- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00255814
Radiation Therapy in Treating Patients With Liver Metastases
A Phase I Trial of Highly Conformal Radiation Therapy for Patients With Liver Metastases
RATIONALE: 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 radiation therapy in treating patients with liver metastases.
Studieoversikt
Detaljert beskrivelse
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of high dose per fraction, highly conformal radiotherapy in patients with liver metastases.
Secondary
- Determine the failure patterns and survival of patients treated with this regimen.
- Correlate dose-volume characteristics with possible toxic effects of this regimen in these patients.
- Determine the local control rate within irradiated fields in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study.
Patients undergo highly conformal radiotherapy (HCR) to the liver once daily, 5 days a week, for 2 weeks.
Cohorts of 6 patients receive escalating doses of HCR until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed periodically for 3 years.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
-
-
Quebec
-
Montreal, Quebec, Canada, H2W 1S6
- McGill Cancer Centre at McGill University
-
-
-
-
New York
-
Rochester, New York, Forente stater, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
- Histologically confirmed non-lymphoma liver metastases
- New radiographic liver lesions most consistent with metastases in a patient with known, histologically proven non-lymphoma cancer AND a previously negative CT scan, MRI, or PET/CT scan of the liver
- No more than 5 measurable lesions by contrast-enhanced liver CT scan, MRI, or PET/CT scan
- Liver metastases ≤ 8 cm
- Medically unfit for surgery OR lesions are surgically unresectable
- All intrahepatic disease must be encompassed within the study radiation field
- Extrahepatic disease outside the liver is allowed provided the hepatic disease is life-limiting
- At least 1,000 cc of normal liver
- No clinical ascites
- No CNS metastases
PATIENT CHARACTERISTICS:
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,800/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 8 g/dL (transfusion allowed)
Hepatic
- No active hepatitis
- No clinically significant liver failure
- No underlying cirrhosis
Renal
- Not specified
Cardiovascular
- No congestive heart failure requiring hospitalization within the past 6 months
- No unstable angina pectoris requiring hospitalization within the past 6 months
- No transmural myocardial infarction within the past 6 months
Pulmonary
- No chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the breast, oral cavity, cervix or primary liver metastasis
- No acute bacterial or fungal infection requiring IV antibiotics
PRIOR CONCURRENT THERAPY:
Chemotherapy
- At least 4 weeks since prior chemotherapy
- No concurrent chemotherapy
- No anthracyclines within 4 weeks after completion of study therapy (1 week for other chemotherapy)
Radiotherapy
- No prior radiotherapy to the region of study
- No concurrent intensity-modulated radiotherapy
Surgery
- Prior liver resection or ablative therapy allowed
Other
- No concurrent warfarin or IV heparin
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: Radiation therapy dose level II: 4.0 Gy/fx
Radiation therapy dose level II: 4.0 Gy/fraction
|
|
Annen: Radiation therapy dose level III: 4.5 Gy/fx
Radiation therapy dose level III: 4.5 Gy/fraction
|
|
Annen: Radiation therapy dose level IV: 5.0 Gy/fx
Radiation therapy dose level IV: 5.0 Gy/fraction
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
To determine the maximally tolerated dose
Tidsramme: From start of treatment to 90 days
|
From start of treatment to 90 days
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Alan W. Katz, MD, James P. Wilmot Cancer Center
- Studiestol: Laura A. Dawson, MD, Princess Margaret Hospital, Canada
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
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
- RTOG-0438
- CDR0000450766
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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