Neoadjuvant Epirubicin, Cisplatin and Capecitabine (ECX) Followed by Definitive Chemoradiation With/Without Surgery for Squamous Cell Carcinoma of the Oesophagus
This study has been completed.
Sponsor:
Royal Marsden NHS Foundation Trust
Information provided by:
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00220129
First received: September 19, 2005
Last updated: December 15, 2009
Last verified: December 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Oesophageal Carcinoma |
Drug: Epirubicin, Cisplatin, Capecitabine Procedure: Surgical Resection |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Royal Marsden NHS Foundation Trust:
Primary Outcome Measures:
- 2 year overall survival
Secondary Outcome Measures:
- Objective clinical response rate assessed by computed tomography (CT), endoscopic ultrasound (EUS) and endoscopic biopsy
- Pattern 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
| Enrollment: | 16 |
| Study Start Date: | November 2002 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00220129
Locations
| United Kingdom | |
| Royal Marsden Hospital | |
| Sutton, Surrey, United Kingdom, SM2 5PT | |
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
| Principal Investigator: | David Cunningham | Royal Marsden NHS Foundation Trust |
More Information
No publications provided
| Responsible Party: | Jane Lawrence, Royal Marsden NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT00220129 History of Changes |
| Other Study ID Numbers: | 2186 |
| Study First Received: | September 19, 2005 |
| Last Updated: | December 15, 2009 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Esophageal Diseases Esophageal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Head and Neck Neoplasms Capecitabine Cisplatin Epirubicin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013