- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01124682
3-Dimensional Conformal Radiation Therapy in Treating Patients With Bladder Cancer Who Have Undergone Transurethral Resection of the Bladder
Image Guided Dose Escalated Adaptive Bladder Radiotherapy
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the side effects and best dose of 3-dimensional conformal radiation therapy in treating patients with bladder cancer who have undergone transurethral resection of the bladder.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
- Fremgangsmåte: diffusjonsvektet magnetisk resonansavbildning
- Fremgangsmåte: livskvalitetsvurdering
- Stråling: 3-dimensjonal konform strålebehandling
- Fremgangsmåte: diagnostic cystoscopy
- Fremgangsmåte: implanted fiducial-based imaging
- Stråling: bildeveiledet strålebehandling
- Stråling: selektiv ekstern strålebehandling
Detaljert beskrivelse
OBJECTIVES:
Primary
- To determine the maximum-tolerated dose of external-beam radiotherapy delivered as a tumor boost in patients who have undergone prior transurethral bladder resection for muscle-invasive carcinoma of the bladder.
Secondary
- To document progression-free survival and overall survival of these patients.
- To evaluate patterns of recurrence and bladder preservation rates following dose-escalated radiotherapy in these patients.
- To determine the impact of acute and late toxicity on quality of life in these patients.
- To assess the use of gold seeds for tumor boost delineation in these patients.
- To evaluate the use of virtual cystoscopy tumor localization in these patients.
- To assess coverage of the phase II radiotherapy boost volume on the daily cone-beam images.
- To assess coverage of the phase III radiotherapy volume on cone-beam images with selected adaptive strategy.
- To evaluate the use of diffusion-weighted MRI (dwMRI) scans in assessing response to radiotherapy.
OUTLINE: This is a dose-escalation study.
Patients undergo a rigid cystoscopy and gold-seed insertion, if clinically appropriate. Approximately 3-5 seeds are inserted into the bladder wall to demarcate the maximum extent of visible tumor or tumor bed via a customized introducer. All patients undergo 3-dimensional conformal radiotherapy once daily, 5 days per week during weeks 1 and 4-7 and once daily, 4-6 days per week during weeks 2 and 3, using a combination of image-guided radiotherapy techniques and a partial bladder radiotherapy boost.
Patients complete quality-of-life questionnaire QOL-30 at baseline, 1 and 3 months, and then annually after completion of study treatment.
After completion of study treatment, patients are followed up at 4, 8, and 12 weeks, every 6 months for 3 years, and then annually for 2 years.
Studietype
Registrering (Forventet)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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England
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Sutton, England, Storbritannia, SM2 5PT
- Rekruttering
- Royal Marsden - Surrey
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Ta kontakt med:
- Contact Person
- Telefonnummer: 44-20-8661-3457
- E-post: robert.huddart@icr.ac.uk
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
Histologically confirmed invasive bladder carcinoma, including the following cellular types:
- Adenocarcinoma
- Transitional cell carcinoma
- Squamous cell carcinoma
Clinical stage G1-3, pT2a-4 disease
- Localized disease
- No bone or visceral metastases
- No lymph node metastases
- Has undergone maximal transurethral resection of the bladder tumor and planning to receive radical radiotherapy
PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Hemoglobin > 10 g/dL
- WBC > 3,000/mm^3
- Platelet count > 150,000/mm^3
- Creatinine < 120 μmol/L
- Bilirubin < 1.5 times upper limit normal (ULN)
- AST < 1.5 times ULN
- Alkaline phosphatase < 1.5 times ULN
- Not pregnant
- No inflammatory bowel disease or other significant small bowel disease
- Physically fit for radical radiotherapy
- No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
No other malignancy within the past 2 years except adequately treated basal cell carcinoma of the skin or adequately treated carcinoma in situ of the cervix uteri
- Prior superficial transitional cell carcinoma of the bladder allowed
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior pelvic surgery
- No bilateral hip replacements compromising accurate radiotherapy planning
- No prior radiotherapy to the pelvis
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
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Maksimal tolerert dose
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Sekundære resultatmål
Resultatmål |
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Progresjonsfri overlevelse
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Total overlevelse
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Livskvalitet
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Bladder preservation rates
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Acute and late toxicity and safety profile
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Tumor boost volumes delineated with and without gold seeds
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Dose-volume histogram analysis of PTV2 and PTV3 coverage
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Change in diffusion coefficient between pre- and post-radiotherapy dwMRI scans
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Robert A. Huddart, MD, Royal Marsden NHS Foundation Trust
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CDR0000671670
- ICR-IDEAL
- EU-21035
- CCR-3217
- MREC-09/H0801/40
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