Study of the Interest of Pursuing or Not the Chemotherapy for Patients With Metastatic Esophageal Cancer (E-DIS2)

Centre Oscar Lambret

Status and phase

Unknown

Phase 2

Conditions

Esophageal Cancer, Squamous Cell

Treatments

Drug: pursuit of chemotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03301454

2017-003660-13 (EudraCT Number)

E-DIS2-1705

170757A-12 (Other Identifier)

Details and patient eligibility

About

Phase II study, randomized, open-label, multicentric, willing to establish the benefit of pursuing chemotherapy beyond 6 weeks for non progressive patients. The study will proceed in two successive phases :

non randomized phase in which all patients will undergo chemotherapy
second phase in which only non progressive patients are going to be randomized ("discontinuation design"). Patients that will show progression in their disease during the first 6 weeks will be released of the study

Full description

Initial phase: this part of the trial consist of 3 cycles of LV5FU2 (Bolus 5-FU 400mg/m² - 5-FU continuously during 46h: 3000 mg/m², calcium levofolinate 200 mg/m²) - paclitaxel (100 mg/m² at day 1) every 14 days. After 6 weeks,the phase will end with a check-up (clinical exam, tumor evaluation and biological test). Then, if the disease is non-progressive, the patient will proceed to the randomized phase.

Randomized phase:

Arm A : pursuit of chemotherapy and best supportive care
Arm B : interruption of chemotherapy and best supportive care

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients suffering from squamous-cell type esophageal cancer histologically proved
Metastatic disease measurable according to RECIST criteria. Patients with metachronous metastasis and who have been treated with surgery (+/- radio chemotherapy concurrent or adjuvant chemotherapy) or exclusive radio chemotherapy, are eligible
Patients who show progress under chemotherapy that associates a fluoropyrimidine with a platinum salt
Man or woman over 18 years old
ECOG performance status ≤ 2
Adequate haematological, renal and hepatic functions : PNN ≥ 1500/ mm3; platelets ≥ 100 000/ mm3; Haemoglobin ≥ 9.0 g/dL; ALT and AST ≤ 2.5 ULN (≤ 5.0 in case of liver metastases); Total bilirubin ≤ 1.5 X ULN; Serum creatinine ≤ 1.5 ULN
Efficient contraceptive method for both gender (if applicable), during the whole treatment period and the 6 months following the last treatment administration
Affiliation to the National Social Security System
With informed and signed consent

Inclusion Criteria for randomization:

ECOG performance status ≤ 2
Able to pursuit the LV5FU2-paclitaxel chemotherapy
Non-progressive disease after the initial phase (first tumor exam at week 6)

Exclusion criteria

Patients who received more than one line of chemotherapy for a metastatic disease
Presence of other evolutive tumors
Cerebral metastasis or other known brain tumors
Severe liver failure
Pernicious anemia or other anemia due to vitamin B12 defficiency
Hypersensibility to an active substance or any other excipients of experimental drugs
Every unstable chronicle diseases that can affect patient confidence or security
Clinically significant active cardiac disease or myocardial infarction in the 6 previous months
Patients with a known dihydropyrimidine dehydrogenase (DPD) deficiency
Concomitant treatment with : sorivudin or analogs; prophylactic phenytoin
Live attenuated vaccine within the 3 previous months
Pregnant or breastfeeding women
Unable to comply with the medical monitoring for geographic, social or mental issues
Patient Under guardianship or tutorship