- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01656460
Stereotactic Body Radiation for Consolidation After Standard Chemoradiation for Stage 3 Lung Cancer
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Rhode Island
-
Pawtucket, Rhode Island, Forenede Stater, 02860
- Memorial Hospital of Rhode Island
-
Providence, Rhode Island, Forenede Stater, 02903
- Rhode Island Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
PATIENT ELIGIBILITY Conditions for Patient Eligibility (Inclusion)
- Pathologically or cytologically confirmed NSCLC
- Stage III NSCLC according to the AJCC 7th edition staging criteria. Stage II (T1-3N1) patient that are deemed medically inoperable are also eligible.
- Concurrent chemoradiation to a radiation dose of 50.4 Gy.
residual tumor volume after concurrent chemoradiation that is appropriate for SBRT:
- Primary tumor <120cc (approximately 6cm diameter).
- Mediastinal/Hilar disease: 1-2 involved regions <60cc (approximately 5cmx3cmx3cm)
- Absolute neutrophil count ≥ 1,000/uL, platelet ≥ 60,000/uL.
- Total bilirubin ≤ 2x upper institutional limit of normal (ULN), and AST or ALT ≤5x ULN.
- ECOG performance status 0 to 2
- Minimum life expectancy of 12 weeks.
- Age older than 18 years.
- Voluntary, signed written informed consent.
- Women of childbearing potential must have a negative pregnancy test
- Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 1 months thereafter.
Conditions for Patient Ineligibility (Exclusion)
- Disease progression during or after standard chemoradiation to 50.4 Gy
- Prior thoracic radiation other than the pre-operative radiation not greater than 50.4
- Metastatic disease
- Uncontrolled severe, intercurrent illness.
- Women who are breast-feeding.
- No chemotherapy within 2 weeks from the first SBRT treatment.
- Concurrent anticancer therapy.
- Prior complete resection of all NSCLC.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Stereotactic radiation Arm 1
Dose Levels/total Dose 1 16 Gy |
Dose Levels Dose per Fraction Total Dose 1 8 Gy 16 Gy |
|
Eksperimentel: Stereotactic radiation Arm 2
2 20 Gy
|
Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy
|
|
Eksperimentel: Stereotactic radiation Arm 3
3 24 Gy
|
Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy
|
|
Eksperimentel: Stereotactic radiation Arm 4
4 28 Gy
|
Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Early and Intermediate Toxicity for Dose Limiting Toxicity
Tidsramme: 3 months
|
Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Serious adverse events will be captured from the time the patient signs consent until 12 weeks after the last SBRT. DLTS: defined in protocol as: Dose limiting toxicities will be defined as grade 3 or greater treatment related pneumonitis, cardiac toxicity, bronchial injury or chest wall pain during or within 4 weeks of completion of SBRT. |
3 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Howard Safran, MD, BrUOG Study Chair
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BrUOG 259
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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