Trials / Completed
CompletedNCT01726452
NEOadjuvant Trial in Adenocarcinoma of the oEsophagus and oesophagoGastric Junction International Study (Neo-AEGIS)
Neo-AEGIS (NEOadjuvant Trial in Adenocarcinoma of the oEsophagus and oesophagoGastric Junction International Study): Randomised Clinical Trial of Neoadjuvant and Adjuvant Chemotherapy (Modified MAGIC or FLOT Regimen) vs. Neoadjuvant Chemoradiation (CROSS Protocol) in Adenocarcinoma of the Oesophagus and Oesophago-gastric Junction
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 377 (actual)
- Sponsor
- Cancer Trials Ireland · Network
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicentre phase III open-labelled, randomised controlled trial. Eligible patients will be randomised in a 1:1 fashion between neoadjuvant and adjuvant chemotherapy (Investigator's choice modified MAGIC (ECF/ECX or EOF/EOX) or FLOT regimen) and surgery or Arm B (CROSS protocol: chemotherapy with radiation therapy and surgery as per multimodal protocol). Primary 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(s): To evaluate the effect of both neoadjuvant regimens on clinical and pathological response rate (in particular relief of dysphagia, improvement in health related quality of life (HRQL), endoscopic regression, and CT-PET evidence of tumour response), tumour regression grade, node-positivity, post-operative pathology, disease-free survival, time to treatment failure, toxicity, post-operative complications and Health Related Quality of Life (HRQL). Exploratory Objective(s): Translational Research: The collection of blood and tissue samples for storage in the bio bank for future research.
Detailed description
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 modified MAGIC (ECF/ECX or EOF/EOX) or FLOT regimen and chemotherapy regimen versus the CROSS neoadjuvant chemo radiation protocol prior to surgery. Patients will be randomised to either Arm A (modified MAGIC or FLOT 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 modified MAGIC or FLOT regimen or the CROSS protocol. Exploratory Study- Translational Research : The collection of blood and tissue samples for storage in the bio bank for future research. Patients enrolled in this trial at the St James's' Hospital site, 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.
Conditions
- Adenocarcinoma of the Oesophagus
- Adenocarcinoma of the Oesophago-gastric Junction
- Oesophageal Tumours
- Junctional Tumours
- Oesophageal Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Epirubicin | 50mg/m2 on Day 1 of each cycle only (i.e. every 21 days) |
| DRUG | Cisplatin / Oxaliplatin | Cisplatin, 60mg/m2 on day 1 of each cycle only (i.e. every 21 days). OR Oxaliplatin,130 mg/m2 on Day 1 of each cycle (i.e. every 21 days) The choice between administering Cisplatin or Oxaliplatin is at the discretion of the investigator. |
| DRUG | 5 Flourouracil/ Capecitabine | 5-Flourouracil 200 mg/m2/day every day for 21 days OR Capecitabine 625 mg/m2 twice daily orally). The choice between administering 5 Flourouracil or Capecitabine is at the discretion of the investigator. |
| RADIATION | (41.4 Gy/23 fractions) | Patient will receive 4.5 weeks of radiation therapy (41.4 Gy/23 fractions). |
| DRUG | Paclitaxel | 50mg/ m2 Paclitaxel dose administered on Days 1, 8, 15,22 and 29. Dexamethasone, Chlorphenamine and Ranitidine dose given per local standard practice. NACL infusion per local standard practice. Ondansetron dose given per local standard practice on Days 1, 8, 15, 22 and 29. |
| DRUG | Carboplatin | Dose determined as per calculation, infused on Days 1, 8, 15, 22 and 29 |
| DRUG | Docetaxel | Docetaxel, 50 mg/m², day 1 of each cycle (i.e. every 14 days) |
| DRUG | Oxaliplatin | 85 mg/m², day 1 of each cycle (i.e. every 14 days) |
| DRUG | Leucovorin | 200 mg/m², day 1 of each cycle (i.e. every 14 days). |
| DRUG | 5-Fluorouracil | 2600 mg/m² Day 1 of each cycle (i.e. every 14 days) Dexamethasone or equivalent, 8mg, twice daily, Day before, day of and day after OR administered as per standard practice |
Timeline
- Start date
- 2013-01-24
- Primary completion
- 2022-08-04
- Completion
- 2022-08-04
- First posted
- 2012-11-15
- Last updated
- 2022-09-30
Locations
29 sites across 5 countries: Denmark, France, Ireland, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT01726452. Inclusion in this directory is not an endorsement.