Clinical trial NCT00220129: Neoadjuvant Epirubicin, Cisplatin and Capecitabine (ECX) Followed by Definitive Chemoradiation With/Without Surgery for Squamous Cell Carcinoma of the Oesophagus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oesophageal Carcinoma
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 2 year overall survival
Secondary outcomes:
measure: Objective clinical response rate assessed by computed tomography (CT), endoscopic ultrasound (EUS) and endoscopic biopsy
measure: Pattern of treatment failure
measure: Progression free survival
measure: Proportion of patients not achieving clinical complete response and requiring surgery after chemoradiation
measure: Treatment related toxicity
measure: Time to improvement of dysphagia
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
state: Surrey
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: David Cunningham
role: PRINCIPAL_INVESTIGATOR
References: