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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Oesophageal Carcinoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

2 year overall survival

Principal Investigator

David Cunningham

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Marsden NHS Foundation Trust

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

2186

NCT ID:

NCT00220129

Start Date:

November 2002

Completion Date:

Related Keywords:

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

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