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

NCT00220129 | Completed Phase 2

• 1 other identifier: 2186
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oesophageal Carcinoma

Outcome Measures

Primary Outcomes (1)

• 2 year overall survival

Secondary Outcomes (6)

• 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

Interventions

Epirubicin, Cisplatin, Capecitabine DRUG

Surgical Resection PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

Royal Marsden Hospital

Sutton, Surrey, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Epirubicin; Cisplatin; Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• David Cunningham

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 19, 2005
• First Posted: September 22, 2005
• Study Start: November 1, 2002
• Last Updated: December 16, 2009

Record last verified: 2009-12

Locations

GB (1)