Study of the Interest of Pursuing or Not the Chemotherapy for Patients With Metastatic Esophageal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-30

Study Completion Date

2022-02-28

Brief Summary

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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

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Detailed Description

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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

Conditions

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Esophageal Cancer, Squamous Cell

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Pursuit of chemotherapy.

Group Type EXPERIMENTAL

pursuit of chemotherapy

Intervention Type DRUG

Treatment with LV5FU2 (5-FU, Calcium Levofolinate) - paclitaxel, regular tumor evaluation, best supportive care Other authorized treatment : usual paclitaxel pre-treatment consisting of Dexamethasone, Chlorpheniramine and ranitidine, at 15 and 1 day before the actual paclitaxel treatment

Arm B

Interruption of chemotherapy, best supportive care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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pursuit of chemotherapy

Treatment with LV5FU2 (5-FU, Calcium Levofolinate) - paclitaxel, regular tumor evaluation, best supportive care Other authorized treatment : usual paclitaxel pre-treatment consisting of Dexamethasone, Chlorpheniramine and ranitidine, at 15 and 1 day before the actual paclitaxel treatment

Intervention Type DRUG

Other Intervention Names

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LV5FU2-paclitaxel CT

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Farid EL HAJBI, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Oscar Lambret

Locations

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