- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01892930
Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Kidney Cancer Undergoing Surgery
Immunologic Impact of Stereotactic Body Radiation Therapy (SBRT) in Renal Cell Carcinoma
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
PRIMARY OBJECTIVES:
I. Assess the impact of stereotactic body radiation therapy (SBRT) on the immune system in patients with metastatic renal cell carcinoma (RCC).
SECONDARY OBJECTIVES:
I. Assess changes in immune parameters prior to radiation, post radiation and post nephrectomy.
TERTIARY OBJECTIVES:
I. Assess surgical parameters for partial or radical nephrectomy post SBRT.
OUTLINE:
Patients undergo SBRT on day 1 and undergo partial or radical nephrectomy on day 29.
After completion of study treatment, patients are followed up at 30 days.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
New York
-
Buffalo, New York, Förenta staterna, 14263
- Roswell Park Cancer Institute
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Have metastatic RCC with primary tumor in place
- Must be surgical candidates as deemed fit by surgeon
- Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present
- Patients of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Radiation to primary tumor prior to enrollment in this study
- Pregnant or nursing female patients
- Unwilling or unable to follow protocol requirements
- Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive treatment
- Received an investigational agent within 30 days prior to enrollment
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Treatment (SBRT, nephrectomy)
Patients undergo SBRT on day 1 and undergo partial or radical nephrectomy on day 29.
|
Korrelativa studier
Genomgå SBRT
Andra namn:
Undergo partial or radical nephrectomy
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Feasibility of conducting a partial nephrectomy in patients with no prior stereotactic radiation for kidney cancer
Tidsram: Up to 30 days post-treatment
|
Up to 30 days post-treatment
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Toxicity analysis assessed by the CTEP Version 4 of the NCI Common Terminology Criteria for Adverse Events (CTCAE)
Tidsram: Up to 30 days post-treatment
|
Up to 30 days post-treatment
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Thomas Schwaab, Roswell Park Cancer Institute
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- I 212712
- NCI-2013-01201 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
Läkemedels- och apparatinformation, studiedokument
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