- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
Missouri
-
St. Louis, Missouri, Forente stater, 63110
- Washington University School of Medicine
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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 navn:
Andre navn:
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
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
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Neoplasmer
- Neoplasmer etter nettsted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Tarmsykdommer
- Intestinale neoplasmer
- Rektale sykdommer
- Kolorektale neoplasmer
- Rektale neoplasmer
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Antimetabolitter, antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Beskyttende agenter
- Mikronæringsstoffer
- Vitaminer
- Motgift
- Vitamin B kompleks
- Fluorouracil
- Capecitabin
- Oksaliplatin
- Leucovorin
Andre studie-ID-numre
- 09-0696 / 201106272
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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