Benefit of Chemotherapy Over Best Supportive Care in Metastatic and Squamous Cell-type Esophageal Cancer.

Conditions

Squamous Cell Carcinoma of Esophagus

Keywords

Chemotherapy, Best Supportive Care

Brief summary

Interest of continuing systemic chemotherapy or not , after a short initial treatment (6 weeks) in patients who are in response or stable disease(Discontinuation design )of patients with metastatic oesophageal cancer of squamous cell type The secondary aims would be to study : toxicity, the overall survival rate, a study of costs and quality of life.

Detailed description

As the data in litterature does not provide the basis for well-argued statistical hypothesis, it is suggested to randomize 30 patients per arm. An IDMC will come to a decision after the inclusion of 10, 20 ans 40 patients on the efficacy and the toxicity profile and on whether to maintain the current clinical position, justifying randomisation . In order to take into account any possible effects of prior concomitant radiochemotherapy, patient will be stratified according to whether they have already undergone chemotherapy or radiochemotherapy.

Marguet S, Adenis A, Delaine-Clisant S, Penel N, Bonastre J.

2021-03-268 citations

10.1016/j.jval.2020.11.017

Discontinuation of first-line chemotherapy (CT) after 6 weeks of CT in patients (pts) with metastatic squamous-cell esophageal cancer (MSEC): A randomized phase II trial.

Antoine Adenis, Jaafar Bennouna, Pierre-Luc Etienne, Emilie Bogart, Éric François et al. (20 authors)

Journal of Clinical Oncology2016-05-201 citations

10.1200/jco.2016.34.15_suppl.4002

First-Line Chemotherapy for Metastatic Esophageal Squamous Cell Carcinoma: Clinico-Biological Predictors of Disease Control.

Kotecki N, Hiret S, Etienne PL, Penel N, Tresch E, François E, Galais MP, Ben Abdelghani M, Michel P, Dahan L, Ghiringelli F, Bedenne L, Samalin E, Piessen G, Bennouna J, Peugniez C, El Hajbi F, Clisant S, Kramar A, Mariette C, Adenis A.

2016-01-202 citations

10.1159/000442947

Predictors of disease control in patients treated with platinum-based chemotherapies for metastatic squamous-cell esophageal cancer: First results of the e-DIS trial.

Antoine Adenis, Jaafar Bennouna, Marie‐Pierre Galais, Emmanuelle Tresch, Éric François et al. (20 authors)

Journal of Clinical Oncology2014-01-20

10.1200/jco.2014.32.3_suppl.95

Interventions

DRUGFU-CDDP

every 21 days: * Fluoro-uracil \[800 mg/m2, day 1 to day 5\] * CisPlatin \[75 mg/m2, day 1 or day 2\]

DRUGLV5FU2-CDDP

every 14 days: * Elvorin \[200 mg/m2, 2h IV, day 1 and day 2\] * Fluoro-uracil \[400 mg/m2 as a bolus, day 1 and day 2\] * Fluoro-uracil \[600 mg/m2, 22h continous infusion, day 1 and day 2\] * CisPlatin \[50 mg/m2, day 2\]

DRUGFOLFOX

every 14 days: * Oxaliplatin \[85 mg/m2 by 2h infusion, day 1\] * Fluoro-uracil \[400 mg/m2 as a bolus, day 1 and day 2\] * Fluoro-uracil \[600 mg/m2, by 22h continous infusion, day 1 and day 2\] * Elvorin \[500 mg/m2, day 1 and day 2\]

DRUGTPF

every 21 days: * Docetaxel \[30 mg/m2, day 1 and day 8\] * CisPlatin \[60 mg/m2, day 1\] * Fluoro-uracil \[200 mg/m2/day by continous infusion\] Or every 21 days: * Docetaxel \[50 mg/m2, day 1\] * CisPlatine \[70 mg/m2, day 1\] * Fluoro-uracile \[700 mg/m2 /day, day 1 to day 5\]

OTHERBest Supportive Care

See European professionnal recommendations (ESMO 2009) Exemples : antalgic treatment, nutritional support, ...

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Patients with an histologically proven epidermoid cancer of the oesophagus * Patients with metastatic disease that can be measured or evaluated according to the RECIST criteria, and located outside of previously irradiated fields * Patients who may or may not have undergone radiochemotherapy * Patients who have not received chemotherapy for metastatic disease * ≥ 18 ans * Performance Status (ECOG) ≤ 2 * People who are covered by private or state health insurance * Informed consent signed by the patient

Exclusion criteria

* Other evolutive malignant tumor * Infection with HIV-1, HIV-2 or chronic hepatitis B or C * Cerebral metastasis or known meningeal tumor * Any unstable chronic diseases that could risk the safety or the compliance of te patient * Women who are pregnant or breastfeeding. Women must not breastfeed for at least 6 months after administration of Bevacizumab * Patients unable to undergo the follow-up of the trial for geographical, social or psychological reasons For the randomized part Inclusion criteria : * Non-progressive disease after the 6 first weeks of chemotherapy * Performance Status (ECOG) ≤ 2

Design outcomes

Primary

Measure	Time frame
Overall survival	Between the date of randomisation and the date of death

Secondary

Measure	Time frame	Description
Progression free survival	Between the date of randomisation and the date of progression	—
Tolerance	At each visit : every 6 weeks	According to the NCI-CTCAE V4.0 grading scale
Quality of life by QLQ-C30	Every 6 weeks	EOTRC QLQ-C30 questionnaire and the oesophagus QLQ-OES18 module EQ-5D questionnaire
Cost analysis	Every 6 weeks	Data collected : * Hospitalization * day hospital visit * Chemotherapy drugs administered * Home medical care * Radiotherapy * Oncologist visits, General Practitioner Visits * Laboratory and radiologic tests

Countries

France

Outcome results

None listed