- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00009789
Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer And Lung Dysfunction
Accelerated Conformal Radiotherapy for Stage I Non-Small Cell Lung Cancer in Patients With Pulmonary Dysfunction: A Phase I Study
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: Phase I trial to study the effectiveness of specialized high-dose radiation therapy in treating patients who have stage I non-small cell lung cancer and lung dysfunction.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
OBJECTIVES:
- Determine the maximum tolerated course of accelerated 3-dimensional conformal radiotherapy in patients with stage I non-small cell lung cancer with pulmonary dysfunction.
- Determine the short-term and long-term toxicity of this regimen in these patients.
- Determine local tumor control, failure-free survival, and overall survival in patients treated with this regimen.
- Determine the effect of radiotherapy dose volume relationships and pre-treatment pulmonary function studies on the incidence of pulmonary toxicity in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive accelerated 3-dimensional (3-D) conformal radiotherapy daily 5 days a week for 3.5-6 weeks.
Cohorts of 8 patients receive escalating fractions of accelerated 3-D conformal radiotherapy until the maximum tolerated course is determined. The maximum tolerated course is defined as the course at which no more than 2 patients develop at least grade 3 dose-limiting toxicity and no more than 1 patient develops at least grade 4 dose-limiting toxicity.
Patients are followed at 3 weeks, 6 weeks, 3 months, every 3 months for 2 years, and then every 6 months for 3 years.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
-
-
Florida
-
Fort Lauderdale, Florida, Verenigde Staten, 33308
- Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
-
Hollywood, Florida, Verenigde Staten, 33021
- Memorial Cancer Institute at Memorial Regional Hospital
-
Jupiter, Florida, Verenigde Staten, 33458
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
-
Miami Beach, Florida, Verenigde Staten, 33140
- CCOP - Mount Sinai Medical Center
-
-
Illinois
-
Chicago, Illinois, Verenigde Staten, 60637-1470
- University of Chicago Cancer Research Center
-
-
Minnesota
-
Minneapolis, Minnesota, Verenigde Staten, 55455
- Fairview University Medical Center - University Campus
-
-
Missouri
-
Chesterfield, Missouri, Verenigde Staten, 63017
- Saint Luke's Hospital
-
-
Nebraska
-
Grand Island, Nebraska, Verenigde Staten, 68803
- Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
-
North Platte, Nebraska, Verenigde Staten, 69103
- Great Plains Regional Medical Center
-
Omaha, Nebraska, Verenigde Staten, 68198
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
-
-
New York
-
Buffalo, New York, Verenigde Staten, 14215
- Veterans Affairs Medical Center - Buffalo
-
Oswego, New York, Verenigde Staten, 13126
- Oswego Hospital
-
Syracuse, New York, Verenigde Staten, 13210
- SUNY Upstate Medical University Hospital
-
Syracuse, New York, Verenigde Staten, 13057
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
-
Syracuse, New York, Verenigde Staten, 13203
- St. Joseph's Hospital Health Center - Syracuse
-
-
North Carolina
-
Charlotte, North Carolina, Verenigde Staten, 28203
- Blumenthal Cancer Center at Carolinas Medical Center
-
Goldsboro, North Carolina, Verenigde Staten, 27534
- Wayne Memorial Hospital, Incorporated
-
Winston-Salem, North Carolina, Verenigde Staten, 27157
- Comprehensive Cancer Center at Wake Forest University
-
-
Ohio
-
Columbus, Ohio, Verenigde Staten, 43210
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Verenigde Staten, 15224-1791
- Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed stage I (T1-2, N0) non-small cell lung cancer (NSCLC)
- Squamous cell carcinoma
- Basaloid carcinoma
- Adenocarcinoma
- Bronchoalveolar carcinoma
- Adenosquamous carcinoma
- Large cell carcinoma
- Large cell neuroendocrine carcinoma
- Giant cell carcinoma
- Sarcomatoid carcinoma
- Non-small cell carcinoma not otherwise specified
- Tridimensionally measurable solitary parenchymal lung lesion no greater than 4 cm in diameter by chest CT scan (lung windows)
No metastatic disease or hilar or mediastinal lymphadenopathy
Must have mediastinoscopy* (anterior, cervical, or both) if mediastinal lymph nodes are greater than 1.0 cm in diameter by chest CT scan
- No positive lymph nodes on mediastinoscopy* NOTE: *Patients may have positron-emission tomography in lieu of mediastinoscopy provided there is no fludeoxyglucose F 18 uptake in the mediastinum and hilum
Poor surgical risk, as defined by 1 of the following:
- High risk due to nonpulmonary reasons, such as renal failure, cardiac failure, or hepatic dysfunction and deemed by thoracic surgeon to be unsuitable for lobectomy
Pulmonary dysfunction indicated by one or more of the following:
- FEV_1 less than 40% of predicted
- DLCO less than 50% of predicted
- Oxygen dependent
- Chronic PaCO_2 greater than 45 mm Hg
- VO_2 less than 15 mL/kg/min
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- 0-2
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No weight loss of more than 10% within the past 6 months
- No other active (less than 30% risk of relapse after completion of prior therapy) malignancy except nonmelanoma skin cancer
Chemotherapy:
- No prior chemotherapy for NSCLC
Radiotherapy:
- No prior chest radiotherapy
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Radiotherapy
Patients receive accelerated 3-dimensional (3-D) conformal radiotherapy daily 5 days a week for 3.5-6 weeks. Cohorts of 8 patients receive escalating fractions of accelerated 3-D conformal radiotherapy until the maximum tolerated course is determined. The maximum tolerated course is defined as the course at which no more than 2 patients develop at least grade 3 dose-limiting toxicity and no more than 1 patient develops at least grade 4 dose-limiting toxicity. Patients are followed at 3 weeks, 6 weeks, 3 months, every 3 months for 2 years, and then every 6 months for 3 years. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Algemeen overleven
Tijdsspanne: Tot 5 jaar
|
Tot 5 jaar
|
Foutloos overleven
Tijdsspanne: Tot 5 jaar
|
Tot 5 jaar
|
Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Studie stoel: Jeffrey Bogart, MD, State University of New York - Upstate Medical University
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CALGB-39904
- U10CA076001 (Subsidie/contract van de Amerikaanse NIH)
- CDR0000068409 (Register-ID: NCI Physician Data Query)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Longkanker
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)VoltooidAdenocarcinoom van de dunne darm | Stadium III Adenocarcinoom van de dunne darm AJCC v8 | Stadium IIIA Adenocarcinoom van de dunne darm AJCC v8 | Stadium IIIB dunne darm adenocarcinoom AJCC v8 | Stadium IV Adenocarcinoom van de dunne darm AJCC v8 | Ampulla van Vater Adenocarcinoom | Stadium III... en andere voorwaardenVerenigde Staten
-
University of UtahNational Cancer Institute (NCI)WervingVermoeidheid | Sedentaire levensstijl | Gemetastaseerd prostaatcarcinoom | Stadium IV prostaatkanker AJCC (American Joint Committee on Cancer) v8 | Stadium IVA prostaatkanker AJCC (American Joint Committee on Cancer) v8 | Stadium IVB prostaatkanker AJCC (American Joint Committee on Cancer) v8Verenigde Staten
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...VoltooidBestudeer Chinese vrouwen die zich niet hebben gehouden aan de richtlijnen voor screening op mammografie van de American Cancer SocietyVerenigde Staten
-
BioNTech SESeventh Framework ProgrammeVoltooidBorstkanker (Triple Negative Breast Cancer (TNBC))Zweden, Duitsland
-
Novartis PharmaceuticalsVoltooidGeavanceerde Triple Negative Breast Cancer (TNBC) met hoge TAM'sFrankrijk, Italië, Oostenrijk, Taiwan, Verenigde Staten, Spanje, Australië, Korea, republiek van, België, Duitsland, Hongkong, Kalkoen
-
Rashmi Verma, MDNational Cancer Institute (NCI)WervingCastratieresistent prostaatcarcinoom | Gemetastaseerd prostaatadenocarcinoom | Stadium IVB Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
-
Jonsson Comprehensive Cancer CenterNog niet aan het wervenProstaatcarcinoom | Stadium IVB Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)Nog niet aan het wervenAnatomische fase II borstkanker AJCC v8 | Anatomische fase III borstkanker AJCC v8 | Borstcarcinoom in een vroeg stadium | Anatomische fase I Borstkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
-
University of Southern CaliforniaNational Cancer Institute (NCI)WervingLokaal gevorderd pancreasadenocarcinoom | Inoperabel pancreasadenocarcinoom | Fase III Pancreaskanker American Joint Committee on Cancer v8Verenigde Staten
-
Jonsson Comprehensive Cancer CenterIngetrokkenProstaat Adenocarcinoom | Prostaatkanker stadium II AJCC v8 | Stadium IIC prostaatkanker AJCC v8 | Stadium IIA prostaatkanker AJCC v8 | Stadium IIB prostaatkanker AJCC v8 | Fase I Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
Klinische onderzoeken op accelerated conformational radiotherapy
-
Tai Po HospitalVoltooid
-
Joris B.W. ElbersErasmus Medical Center; HollandPTCWervingHoofd-hals plaveiselcelcarcinoom | Radiotherapie | Proton therapie | Hypofractionering | Onderdrukking van het immuunsysteemNederland
-
Johns Hopkins UniversityUniversity of Texas at Austin; Baszucki Brain Research Fund; Magnus MedicalVoltooid
-
University Hospital HeidelbergWerving
-
RS MedicalAccelerated Care Plus; Research Institute of Health and Science (RIHSE)Voltooid