Stereotactic Body Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer

Titre officiel

Seamless Phase I/II Study of Stereotactic Lung Radiation Therapy (SBRT) for Early Stage, Centrally Located, Non-Small Cell Lung Cancer (NSCLC) in Medically Inoperable Patients

Sommaire:

JUSTIFICATION : La radiothérapie stéréotaxique corporelle pourrait permettre de délivrer une dose de rayonnement directement à la tumeur et moins léser les tissus normaux.

BUT : Cet essai de phases I et II vise à déterminer la meilleure dose de radiothérapie stéréotaxique corporelle et à évaluer les effets secondaires et l’efficacité de ce traitement chez les patients atteints d’un cancer du poumon non à petites cellules de stade I.

Description de l'essai

Primary Outcome:

• Maximum tolerated dose of stereotactic body radiation therapy (SBRT) as assessed by NCI CTCAE v4.0 (Phase I)
• Dose-limiting toxicity (DLT) of ≥ grade 3 as assessed by NCI CTCAE v4.0 (Phase I)

Secondary Outcome:

• 2-year local control rate (Phase II)
• Progression-free survival
• Overall survival
• Time to local progression
• Time to regional nodal progression
• Time to distant metastases
• Toxicity (other than DLT) of ≥ grade 3 as assessed by NCI CTCAE v4.0
• Late toxicity (i.e., occurs > 1 year after the start of SBRT) of ≥ grade 3 as assessed by NCI CTCAE v4.0

OBJECTIVES:
Primary

• To determine the maximum tolerated dose (MTD) of stereotactic body radiation therapy (SBRT) in medically inoperable patients with centrally located stage I non-small cell lung cancer. (Phase I)

• To determine the efficacy of SBRT when administered at the MTD in these patients. (Phase I)

• To estimate the local control rate of SBRT at the MTD in these patients. (Phase II)
  

Secondary

• To estimate the rates of adverse events (other than dose-limiting toxicity) of ≥ grade 3 that is possibly, probably, or definitely related to treatment and that occurs within 1 year after the start of SBRT in these patients.

• To estimate the rates of late adverse events (i.e., occurs > 1 year after the start of SBRT) in these patients.

• To estimate the local control and progression-free and overall survival rates in patients treated with this regimen.

OUTLINE:

This is a multicentre study. Patients undergo stereotactic body radiation therapy every 2 days over 1½-2 weeks (total of 5 fractions) in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed periodically.

Voir cet essai sur ClinicalTrials.gov