Combination Chemotherapy in Treating Patients With Esophageal Cancer

• ClinicalTrials.gov Identifier: NCT00041262
• Recruitment Status: Unknown
• First Posted: January 27, 2003
• Last Update Posted: August 12, 2013
• Sponsor: Medical Research Council
• Information provided by: National Cancer Institute (NCI)

Tracking Information

• First Submitted Date: July 8, 2002
• First Posted Date: January 27, 2003
• Last Update Posted Date: August 12, 2013
• Study Start Date: November 2004
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: June 4, 2007): Survival
• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: June 4, 2007)

• Disease-free survival
• Local control
• Morbidity from surgery and chemotherapy
• Quality of life

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Combination Chemotherapy in Treating Patients With Esophageal Cancer
• Official Title: A Prospective Randomized Trial Comparing Standard Chemotherapy Followed By Resection Versus Infusional Chemotherapy In Patients With Resectable Adenocarcinoma Of The Oesophagus

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.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Primary Purpose: Treatment
• Condition: Esophageal Cancer

Intervention

• Drug: cisplatin
• Drug: epirubicin hydrochloride
• Drug: fluorouracil
• Procedure: conventional surgery
• Procedure: neoadjuvant therapy

• Study Arms: Not Provided
• Publications *: 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: November 8, 2006): 1300
• Original Enrollment: Not Provided
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT00041262
• Other Study ID Numbers: MRC-OE05; CDR0000069457 ( Registry Identifier: PDQ (Physician Data Query) ); EU-20204
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: Medical Research Council
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Derek Alderson, MD; University Hospital Birmingham

• PRS Account: National Cancer Institute (NCI)
• Verification Date: March 2007