Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Royal Marsden NHS Foundation Trust
Treatments:
Capecitabine
Cisplatin
Epirubicin
Criteria
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