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

Oesophageal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00220129
• Other study ID #: 2186
• Status: Completed
• Phase: Phase 2
• First received: September 19, 2005
• Last updated: December 15, 2009
• Start date: November 2002

Study information

• Verified date: December 2009
• Source: Royal Marsden NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Oesophageal Carcinoma

Intervention

Drug:
• Epirubicin, Cisplatin, Capecitabine

Procedure:
• Surgical Resection

Locations

Country	Name	City	State
United Kingdom	Royal Marsden Hospital	Sutton	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2 year overall survival
Secondary	Objective clinical response rate assessed by computed tomography (CT), endoscopic ultrasound (EUS) and endoscopic biopsy
Secondary	Pattern of treatment failure
Secondary	Progression free survival
Secondary	Proportion of patients not achieving clinical complete response and requiring surgery after chemoradiation
Secondary	Treatment related toxicity
Secondary	Time to improvement of dysphagia