referred for bladder preservation, the study by the NCI of Canada (Coppin CM, Gospodarowicz MK et al.Improved Local Control of Invasive Bladder Cancer by Concurrent Cisplatin and Pre-operative or Definitive Radiation.J. of Clinical Oncol. 14(11): 2901-2907, 1996) is the only randomised trial to show some superiority of concurrent Cisplatin and radiation treatment over radiation alone in increasing pelvic tumour control. There was no impact on overall survival. However, this study had relatively small subject numbers and included two distinct treatment options. In one group the patients were treated with a bladder sparing approach and in the other by pre-operative therapy and cystectomy with the type of definitive treatment being decided upon by both the treating Specialist and patient. At 5 years the pelvic failure rates in the radiation alone and chemo-radiation arms were 59% and 40% respectively. With half of the patients in each group having had planned cystectomy as part of their treatment regimen, the above rates of local relapse (especially in the chemo-radiation arm) are disappointing.

Given the concerns with the above study, and the continuing paucity of randomised phase III studies comparing chemo-radiation with radiation alone, there lies an opportunity for Australasian centres to take up the challenge. For this study, the proposed schedule for the chemo-radiation arm is to be the same as that being investigated in our previous phase II study (six weekly doses of Cisplatin plus radiation to a dose of 64Gy in 32 fractions over 6.5 weeks). This will be compared with radical radiation alone (64Gy in 32 fractions over 6.5 weeks).

Tipo di studio

Interventistico

Iscrizione (Effettivo)

67

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 1871
        • Liverpool Hospital
      • Newcastle, New South Wales, Australia, 2298
        • Calvary Mater Newcastle
      • Penrith, New South Wales, Australia, 2751
        • Nepean Cancer Care Centre
      • Randwick, New South Wales, Australia, 2031
        • Prince of Wales Hospital
      • Wentworthville, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4120
        • Mater Centre - South Brisbane
      • Douglas, Queensland, Australia, 4814
        • Townsville Hospital
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane Hospital
      • Tugun, Queensland, Australia, 4224
        • East Coast Cancer Centre
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Tasmania
      • Launceston, Tasmania, Australia, 7250
        • Launceston General Hospital
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Peter MacCallum Cancer Centre
      • Geelong, Victoria, Australia, 3220
        • Andrew Love Cancer Care Centre, Geelong Hospital
      • Prahran, Victoria, Australia, 3181
        • Alfred Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital
  • Nuova Zelanda
      • Auckland, Nuova Zelanda, 1001
        • Auckland Hospital
      • Christchurch, Nuova Zelanda, 4710
        • Christchurch Hospital
      • Dunedin, Nuova Zelanda
        • Dunedin Hospital
      • Palmerston North, Nuova Zelanda
        • Palmerston North Hospital
      • Wellington, Nuova Zelanda, 7902
        • Wellington Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Histologically proven TCC of the urinary bladder. Mixed tumours comprising predominantly TCC and elements of squamous or adenomatous metaplasia or carcinoma are also eligible.
  • Clinically and radiologically localised T2, T3 or T4a non-bulky disease (<= 7cm in maximum dimension), N0, M0.

If radiological evaluation of a lymph node is interpreted as "positive" this must be evaluated further by either lymph node sampling or percutaneous needle biopsy. Patients with histologically confirmed lymph node metastases will not be eligible.

  • Maximal TUR.

N.B. Previous:

  1. partial cystectomy;
  2. endoscopic resection of bladder tumour/s;
  3. intravesical chemotherapy; or
  4. intravesical BCG

does not exclude the patient from being eligible. However, the patient should have an adequate functioning bladder (this should be clarified with the referring Urologist and if need be voiding volumes should be measured).

  • Creatinine clearance >= 50ml/minute by calculation or measurement.
  • A white blood cell count >= 3.5 x 10^9/L with an absolute neutrophil count >= 1.5 x 10^9/L and a platelet count >= 100 x 10^9/L.
  • ECOG status of 0, 1 or 2.
  • No age limit applies provided the patient is mentally, physically and geographically capable of undergoing treatment and follow-up.
  • No significant intercurrent morbidity.

Exclusion Criteria:

  • Pure squamous carcinomas or adenocarcinomas.
  • Extensive or multifocal CIS change in the bladder.
  • T3 or T4a tumours unsuitable for curative treatment (i.e. > 7cm in any dimension), T4b, node positive and metastatic disease.
  • Presence of ureteric obstruction due to tumour infiltration at the UO not amenable to stenting.
  • Previous radiation treatment to the pelvis.
  • Previous significant pelvic surgery.
  • Significant bowel or gynaecological inflammatory disease.
  • Creatinine clearance < 50ml/minute by calculation or measurement. A white blood cell count < 3.5 x 10^9/L with an absolute neutrophil count < 1.5 x 10^9L and/or a platelet count < 100 x 10^9/L.
  • Other considerations making patient unfit for Cisplatin therapy.

  • Prior or concurrent malignancy of any other site unless disease-free for greater than 5 years, except for:

    1. non-melanoma skin cancer, and/or
    2. (a) Stage T1 well differentiated prostatic carcinoma in men, and In situ carcinoma of the cervix in women.
  • Bladder tumour - biopsy only. These patients must be referred back for more adequate resections or else should not be included

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: A
Synchronous chemo / radiation therapy
Droga: Cisplatin
Weekly Cisplatin 35mg/m2 x 6 doses, IV administration
Altri nomi:
  • Cisplatuin Ebewe, Cisplatin Injection
Radiazione: External beam radiation treatment
64Gy reference dose in 32 fractions over 6.5 weeks
Altri nomi:
  • Radiazione
Comparatore attivo: B
Radiation Alone
Radiazione: External beam radiation treatment
64Gy reference dose in 32 fractions over 6.5 weeks
Altri nomi:
  • Radiazione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Invasive local failure at 3 years
Lasso di tempo: 3 years
3 years

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Complete response (CR) rate at 3 months from randomisation
Lasso di tempo: 3 months
3 months
Disease-free survival
Lasso di tempo: Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
Overall survival
Lasso di tempo: Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
Cystectomy-free survival
Lasso di tempo: Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
Acute and late toxicity
Lasso di tempo: Interim analyses will be performed on an annual basis.
Interim analyses will be performed on an annual basis.
Pattern of failure (local, regional, distant)
Lasso di tempo: Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
Quality of life measures
Lasso di tempo: Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Trans Tasman Radiation Oncology Group

Collaboratori

National Health and Medical Research Council, Australia

Investigatori

  • Cattedra di studio: Kumar Gogna, Mater Centre - South Brisbane

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2002

Completamento primario (Effettivo)

1 febbraio 2010

Completamento dello studio (Effettivo)

1 febbraio 2010

Date di iscrizione allo studio

Primo inviato

25 maggio 2006

Primo inviato che soddisfa i criteri di controllo qualità

25 maggio 2006

Primo Inserito (Stima)

26 maggio 2006

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 luglio 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 luglio 2017

Ultimo verificato

1 luglio 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • TROG 02.03
  • NHMRC 243100

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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