- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 3
Kontakter och platser
Studieorter
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England
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Birmingham, England, Storbritannien, B15 2TH
- Rekrytering
- Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
-
Kontakt:
- Derek Alderson, MD
- Telefonnummer: 44-121-627-2276
- E-post: d.alderson@bham.ac.uk
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
Vad mäter studien?
Primära resultatmått
Resultatmått |
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Överlevnad
|
Sekundära resultatmått
Resultatmått |
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Livskvalité
|
Sjukdomsfri överlevnad
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Local control
|
Morbidity from surgery and chemotherapy
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Derek Alderson, MD, University Hospital Birmingham
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Neoplasmer
- Neoplasmer efter plats
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Gastrointestinala sjukdomar
- Neoplasmer i huvud och hals
- Esofagussjukdomar
- Esofagusneoplasmer
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Topoisomeras II-hämmare
- Topoisomerasinhibitorer
- Antibiotika, antineoplastiska
- Cisplatin
- Fluorouracil
- Epirubicin
Andra studie-ID-nummer
- MRC-OE05
- CDR0000069457 (Registeridentifierare: PDQ (Physician Data Query))
- EU-20204
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