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

Esophageal Cancer, Squamous Cell Clinical Trial

— E-DIS2  

Official title:

Phase II Randomized Study Measuring the Interest of Pursuing or Not the CT for Non-progressive Patients With Metastatic Esophageal Squamous-cell Cancer After 6 Weeks of LV5FU2-paclitaxel Given After a 1st Line Fluoropyrimidine/Pt Salt CT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03301454
• Other study ID #: E-DIS2-1705
• Secondary ID: 2017-003660-1317
• Status: Recruiting
• Phase: Phase 2
• Start date: September 2018
• Est. completion date: February 2022

Study information

• Verified date: August 2018
• Source: Centre Oscar Lambret
• Contact: Marie VANSEYMORTIER
• Phone: 33320295918
• Email: promotion[@]o-lambret.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Esophageal Cancer, Squamous Cell
• Esophageal Neoplasms
• Neoplasms, Squamous Cell

Intervention

Drug:
• 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

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire	Amiens
France	Centre Paul Papin	Angers
France	Centre François Baclesse	Caen
France	Centre Oscar Lambret	Lille
France	Centre René Gauducheau	Nantes
France	Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie	Plérin
France	Centre Eugène Marquis	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimate the overall survival for patients suffering from Esophageal cancer	Non-progressive disease at and after 6 weeks of treatment until progression	From date of randomization until the date of death from any cause, up to 8 months after the beginning of the treatment
Secondary	Estimate efficiency in term of overall survival, of pursuing chemotherapy	beyond 6 weeks of treatment compared to a group that interrupted the treatment at 6 weeks	From date of randomization until the date of death from any cause, up to 8 months after the beginning of the treatment
Secondary	Estimate the efficiency in term of progression-free of pursuing chemotherapy	beyond 6 weeks of treatment	From date of randomization until the date of first documented progression or date of death from any cause, up to 8 months after the beginning of the treatment
Secondary	Estimate the rate of non progressive patients	after the 6 firsts weeks of treatment	From date of inclusion until the date of the end the 6 firsts weeks of treatment
Secondary	Estimate the overall survival of the whole study population	beyond the inclusion	From date of inclusion until the date of death from any cause, up to 8 months after the beginning of the treatment
Secondary	Measure the toxicity of chemotherapy	during the initial treatment phase compared to the 2 treatment arms after randomization	from baseline up to 12 months
Secondary	Estimate the consequences of pursuing chemotherapy	beyond 6 weeks of treatment in term of time until degradation of life quality and in term of overall benefits	From date of randomization until the date of first documented progression or date of death from any cause, up to 8 months after the beginning of the treatment