Etude : Neo-AEGIS /



ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.


Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : Neo-AEGIS

Nom :

Traitement : Néoadjuvant / Adjuvant

Type d'étude : Ciblage moléculaire / Innovation thérapeutique

Dernière MÀJ : 05/11/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Essai international de traitement NEO-adjuvant dans les Adénocarcinomes de l’oEsophage et de la jonction oesoGastrique : Essai randomisé comparant la chimiothérapie néo-adjuvante et adjuvante (protocole MAGIC modifié de chimiothérapie péri-opératoire) versus la radio-chimiothérapie néo-adjuvante (protocole CROSS) dans les adénocarcinomes de l’oesophage et de la jonction oesogastrique.

Spécialité : Organes digestifs
Localisation : C15 - Tumeur maligne de l'oesophage
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : Study Arms:

- Experimental: A (MAGIC)
MAGIC regimen: Arm A consists of 3 cycles of chemotherapy pre-surgery and a further 3 cycles of chemotherapy post-surgery. Each cycle of chemotherapy lasts 21 days/3 weeks. The drugs used in the MAGIC regimen include Epirubicin, Cisplatin and 5-Flourouracil/ Capecitabine
Interventions:
- Drug: Epirubicin
- Drug: Cisplatin
- Drug: 5 Flourouracil/ Capecitabine

- Experimental: B (CROSS)
Arm B consists of the CROSS protocol, which includes a combination of chemotherapy and radiotherapy prior to surgery. The patient will receive 5 weeks of radiation therapy and 5 weekly cycles of chemotherapy. The radiation will generally commence on the 1st day of treatment and will run for 5 weeks as follows: days 1-5, days 8-12, days 15-19, days 22-26 and days 29-31 inclusive. The chemotherapy and radiotherapy will run concurrently over a 5-week period. Chemotherapy is given by intravenous infusion on days 1, 8, 15, 22 and 29.
Interventions:
- Radiation: (41.4 Gy/23 fractions)
- Drug: Paclitaxel
- Drug: Carboplatin

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.

Phase : III

Stade : Localisé

1
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Histologically verified adenocarcinoma of the oesophagus or oesophago-gastric junction based on endoscopy (OGD)
- CT-18FDG-PET performed in all patients for disease staging.
EUS in all patients unless luminal obstruction precludes sensitivity of the test.
- Staging laparoscopy performed at the investigator's discretion for locally advanced AEG II and AEG III tumours .
- Pre-treatment stage cT2-3, N0-3, M0.
- Maximum tumour length should be no more than 8cm (equal to 8 cm is acceptable)
- Male/female patients aged ≥18 years
- ECOG Performance Status 0, 1 or 2 (Appendix F).
- ASA I-II (Appendix F).
- Adequate cardiac function. For all patients, an ejection fraction of > 50% is required. If patients have a known cardiac history (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.
- Adequate respiratory function. Patients should have pulmonary function tests completed with a minimum FEV1 ≥ 1.5L. CPEX acceptable
- 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).
- Adequate renal function: glomerular filtration rate >60ml/minute calculated using the Cockcroft-Gault Formula (Appendix O).
- Adequate liver function: serum bilirubin <1.5x ULN; AST <2.5x ULN and ALP <3x ULN (ULN as per institutional standard).
- Written informed consent must be obtained from the patient before any study-trial specific procedures are performed.
- Women of child-bearing potential and male subjects must agree to use an effective barrier method of contraception for up to 6 months following discontinuation of therapy. Effective contraception is defined as any medically recommended (or combination of methods) as per standard of care.
- Women of childbearing potential must have pregnancy excluded by urine or serum beta-HCG testing within 7 days prior to treatment.

Critères de non-inclusion : - Tumours of squamous histology.
- Patients with advanced inoperable or metastatic oesophageal, junctional or gastric adenocarcinoma.
- Disease length (total length of tumour plus node) greater than 10cm (up to 10 cm will be allowed) -as 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.
- Any prior chemotherapy for gastrointestinal cancer.
- Prior abdominal or thoracic radiotherapy.
- Patients who are unfit for surgery or cancer treatments based on cardiac disease.
- Patients with acute systemic infections.
- Patients who are receiving treatment with sorivudine or its chemical related analogues, such as brivudine which is contraindicated with capecitabine and 5-fluorouracil administration.
- Clinical COPD with significant obstructive airways disease classified by FEV1 < 1.5 L or PaO2 less than 9kPa on room air
- Known peripheral neuropathy >Grade 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible).
- Known positive tests for human immunodeficiency virus (HIV) infection, acute or chronic active hepatitis B infection.
- 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)
- Participation in other clinical trials of investigational or marketed agents for the treatment of oesophageal cancer or other diseases within 30 days from registration. UK sites please refer to Group Specific Appendix
- Women who are pregnant or breastfeeding.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
Promoteur :
Cancer Trials Ireland
Type de sponsor : Institutionnel
00000 HORS FRANCE

Coordonnateur :
John V. Reynolds, Professor
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Professeur Guillaume PIESSEN

TEC / ARC / IDE :
Justine LEROOY
justine.lerooy@
chru-lille.fr
Tel: 03 20 44 47 86 (ou 03 20 44 59 62) Fax: 03 20 44 59 14

Ouverture de l'essai : OUVERT

MAJ : 24/12/2018

Centre investigateur :
Centre Oscar Lambret - 3 Rue Frédéric Combemale - 59000 LILLE

Investigateur :
Docteur Xavier MIRABEL

TEC / ARC / IDE :
Unité Intégrée de Recherche Clinique
investigation@
o-lambret.fr
03.20.29.59.35

Ouverture de l'essai : OUVERT

MAJ : 19/02/2019