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

Royal Marsden NHS Foundation Trust

Status and phase

Completed

Phase 2

Conditions

Oesophageal Carcinoma

Treatments

Drug: Epirubicin, Cisplatin, Capecitabine

Procedure: Surgical Resection

Study type

Interventional

Funder types

Other

Identifiers

NCT00220129

2186

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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