Neoadjuvant Epirubicin, Cisplatin and Capecitabine (ECX) Followed by Definitive Chemoradiation With/Without Surgery for Squamous Cell Carcinoma of the Oesophagus
Information source: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Oesophageal Carcinoma
Intervention: Epirubicin, Cisplatin, Capecitabine (Drug); Surgical Resection (Procedure)
Phase: Phase 2
Status: Completed
Sponsored by: Royal Marsden NHS Foundation Trust Official(s) and/or principal investigator(s): David Cunningham, Principal Investigator, Affiliation: Royal Marsden NHS Foundation Trust
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.
Clinical Details
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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 2 year overall survival
Secondary outcome: Objective clinical response rate assessed by computed tomography (CT), endoscopic ultrasound (EUS) and endoscopic biopsyPattern of treatment failure Progression free survival Proportion of patients not achieving clinical complete response and requiring surgery after chemoradiation Treatment related toxicity Time to improvement of dysphagia
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Royal Marsden Hospital, Sutton, Surrey SM2 5PT, United Kingdom
Additional Information
Starting date: November 2002
Last updated: December 15, 2009
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