Clinical trial NCT00220103: Pre-operative Epirubicin, Cisplatin, and Capecitabine in Patients With Newly Diagnosed Localised Oesophageal Adenocarcinoma
Official title: Pre-operative Epirubicin, Capecitabine (Xeloda) and Cisplatin in Patients With Newly Diagnosed Localised Oesophageal Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adenocarcinoma of Oesophagus
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 80
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: To investigate the efficacy and safety of epirubicin, cisplatin and capecitabine as neoadjuvant therapy prior to radical resection in patients with newly diagnosed operable oesophageal adenocarcinoma.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years.
* Histologically verified adenocarcinoma of the thoracic oesophagus or type 1, 2 and 3 tumours of the oesophagogastric junction (type 1 refers to lower oesophageal, type 2 refers to cardial and type 3 refers to subcardinal cancers).
* AJCC Stage II-III (T2-3 N0-1 M0) (28), as assessed by spiral or multi-slice CT and endoscopic ultrasound, where primary surgery would be considered with curative intent.
* No previous chemotherapy, radiotherapy or other investigational drug treatment for this indication.
* WHO performance status 0,1 or 2.
* Adequate bone marrow function with platelets \> 100 x 109/l; WBC \> 3 x 109/l; neutrophils \> 1.5 x 109/l at the time of study entry.
* Serum bilirubin \< 35 mol/l.
* Serum creatinine \< 180 mol/l and measured creatinine clearance over 60ml/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 surgical resection (T4 or Stage IV or M1a-b)
* 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.
* Patients with disease in any of the following areas on the basis of CT scan and/or endoscopic ultrasound:

  * Evidence of liver, lung or other distant metastases
  * Para-aortic/coeliac lymphadenopathy \> 1cm diameter on CT, \> 6mm diameter on EUS
  * Invasion of airways, aorta, pericardium, or lung
* 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.
* Known malabsorption syndromes.
* Patients with a known hypersensitivity to 5-FU or with a dihydropyrimidine dehydrogenase (DPD) deficiency.

Primary outcomes:
measure: Pathological complete response rate
Secondary outcomes:
measure: Progression free survival
measure: Overall survival
measure: Objective response rate assessed by CT and EUS
measure: Treatment related toxicity including peri-operative complications
measure: Time to improvement of dysphagia
measure: Pattern of treatment failure
measure: To assess the value of high resolution MRI to depict response to treatment and compare it with EUS and histopathology
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
state: Surrey
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: David Cunningham
role: PRINCIPAL_INVESTIGATOR
References: