Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Neoadjuvant Epirubicin, Cisplatin and Capecitabine (ECX) Followed by Definitive Chemoradiation With/Without Surgery for Squamous Cell Carcinoma of the Oesophagus

This study has been completed.
Sponsor:
Information provided by:
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00220129
First received: September 19, 2005
Last updated: December 15, 2009
Last verified: December 2009

September 19, 2005
December 15, 2009
November 2002
Not Provided
2 year overall survival
Same as current
Complete list of historical versions of study NCT00220129 on ClinicalTrials.gov Archive Site
  • Objective clinical response rate assessed by computed tomography (CT), endoscopic ultrasound (EUS) and endoscopic biopsy
  • Pattern of treatment failure
  • Progression free survival
  • Proportion of patients not achieving clinical complete response and requiring surgery after chemoradiation
  • Treatment related toxicity
  • Time to improvement of dysphagia
  • Objective clinical response rate assessed by CT, EUS and endoscopic biopsy
  • Pattern of treatment failure
  • Progression free survival
  • Proportion of patients not achieving clinical complete response and require surgery after chemoradiation
  • Treatment related toxicity
  • Time to improvement of dysphagia
Not Provided
Not Provided
 
Neoadjuvant Epirubicin, Cisplatin and Capecitabine (ECX) Followed by Definitive Chemoradiation With/Without Surgery for Squamous Cell Carcinoma of the Oesophagus
Neoadjuvant Epirubicin, Cisplatin and Capecitabine (Xeloda) [ECX] Followed by Definitive Chemoradiation With or Without Surgery for Patients With Newly Diagnosed Localized Squamous Cell Carcinoma of the Oesophagus

This is a study to investigate the efficacy and safety of epirubicin, cisplatin and capecitabine (ECX) as neoadjuvant therapy prior to radical chemoradiotherapy using capecitabine and cisplatin as radio-sensitisers in patients with newly diagnosed localized squamous cell carcinoma of the oesophagus.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Oesophageal Carcinoma
  • Drug: Epirubicin, Cisplatin, Capecitabine
  • Procedure: Surgical Resection
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
Not Provided
Not Provided

Inclusion Criteria:

  • Age > 18 years.
  • Histologically verified squamous cell carcinoma of the cervical or thoracic oesophagus
  • American Joint Committee on Cancer (AJCC) Stage I-III (T1-3 N0-1 M0) (33), as assessed by spiral or multi-slice computed tomography (CT) and endoscopic ultrasound, where radical chemoradiation would be considered with curative intent.
  • No previous chemotherapy, radiotherapy or other investigational drug treatment for this indication.
  • World Health Organization (WHO) performance status 0,1 or 2.
  • Adequate bone marrow function with platelets > 100 x 10^9/l; white blood cells (WBC) > 3 x 10^9/l; neutrophils > 1.5 x 10^9/l at the time of study entry.
  • Serum bilirubin < 35 micromol/l.
  • Serum creatinine < 180 micromol/l and measured creatinine clearance over 60 ml/min.
  • No concurrent uncontrolled medical condition.
  • No previous malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix in the last 10 years.
  • Life expectancy > 3 months.
  • Adequate contraceptive precautions if relevant.
  • Informed written consent.

Exclusion Criteria:

  • The presence of locally advanced or metastatic disease precluding curative chemoradiation (T4 or Stage IV or M1a-b) or disease not encompassable in a radical radiotherapy field.
  • Total dysphagia (O'Rourke's swallowing function scoring system 5) precluding swallowing of capecitabine even when crushed.
  • Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
  • Intracerebral metastases or meningeal carcinomatosis.
  • New York Heart Association classification Grade III or IV.
  • Uncontrolled angina pectoris.
  • Pregnancy or breast feeding.
  • Impaired renal function with measured creatinine clearance less than 60 ml/min.
  • Previous investigational study drug
  • Known malabsorption syndromes
  • Patients with a known hypersensitivity to fluorouracil (5-FU) or with a dihydropyrimidine dehydrogenase (DPD) deficiency
  • Hearing loss
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00220129
2186
No
Jane Lawrence, Royal Marsden NHS Foundation Trust
Royal Marsden NHS Foundation Trust
Not Provided
Principal Investigator: David Cunningham Royal Marsden NHS Foundation Trust
Royal Marsden NHS Foundation Trust
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP