- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00062335
High-Dose 3-Dimensional Conformal Radiation Therapy in Treating Patients With Inoperable Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer
A Phase I Study On The Feasibility Of High Dose Three Dimensional Conformal Radiotherapy In Patients With Inoperable And Locally Advanced Non Small Cell Lung Cancer
RATIONALE: Using computer systems that create a 3-dimensional picture of the tumor to plan treatment may enable doctors to provide more effective radiation therapy that will cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the side effects and best dose of high-dose 3-dimensional conformal radiation therapy in treating patients with inoperable stage I, stage II, or stage IIIA non-small cell lung cancer.
Studieoversikt
Detaljert beskrivelse
OBJECTIVES:
- Determine the optimal dose of high-dose 3-dimensional conformal radiotherapy in patients with inoperable stage I, II, or IIIA non-small cell lung cancer who are treated according to the total lung volume irradiated.
- Determine the feasibility of this regimen, in terms of local control rates and incidence of distant metastases, in these patients.
OUTLINE: This is an open-label, nonrandomized, dose-escalation, multicenter study. Patients are assigned to 1 of 3 strata according to the total lung volume irradiated (less than 25% vs 25-37% vs over 37%).
- Stratum I: Patients undergo high-dose 3-dimensional (3-D) conformal radiotherapy 5 days a week for 6 weeks.
- Stratum II: Patients undergo high-dose 3-D conformal radiotherapy 5 days a week for 5.5-7 weeks.
- Stratum III: Patients undergo high-dose 3-D conformal radiotherapy 5 days a week for 5.5-6.5 weeks.
Cohorts of 6-15 patients in each stratum receive escalating dose intensities of high-dose 3-D conformal radiotherapy (either by increasing the total dose or by shortening treatment time) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6, 2 of 15, or 3 of 30 patients experience dose-limiting toxicity.
Patients are followed at 1 month, at least every 2 months for 1 year, every 3 months for 1 year, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 54-135 patients (18-45 per stratum) will be accrued for this study.
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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Brussels, Belgia, 1000
- Institut Jules Bordet
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Brussels, Belgia, 1090
- Academisch Ziekenhuis der Vrije Universiteit Brussel
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Ghent, Belgia, B-9000
- Akademisch Ziekenhuis Gent
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Montpellier, Frankrike, 34298
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
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Nice, Frankrike, 06189
- Centre Antoine Lacassagne
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Paris, Frankrike, 75248
- Institut Curie - Section Medicale
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Lausanne, Sveits, CH-1011
- Centre Hospitalier Universitaire Vaudois
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer
- Medically inoperable stage I or II disease
Stage III disease eligible provided the following are true:
- No supraclavicular node involvement
- No peripherally located lower lobe tumor AND contralateral upper mediastinal node involvement
- No distant metastasis
- No malignant pleural or pericardial effusion
PATIENT CHARACTERISTICS:
Age
- Not specified
Performance status
- WHO 0-2
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Cardiovascular
- No prior myocardial infarction
- No prior complete bundle branch block
- No other prior cardiovascular disease resulting in New York Heart Association class III or IV heart disease
- No clinically significant cardiac arrhythmias
- No congestive heart failure
Pulmonary
- FEV_1 at least 1.2 L OR
- DLCO at least 60%
Other
- No other prior or concurrent malignancy except cured basal cell skin cancer or carcinoma in situ of the cervix
- No intractable or uncontrolled infection
- No psychological, familial, social, or geographical condition that would preclude study compliance and follow-up
- Able to tolerate a course of radiotherapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- At least 3 weeks since prior chemotherapy
- No prior anthracyclines
- No concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy to the chest area
Surgery
- No prior therapeutic surgery to the chest area
Other
- No other prior therapy to the chest area
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
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Maximum tolerated dose as measured by NCI-CTC v2.0 during treatment and up to 6 months after completion of radiotherapy
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Sekundære resultatmål
Resultatmål |
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Late toxicity measured every 2 months in year 1, then every 3 months in year 2, and then every 6 months thereafter
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Disease progression measured every 2 months in year 1, then every 3 months in year 2, and then every 6 months thereafter
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Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Jacques Bernier, MD, PhD, Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (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
- EORTC-22994
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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