- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00041262
Combination Chemotherapy in Treating Patients With Esophageal Cancer
A Prospective Randomized Trial Comparing Standard Chemotherapy Followed By Resection Versus Infusional Chemotherapy In Patients With Resectable Adenocarcinoma Of The Oesophagus
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective in treating esophageal cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy in treating patients who are undergoing surgery for esophageal cancer.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
OBJECTIVES:
- Compare survival and quality of life of patients with resectable adenocarcinoma of the esophagus treated prior to surgery with standard chemotherapy comprising cisplatin and fluorouracil versus prolonged infusional chemotherapy comprising cisplatin, epirubicin, and fluorouracil.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
- Arm I (Standard chemotherapy): Patients receive cisplatin IV over 4 hours on days 1-4 and fluorouracil IV continuously on days 1-4. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
- Arm II (Infusional chemotherapy): Patients receive cisplatin IV over 4 hours on day 1, epirubicin IV on day 1, and fluorouracil IV continuously. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo surgery 4-6 weeks after the last dose of fluorouracil in arm I or anytime after the fluorouracil infusion is completed in arm II.
Quality of life is assessed at baseline, immediately before starting the last course of chemotherapy, immediately before surgery, 6 weeks post-operatively, and at 6, 9, 12, 18, and 24 months after randomization.
Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: Approximately 1,300 patients (650 per treatment arm) will be accrued for this study.
Studietype
Registrering (Forventet)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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England
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Birmingham, England, Storbritannia, B15 2TH
- Rekruttering
- Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
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Ta kontakt med:
- Derek Alderson, MD
- Telefonnummer: 44-121-627-2276
- E-post: d.alderson@bham.ac.uk
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the esophagus or type 1 or 2 tumors of the gastroesophageal junction
- Stage IIB or greater by spiral or multi-slice CT scan and endoscopic ultrasound
- Amenable to primary surgery with curative intent
- No para-aortic/celiac lymphadenopathy greater than 1 cm on CT scan and/or greater than 6 mm on endoscopic ultrasound
- No disease invading the airways, aorta, pericardium, or lung
- No liver, lung, or other distant metastases
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- WHO 0-1
Life expectancy:
- Not specified
Hematopoietic:
- WBC greater than 3,000/mm3
- Platelet count greater than 100,000/mm3
Hepatic:
- Liver function tests no greater than 1.5 times normal
Renal:
- Glomerular filtration rate greater than 60 mL/min
Cardiovascular:
- Ejection fraction greater than 50% OR
- Normal echocardiograph
Pulmonary:
- FEV1 greater than 1.5 L
Other:
- Not pregnant or nursing
- No prior primary malignancy
- No significant medical condition that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
Hva måler studien?
Primære resultatmål
Resultatmål |
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Overlevelse
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Sekundære resultatmål
Resultatmål |
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Livskvalitet
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Sykdomsfri overlevelse
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Local control
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Morbidity from surgery and chemotherapy
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Derek Alderson, MD, University Hospital Birmingham
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Neoplasmer
- Neoplasmer etter nettsted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Neoplasmer i hode og nakke
- Esophageal sykdommer
- Neoplasmer i spiserøret
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antimetabolitter, antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Topoisomerase II-hemmere
- Topoisomerasehemmere
- Antibiotika, antineoplastisk
- Cisplatin
- Fluorouracil
- Epirubicin
Andre studie-ID-numre
- MRC-OE05
- CDR0000069457 (Registeridentifikator: PDQ (Physician Data Query))
- EU-20204
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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