Randomised Clinical Trial of Neoadjuvant and Adjuvant Chemotherapy (MAGIC Regimen) vs. Neoadjuvant Chemoradiation (CROSS Protocol) in Adenocarcinoma of the Oesophagus and Oesophago-gastric Junction
18 Years
N/A
Both
Adenocarcinoma of the Oesophagus, Adenocarcinoma of the Oesophago-gastric Junction, Oesophageal Tumours, Junctional Tumours, Oesophageal Cancer
Trial Information
Randomised Clinical Trial of Neoadjuvant and Adjuvant Chemotherapy (MAGIC Regimen) vs. Neoadjuvant Chemoradiation (CROSS Protocol) in Adenocarcinoma of the Oesophagus and Oesophago-gastric Junction
Indication:
Patients with cT2-3 N0-1 M0 adenocarcinoma of the oesophagus or junction, based on clinical,
CT-PET, and EUS staging, will be randomised to the MAGIC chemotherapy regimen versus the
CROSS neoadjuvant chemo radiation protocol prior to surgery. Patients will be randomised to
either Arm A (MAGIC regimen of chemotherapy only and surgery) or Arm B (CROSS protocol:
chemotherapy with radiation therapy and surgery as per multimodal protocol).
Eligible patients will be randomised in a 1:1 fashion between the MAGIC regimen or the CROSS
protocol.
Exploratory Study- Translational Research :
All patients enrolled in this trial, will be invited to consent to having some of their
tissue and blood taken for use in future research studies. Following consent from the
patient, tissue biopsy of tumour and/or normal oesophageal tissue will be obtained for
research at the same time as that biopsied for histological diagnosis. In addition, tumour
and/or normal tissue will also be obtained following surgical resection. Patient blood
samples will also be obtained, both before and during treatment. The identification of both
tumour and circulating biomarkers will increase knowledge of the molecular mechanism(s)
underlying treatment response in oesophageal cancer and may facilitate the identification of
biomarkers predicting patient response to treatment.
Inclusion Criteria:
1. Histologically verified adenocarcinoma of the oesophagus or oesophago-gastric
junction.
2. CT- 18FDG-PET and EUS in all patients
3. Staging laparoscopy will be performed for tumours of the abdominal oesophagus,
junction and proximal stomach i.e. AEG II and AEG III (at the investigators
discretion)
4. Pre-treatment stage cT2-3, N0-1, M0
5. No prior abdominal or thoracic radiotherapy
6. Male/female patients aged >18 years.
7. WHO Performance Status 0, 1 or 2
8. ASA I-II
9. Completion of baseline quality of life questionnaire (EORTC QLQ C30).
10. Adequate cardiac function. Patients with a cardiac history should have a cardiology
review and should have a left ventricular ejection fraction > 50% (as determined by
MUGA scan or ECHO).
11. Adequate respiratory function. Patients should have pulmonary function tests
completed with FEV1 > 1.5L
12. Adequate bone marrow function: absolute neutrophil count (ANC) >1.5x10^9/l; white
blood cell count >3x10^9/l; platelets >100x10^9/l; haemoglobin (Hb) >9g/dl (can be
post-transfusion).
13. Adequate renal function: glomerular filtration rate >60ml/minute (calculated or
measured).
14. Adequate liver function: serum bilirubin <1.5x ULN; AST <2.5x ULN and ALP <3x ULN
(ULN as per institutional standard)
15. Written informed consent must be obtained from the patient before any study-trial
specific procedures are performed.
Exclusion Criteria:
1. Tumours of squamous histology.
2. Patients with advanced inoperable or metastatic oesophageal, junctional or gastric
adenocarcinoma.
3. Any prior chemotherapy for gastrointestinal cancer.
4. Prior abdominal or thoracic radiation.
5. Clinically significant (i.e. active) cardiac disease (e.g. symptomatic coronary
artery disease or myocardial infarction within the last 12 months. Patients with any
history of clinically significant cardiac failure are excluded from study entry.
6. Clinical COPD with significant obstructive airways disease classified by FEV1 < 1.5 L
or PaO2 less than 9kPa on room air
7. Known peripheral neuropathy >Grade 1 (absence of deep tendon reflexes as the sole
neurological abnormality does not render the patient ineligible).
8. Known positive tests for human immunodeficiency virus (HIV) infection, , acute or
chronic active hepatitis B infection.
9. Any other malignancies within the last 5 years (other than curatively treated basal
cell carcinoma of the skin and/or in situ carcinoma of the cervix)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Outcome Description:
Overall survival will be calculated from the date of randomisation and an event registered on the date of death from any cause. Patients lost to follow up, or those with no death recorded on the day the database is frozen, will be censored on the date of last follow up.
Outcome Time Frame:
At end of trial- up to 3 years in follow up
Safety Issue:
No
Principal Investigator
John V. Reynolds, Professor
Investigator Role:
Principal Investigator
Investigator Affiliation:
Trinity Centre, St. James's Hospital, Dublin 8
Authority:
Ireland: Irish Medicines Board
Study ID:
ICORG 10-14
NCT ID:
NCT01726452
Start Date:
January 2013
Completion Date:
Related Keywords:
- Adenocarcinoma of the Oesophagus
- Adenocarcinoma of the Oesophago-gastric Junction
- Oesophageal Tumours
- Junctional Tumours
- Oesophageal Cancer
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Esophageal Diseases
- Esophageal Neoplasms
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