EUCTR2011-001858-28-GB
Active, not recruiting
Phase 1
Randomised Clinical Trial of neoadjuvant and adjuvant chemotherapy (Investigator's choice Modified MAGIC or FLOT regimen) vs. neoadjuvant chemoradiation (CROSS protocol) in adenocarcinoma of the oesophagus and oesophago-gastric junction. - Neo-AEGIS
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Adenocarcinoma of the oesophagus and oesophago-gastric junction
- Sponsor
- Cancer Trials Ireland Company Limited By Guarantee
- Enrollment
- 540
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Countries with Group Specific Appendices with sections relating to the inclusion and exclusion criteria, should refer to this documents when reviewing patient eligibility.
- •1\. Histologically verified adenocarcinoma of the oesophagus or oesophago\-gastric junction based on endoscopy(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 investigators 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 F)
- •9\. ASA Grading I\-II (Appendix F).
Exclusion Criteria
- •Countries with Group Specific Appendices with sections relating to the inclusion and exclusion criteria, should refer to this documents when reviewing patient eligibility.
- •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 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.
Outcomes
Primary Outcomes
Not specified
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