Clinical trial NCT01248299: Benefit of Chemotherapy Over Best Supportive Care in Metastatic and Squamous Cell-type Esophageal Cancer.
Official title: A Multicenter Randomized Phase II Study to Evaluate the Benefit of Chemotherapy Plus Best Supportive Care (BSC) Versus BSC in Patients With Metastatic Oesophageal Cancer of Squamous Cell-type Who Have Not Experienced a Disease Progression or Unacceptable Toxicity After a 6-weeks Chemotherapy Course .
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Squamous Cell Carcinoma of Esophagus
Keywords: Chemotherapy
Best Supportive Care
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
First posted: 2010-11-25
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: Between the date of randomisation and the date of death
Secondary outcomes:
measure: Progression free survival
timeFrame: Between the date of randomisation and the date of progression
measure: Tolerance
timeFrame: At each visit : every 6 weeks
measure: Quality of life by QLQ-C30
timeFrame: Every 6 weeks
measure: Cost analysis
timeFrame: Every 6 weeks
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU Brest
city: Caen
country: France
facility: Centre François BACLESSE
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Dijon
country: France
facility: CHU Dijon
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lille
country: France
facility: CHU Lille
city: Marseille
country: France
facility: CHU La Timone
city: Montpellier
country: France
facility: Centre Val d'Aurelle
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Ris Orangis
country: France
facility: Clinique de la Theuillerie
city: Rouen
country: France
facility: CHU Rouen
city: Saint-Herblain
country: France
facility: Centre René Gauducheau
city: St-Brieuc
country: France
facility: Clinique de l'Armoricaine
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Vandoeuvre-les-nancy
country: France
facility: Centre Alexis Vautrin
city: Villeneuve St Georges
country: France
facility: Centre Hospitalier Intercommunal
Study officials:
affiliation: Centre Oscar Lambret
name: Antoine ADENIS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kotecki N, Hiret S, Etienne PL, Penel N, Tresch E, Francois 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. First-Line Chemotherapy for Metastatic Esophageal Squamous Cell Carcinoma: Clinico-Biological Predictors of Disease Control. Oncology. 2016;90(2):88-96. doi: 10.1159/000442947. Epub 2016 Jan 20.