Intensity Modulated Radiotherapy for Breast Cancer (IMRT)
8 agosto 2017 aggiornato da: Washington University School of Medicine
Intensity Modulated Radiation Therapy for Breast Cancer: A Phase I Feasibility Study
This study delivers radiation therapy to any residual breast tissue and the chest wall plus lymph node areas around the breast.
These lymph node areas are under the arm, around the collar bone, and under the sternum (breastbone).
Panoramica dello studio
Descrizione dettagliata
IMRT treatment uses a computer-controlled x-ray (CT) to deliver radiation beams at several different angles and strengths to deliver precise doses to the regions at risk for recurrence of breast cancer while reducing or sparing the dose to critical structures (heart, lungs) and nearby normal tissue.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
100
Fase
- Fase 1
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
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Missouri
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Saint Louis, Missouri, Stati Uniti, 63110
- Washington University School of Medicine
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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
Femmina
Descrizione
Inclusion Criteria:
- Female gender
- Age ≥ 18 years
- Invasive primary female breast cancer
- Pathologically proven regional nodal metastasis
- Status post mastectomy or partial mastectomy with an assessment of axillary nodes via sentinel lymph node biopsy and/or axillary lymph node dissection.
- Signed study specific consent form
Exclusion Criteria:
- Distant metastasis
- Currently Pregnant
- Psychiatric or addictive disorders that preclude informed consent
- Time from initial diagnosis to the start of radiation therapy > one year
- Estimated life expectancy judged to be < one year
- Prior radiation to the ipsilateral breast or chest wall
- Primary breast cancer is lymphoma or sarcoma
- Patients being treated with concurrent chemotherapy.
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: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: IMRT
The prescribed dose for all patients will be 5040 cGy in 28 fractions.
Patients will receive external beam treatment once a day, five days a week for approximately five and a half weeks.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Evaluate the feasibility of adjuvant comprehensive radiation therapy via IMRT with daily set-up position verified using 3D verification
Lasso di tempo: Within 1 year of protocol registration
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The study will be deemed infeasible if greater than 10% of enrolled patients have at least one of the following outcomes:
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Within 1 year of protocol registration
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Evaluate the rate and severity of both acute and late cutaneous toxicity
Lasso di tempo: 6-8 months following completion of treatment and 12-14 months following completion of treatment
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6-8 months following completion of treatment and 12-14 months following completion of treatment
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Evaluate the rate and severity of late subcutaneous fibrosis
Lasso di tempo: 6-8 months following completion of treatment and 12-14 months following completion of treatment
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6-8 months following completion of treatment and 12-14 months following completion of treatment
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Evaluate the rate of radiation pneumonitis
Lasso di tempo: 6-8 weeks following completion of treatment, 3-4 months following completion of treatment, 6-8 months following completion of treatment, and 12-14 months following completion of treatment
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6-8 weeks following completion of treatment, 3-4 months following completion of treatment, 6-8 months following completion of treatment, and 12-14 months following completion of treatment
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Evaluate ipsilateral upper quadrant function
Lasso di tempo: Pretreatment and 3-4 months following completion of treatment
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For patients who receive physical therapy, objective measures of the rotator cuff, bursa, and joint space will be evaluated by diagnostic ultrasound if medically indicated.
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Pretreatment and 3-4 months following completion of treatment
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Evaluate patient quality of life
Lasso di tempo: Pretreatment, 6-8 months following completion of treatment, and 12-14 months following completion of treatment
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Pretreatment, 6-8 months following completion of treatment, and 12-14 months following completion of treatment
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Evaluate local-regional control rates
Lasso di tempo: 12-14 months following completion of radiation therapy
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12-14 months following completion of radiation therapy
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Evaluate patient set-up reproducibility in breast cancer patients treated with IMRT using daily 3D position verification
Lasso di tempo: 12-14 months following completion of treatment
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12-14 months following completion of treatment
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Imran Zoberi, MD, Washington University School of Medicine
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.
Pubblicazioni generali
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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 (Effettivo)
4 gennaio 2008
Completamento primario (Effettivo)
8 agosto 2016
Completamento dello studio (Effettivo)
8 agosto 2016
Date di iscrizione allo studio
Primo inviato
4 gennaio 2008
Primo inviato che soddisfa i criteri di controllo qualità
14 gennaio 2008
Primo Inserito (Stima)
15 gennaio 2008
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
10 agosto 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
8 agosto 2017
Ultimo verificato
1 agosto 2017
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 07-1077 / 201106403
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Sì
prodotto fabbricato ed esportato dagli Stati Uniti
No
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 .