Adenocarcinoma of the oesophagus and oesophagastric junction MedDRA version: 21.1 Level: LLT Classification code 10066354 Term: Adenocarcinoma of the gastroesophageal junction System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: PT Classification code 10030137 Term: Oesophageal adenocarcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Carboplatin
Product Name: Carboplatin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: CARBOPLATIN
CAS Number: 41575-94-4
Concentration unit: mg/ml milligram
Sponsors
Cancer Trials Ireland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically verified adenocarcinoma of the oesophagus, or oesophago-gastric junction based on OGD. 2. CT- 18FDG-PET performed in all patients for disease staging 3. EUS in all patients unless luminal obstruction precludes sensitivity of the test. 4. Staging laparoscopy will be performed at the investigator’s discretion for locally advanced AEG II and AEG III tumours. 5. Pre-treatment stage cT2-3, N0-3, M0. 6. Maximum tumour length should be no more than 8cm (equal to 8 cm is acceptable). 7. Male/female patients aged =18 years. 8. ECOG Performance Status 0, 1 or 2 (Appendix D). 9. ASA Grading I-II (Appendix D). 10. Adequate cardiac function. For all patients, an ejection fraction of > 50% is required. If patients have a known history of significant cardiac disease (e.g. known ischemic disease, cardiomyopathy) an ejection fraction > 50% and cardiac clearance by a consultant cardiologist for major surgery and cancer therapies is required. 11. Adequate respiratory function. Patients should have pulmonary function tests completed with a minimum FEV1=1.5L. CPEX acceptable. 12. Adequate bone marrow function: absolute neutrophil count (ANC) >1.5x109/l; white blood cell count > 3x109/l; platelets > 100x109/l; haemoglobin (Hb) > 9g/dl (can be post-transfusion). 13. Adequate renal function: glomerular filtration rate > 60ml/minute calculated using the Cockcroft-Gault Formula (Appendix M). 14. Adequate liver function: serum bilirubin = ULN; AST =65 years) yes F.1.3.1 Number of subjects for this age range 270
Exclusion criteria
Exclusion criteria: 1. Tumours of squamous histology. 2. Patients with advanced inoperable or metastatic oesophageal, junctional or gastric adenocarcinoma. 3. Disease length (total length of tumour plus node) greater than 10 cm (up to 10 cm will be allowed) -measured by any modality or, if appropriate, combination of modalities-, unless in the opinion of the investigator in discussion with national RT lead, it is felt that Organ At Risk (OAR) constraints are likely to be achievable. 4. Any prior chemotherapy for gastrointestinal cancer. 5. Prior abdominal, thoracic, chest wall or breast radiotherapy. 6. Patients who are unfit for surgery or cancer treatments based on cardiac disease. 7. Patients with acute systemic infections. 8. Patients who are receiving treatment with sorivudine or its chemical related analogues, such as brivudine which is contraindicated with capecitabine and 5-fluorouracil administration. 9. Clinical Chronic Obstructive Pulmonary Disease (COPD) with significant obstructive airways disease classified by FEV1 Grade 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible). 11. Known positive tests for human immunodeficiency virus (HIV) infection, acute or chronic active hepatitis B infection. 12. 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). 13. Participation in other clinical trials of investigational or marketed agents for the treatment of oesophageal cancer or other diseases within 30 days prior to registration. UK sites please refer to Group Specific Appendix. 14. Women who are pregnant or breastfeeding. 15. Psychiatric illness/social situations that would limit compliance with study requirements. 16. Known Dihydropyrimidine dehydrogenase (DPD) deficiency. Sites in the UK, France, Sweden, Netherlands must refer to individual Group Specific Appendices (GSA) / Country Specific Appendices (CSA) for country-specific inclusion & exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate one, two and three year survival of patients treated with resection plus neoadjuvant and adjuvant chemotherapy versus resection plus neoadjuvant chemo radiotherapy.;Secondary Objective: 1) To evaluate the effect of both neoadjuvant regimens on clinical and pathological response rate (in particular relief of dysphagia , improvement in HRQL and endoscopic regression), tumour regression grade,surgical resection rate (including resectability and pathologic R0 Resection), node-positivity, post-operative pathology, disease-free survival, time to treatment failure, site of treatment failure, toxicity and post-operative complications. 2) The collection of blood and tissue samples for storage in the bio bank for future research (applicable to sites in Ireland only). ;Primary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: The primary endpoint is overall survival which will be calculated from the date of registration to 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Clinical and pathological response rate • Tumour Regression Grade • Surgical Resection Rate • Node-positivity • Post-operative Pathological staging • Disease-free survival • Time to treatment failure • Site of treatment failure • Toxicity • Post-operative complications • EORTC C30 Health Related Quality of life;Timepoint(s) of evaluation of this end point: Statistical considerations are based on 3-year overall or disease-free survival. | — |
Countries
Denmark, France, Ireland, Sweden, United Kingdom
Contacts
Public ContactHead of Clinical Operations
Cancer Trials Ireland
Outcome results
None listed