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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 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

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

Page last updated: August 20, 2015

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