Combination Chemotherapy in Treating Patients With Esophageal Cancer

NCT ID: NCT00041262

Last Updated: 2013-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 1300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30

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.

Detailed Description

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.

Conditions

Esophageal Cancer

Keywords

stage IIB esophageal cancer; stage IIIA esophageal cancer; stage IIIB esophageal cancer; adenocarcinoma of the esophagus

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

cisplatin

Intervention Type: DRUG

epirubicin hydrochloride

Intervention Type: DRUG

fluorouracil

Intervention Type: DRUG

conventional surgery

Intervention Type: PROCEDURE

neoadjuvant therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Research Council

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Derek Alderson, MD

Role: STUDY_CHAIR

University Hospital Birmingham

Locations

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

Birmingham, England, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Facility Contacts

Derek Alderson, MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 28784312 (View on PubMed)

Other Identifiers

CDR0000069457

Identifier Type: REGISTRY

Identifier Source: secondary_id

EU-20204

Identifier Type: -

Identifier Source: secondary_id

MRC-OE05

Identifier Type: -

Identifier Source: org_study_id