En fase I/II-studie av hypofraksjonert protonterapi for stadium II-III ikke-småcellet lungekreft
The purpose of this research study is to compare the effects (good and bad) on subjects and their cancer using standard chemotherapy in combination with hypofractionated proton radiation therapy. Hypofractionation is a technique that delivers higher daily doses of radiation over a shorter period of time.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Conventional fractionated photon-based radiotherapy to 60-63 Gy at 1.8-2 Gy/fraction with concurrent chemotherapy remains the standard treatment practice in patients with stage III non-small cell lung carcinoma (NSCLC) with local control rates of approximately 50% and a median overall survival of just 18 months.Unfortunately, even the standard treatment has significant toxicity with approximately 40% of patients developing grade 3 or higher acute toxicities in the RTOG 9410 study.1 These outcomes are poor and more effective treatment regimens are needed.
Higher doses of radiation have been hypothesized to improve local control in patients with stage III NSCLC. This is expected to translate into better overall survival.Given the significant improvements in outcome in patients receiving hypofractionation for stage I NSCLC, perhaps similar gains could be achieved if hypofractionated radiotherapy could be safely delivered to stage II-III NSCLC with concurrent chemotherapy. Hypofractionated radiotherapy may offer improvement in local control compared with conventional fractionation that may translate into improved overall survival. Furthermore, hypofractionation will shorten the time interval during which patients are receiving less aggressive chemotherapy. Proton therapy is a highly conformal radiotherapy technique that takes advantage of the proton's characteristic Bragg Peak, resulting in significant reductions in the exit dose of the treatment beam. Thus, proton therapy can substantially reduce the dose to critical structures even compared with IMRT.
This study will investigate the safety and efficacy of delivering hypofractionated proton therapy with concurrent chemotherapy in patients with stage II-III NSCLC
Studietype
Registrering (Faktiske)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiesteder
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Florida
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Jacksonville, Florida, Forente stater, 32206
- University of Florida Proton Therapy Institute
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Illinois
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Warrenville, Illinois, Forente stater, 60555
- Northwestern Medicine Chicago Proton Center
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Maryland
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Baltimore, Maryland, Forente stater, 21201
- Maryland Proton Treatment Center
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New Jersey
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Somerset, New Jersey, Forente stater, 08873
- Princeton ProCure Management LLC
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73142
- Oklahoma Proton Center
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Virginia
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Hampton, Virginia, Forente stater, 23666
- Hampton University Proton Therapy Institute
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
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Pathologically confirmed invasive non-small cell lung cancer within 12 weeks prior to study registration. OR Pathologically confirmed invasive non-small cell lung cancer within 6 months prior to study registration if the patient received induction chemotherapy.
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AJCC (American Joint Committee on Cancer) 7th Ed. clinical stage II-III.
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ECOG Performance status 0-1 within 8 weeks prior to study registration.
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Patient must give study-specific informed consent on an IRB-approved consent prior to any research-related procedures or study treatment.
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Patient must be at least 18 years old at the time of consent.
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Patient must complete all required tests in section 4.
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Lab results per the following within 4 weeks prior to study registration:
- Absolute neutrophil count (ANC) >1,800 cells/mm3.
- Platelets > = 100,000 cells/mm3.
- Hemoglobin > =10 g/dl. The use of transfusion or other intervention to achieve Hgb ≥10.0 g/dl is acceptable.
- AST/SGOT and ALT/SGPT < 2.5 x the institutional upper limit of normal (IULN).
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Post exploratory thoracotomy must be done > 3 weeks prior to study registration or patient did not have post exploratory thoracotomy.
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PFT (pulmonary function test) with a FEV1 > 0.75 liters/second within 16 weeks prior to study registration.
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Patients must be evaluated by a thoracic surgeon, pulmonologist or medical oncologist and deemed medically or surgically unacceptable for resection.
Exclusion Criteria:
- Evidence of distant metastasis (M1) involvement.
- Prior radiotherapy to thoracic area.
- Unintentional weight loss >10% within 4 weeks prior to study registration.
- Pregnant and/or breast-feeding women, or patients (men and women) of child-producing potential not willing to use medically acceptable forms of contraception while on study treatment and for at least 12 months after study treatment. Pregnancy testing is not necessary for women who have had a hysterectomy or have not had a menstrual period for at least 24 consecutive months.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Protonstrålebehandling med kjemoterapi
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RADIATION: Proton Radiotherapy Dose Level 1: 60 Gy (RBE) at 2.5 Gy(RBE) per fraction x 24 fractions Dose Level 2: 60 Gy (RBE) at 3 Gy (RBE) per fraction x 20 fractions Dose Level 3: 60.01 Gy (RBE) at 3.53 Gy (RBE) per fraction x 17 fractions Dose Level 4: 60 Gy (RBE) at 4 Gy (RBE) per fraction x 15 fractions CONCURRENT CHEMOTHERAPY: Paclitaxel at a dose of 45 mg/m2 and Carboplatin at a dose of AUC 2 mg/min/ml (a total of 3-5 weekly doses) OR Cisplatin 50mg/m2 days 1, 8, 29, and 36 and Etoposide 50mg/m2 days 1-5, 29-33. For non squamous histology, Carboplatin AUC 5 on day 1 and Pemetrexed 500 mg/m2 on day 1 every 21 days OR Cisplatin 75 mg/m2 on day 1 and Pemetrexed 500 mg/m2 on day 1 every 21 days. Adjuvant chemotherapy is optional. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Fase II: Bestem prosentandelen av pasienter som overlever minst 12 måneder
Tidsramme: Ved 12 måneder
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Ved 12 måneder
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Phase I: Establish the maximum tolerated dose of radiotherapy in terms of Gy (RBE)/fraction using hypofractionated proton therapy concurrently with chemotherapy.
Tidsramme: Weekly until completion of radiation treatment
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This phase will have a minimum of 2 treated patients and we anticipate that the MTD will be located before a maximum of 28 patients are treated. The trial begins by treating 5 patients at 2.5 Gy (RBE)/fraction to a dose of 60 Gy (RBE). |
Weekly until completion of radiation treatment
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Vurder akutte og sene bivirkninger ved samtidig kjemoterapi med hypofraksjonert protonterapi.
Tidsramme: I gjennomsnitt hver 3. måned i 5 år
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I gjennomsnitt hver 3. måned i 5 år
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Analyser for sykdomskontroll og total overlevelse.
Tidsramme: Ved 2 år og 5 år
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Ved 2 år og 5 år
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Brad Hoppe, MD, Proton Collaborative Group
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Antatt)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
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
- LUN005-12
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