- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01060007
Five Fractions of Radiotherapy Followed by Full Dose FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer
A Phase II Evaluation of Five Fractions of Radiotherapy Followed by Full Dose FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Missouri
-
St. Louis, Missouri, Forenede Stater, 63110
- Washington University School of Medicine
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Biopsy proven adenocarcinoma of the rectum
- Patient evaluated by surgeon and found to be a potential surgical candidate. Since the primary objectives are response to chemoradiation and acute toxicity, lesions which are initially unresectable are eligible-provided the surgeon feels that, if there is sufficient response, surgery could become feasible.
- Clinical evidence of T3 or T4 disease. This can be by imaging studies (see or by physical findings (tethering on palpation for T3 lesions or invasion of a neighboring organ for T4 lesions)
- Karnofsky Performance Status at >60
- Laboratory criteria:
- Absolute neutrophil count >= 1.5 K
- Platelets >= 100 K
- Total Bilirubin <= 2.0;
- SGOT and Alkaline Phosphatase <= 2 x upper limit of normal
- Creatinine < 2.0
- Hemoglobin >= 8.0
- Informed consent signed
- Tumor measurable in at least one dimension. This may be, e.g. length and/or width measured endoscopically or on digital rectal examination, and maximum rectal wall thickness determined by imaging studies.
- Estimated longevity at least 12 months
- Patients with distant metastatic disease will be eligible if they satisfy all other conditions
Exclusion Criteria:
- Pregnant women, children < 18 years, or patients unable to give informed consent
- Patients with a past history of pelvic radiotherapy.
- Patients with any other malignancy within the past 5 years except: skin cancer or in-situ cervical cancer
- Patients with known allergy/intolerance to 5FU, Leucovorin, Oxaliplatin, Capecitabine
- Prior chemotherapy for colorectal cancer.
- Grade >= 2 peripheral neuropathy
- Any condition which, in the opinion of the treating medical oncologist, renders the patient unfit for 5FU (oral capecitabine if 5FU is unavailable), Leucovorin, Oxaliplatin chemotherapy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Neoadjuvant radiation followed by FOLFOX
Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week. FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat ever other week for a total of 4 courses (this equals 6 weeks). If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days. |
Andre navne:
Andre navne:
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Rate of T Stage Downstaging
Tidsramme: Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)
|
T stage downstaging is defined as clinical pretreatment American Joint Committee on Cancer T stage (cT) being greater than pathologic T stage at surgery (ypT).
|
Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)
|
Preoperative Gastrointestinal Morbidity
Tidsramme: Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)
|
As measured by participants who experience grade 3 or higher gastrointestinal morbidity
|
Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Incidence of Any Late Grade 3 or Higher Morbidity
Tidsramme: Preoperative (mean time from start of radiation to surgery 17.3 weeks (SD +/- 2.9 weeks)
|
Preoperative (mean time from start of radiation to surgery 17.3 weeks (SD +/- 2.9 weeks)
|
|
Incidence of Post Chemoradiotherapy Grade 3 or Higher Morbidity
Tidsramme: 1 year (completion of all treatment)
|
1 year (completion of all treatment)
|
|
Local Control
Tidsramme: 30 months
|
|
30 months
|
Rate of Overall Control
Tidsramme: 1 year
|
1 year
|
|
Rate of Locoregional Control
Tidsramme: 1 year
|
1 year
|
|
Freedom From Disease Relapse
Tidsramme: 30 months
|
Kaplan-Meier projections.
|
30 months
|
Determine Quality of Anorectal Function
Tidsramme: Up to 1 year
|
Anorectal function was measured by the participant's response to the FACT-C questionnaire question "I have control of my bowels".
The answers ranged from 0=not at all to 4=very much.
|
Up to 1 year
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
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
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer
- Neoplasmer efter sted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Tarmsygdomme
- Intestinale neoplasmer
- Endetarmssygdomme
- Kolorektale neoplasmer
- Rektale neoplasmer
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Beskyttelsesagenter
- Mikronæringsstoffer
- Vitaminer
- Modgift
- Vitamin B kompleks
- Fluorouracil
- Capecitabin
- Oxaliplatin
- Leucovorin
Andre undersøgelses-id-numre
- 09-0696 / 201106272
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Rektale neoplasmer
-
Guangzhou First People's HospitalAfsluttet
-
Institut BergoniéAfsluttetMedium og Lower Rectal CancerFrankrig
-
Fundación de investigación HMSyntax for Science, S.LAfsluttetLocally Advanced Rectal Cancer (LARC)Spanien
-
King Faisal Specialist Hospital & Research CenterAfsluttetColon Rectal Cancer Duke Stage StagevalSaudi Arabien
-
Austrian Breast & Colorectal Cancer Study GroupAfsluttetRectal Cancer Dukes B, Dukes CØstrig
-
University Health Network, TorontoAfsluttet
-
Sir Run Run Shaw HospitalAktiv, ikke rekrutterendeMSS Locally Advanced Rectal AdenocarcinomaKina
-
Sunnybrook Health Sciences CentreUniversity of Toronto; Sunnybrook Research InstituteAfsluttetRectal Neoplasma Carcinoma in Situ AdenocarcinomaCanada
-
Philips HealthcarePhilips Electronics Nederland B.V. acting through Philips CTO organizationAfsluttetMalignt lymfom i lymfeknuder i lyskeregionen | Malignt lymfom af lymfeknuder i aksillært | Malignt lymfom af lymfeknuder i livmoderhalsen | Karcinom i parotidkirtlen | Colon Rectal Cancer Tubulovillous Adenocarcinoma | Tumor af blødt væv i hoved, ansigt og halsHolland
-
Stanford UniversityAfsluttetGastrointestinale neoplasmer | Kræft i bugspytkirtlen | Spiserørskræft | Anal kræft | Hepatobiliær neoplasma | Gastroøsofageal kræft | Galdeblærekarcinom | Leverkarcinom | Galdeblærekræft | Gastrointestinal stromal tumor (GIST) | Karcinom i tyktarmen | Gastrisk (mave) kræft | Galdevejscarcinom | Colon Rectal Cancer AdenocarcinomForenede Stater
Kliniske forsøg med Oxaliplatin
-
Xijing HospitalUkendt
-
Lin ChenUkendtGastrisk AdenocarcinomKina
-
University of California, DavisNational Cancer Institute (NCI)AfsluttetStadie IV brystkræftForenede Stater
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)AfsluttetLivmoderhalskræft | Primær peritoneal kræftForenede Stater, Canada
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)AfsluttetLivmoderhalskræftForenede Stater, Canada
-
Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI)AfsluttetHoved- og halskræftForenede Stater
-
St. Jude Children's Research HospitalNational Cancer Institute (NCI)AfsluttetUspecificeret fast tumor i barndommen, protokolspecifikForenede Stater
-
Gustave Roussy, Cancer Campus, Grand ParisNational Cancer Institute, FranceSuspenderet
-
University of ChicagoNational Cancer Institute (NCI)AfsluttetBlærekræft | Overgangscellekræft i nyrebækkenet og urinlederenForenede Stater, Canada
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)AfsluttetEndometriecancerForenede Stater