NCT00041262

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,300

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2002

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.8 years until next milestone

Study Start

First participant enrolled

November 1, 2004

Completed
Last Updated

August 12, 2013

Status Verified

March 1, 2007

First QC Date

July 8, 2002

Last Update Submit

August 9, 2013

Conditions

Esophageal Cancer

Keywords

stage IIB esophageal cancerstage IIIA esophageal cancerstage IIIB esophageal canceradenocarcinoma of the esophagus

Outcome Measures

Primary Outcomes (1)

  • Survival

Secondary Outcomes (4)

  • Disease-free survival

  • Local control

  • Morbidity from surgery and chemotherapy

  • Quality of life

Interventions

cisplatinDRUG
epirubicin hydrochlorideDRUG
fluorouracilDRUG
conventional surgeryPROCEDURE
neoadjuvant therapyPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

Birmingham, England, B15 2TH, United Kingdom

RECRUITING

Related Publications (1)

  • Alderson D, Cunningham D, Nankivell M, Blazeby JM, Griffin SM, Crellin A, Grabsch HI, Langer R, Pritchard S, Okines A, Krysztopik R, Coxon F, Thompson J, Falk S, Robb C, Stenning S, Langley RE. Neoadjuvant cisplatin and fluorouracil versus epirubicin, cisplatin, and capecitabine followed by resection in patients with oesophageal adenocarcinoma (UK MRC OE05): an open-label, randomised phase 3 trial. Lancet Oncol. 2017 Sep;18(9):1249-1260. doi: 10.1016/S1470-2045(17)30447-3. Epub 2017 Aug 4.

    PMID: 28784312DERIVED

MeSH Terms

Conditions

Esophageal NeoplasmsAdenocarcinoma Of Esophagus

Interventions

CisplatinEpirubicinFluorouracilNeoadjuvant Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsDoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCombined Modality TherapyTherapeutics

Study Officials

  • Derek Alderson, MD

    University Hospital Birmingham

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 8, 2002

First Posted

January 27, 2003

Study Start

November 1, 2004

Last Updated

August 12, 2013

Record last verified: 2007-03

Locations

GB(1)