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

Phase 2

Terminated

• Conditions: Squamous Cell Carcinoma of Esophagus
• Interventions: Drug: FU-CDDP; Other: Best Supportive Care; Drug: LV5FU2-CDDP; Drug: FOLFOX; Drug: TPF

• Registration Number: NCT01248299
• Lead Sponsor: Centre Oscar Lambret

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.

Study Timeline

• Study First Submitted: 2010-11-24
• Study First Submitted QC: 2010-11-24
• Study First Posted: 2010-11-25
• Study Start: 2011-01
• Primary Completion: 2016-01
• Study Completion: 2017-01
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-14
• Last Update Posted: 2019-05-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemotherapy plus best supportive care	TPF	Chemotherapy plus best supportive care with follow up at each cycle of the treatment with FU-CDDP; LV5FU2-CDDP; FOLFOX; TPF
Chemotherapy plus best supportive care	LV5FU2-CDDP	Chemotherapy plus best supportive care with follow up at each cycle of the treatment with FU-CDDP; LV5FU2-CDDP; FOLFOX; TPF
Chemotherapy plus best supportive care	FOLFOX	Chemotherapy plus best supportive care with follow up at each cycle of the treatment with FU-CDDP; LV5FU2-CDDP; FOLFOX; TPF
Chemotherapy plus best supportive care	FU-CDDP	Chemotherapy plus best supportive care with follow up at each cycle of the treatment with FU-CDDP; LV5FU2-CDDP; FOLFOX; TPF
Best supportive care	Best Supportive Care	Best supportive care with follow up every 6 weeks

Primary Outcome Measures

Name	Time	Method
Overall survival	Between the date of randomisation and the date of death

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (17)

CHU Brest; 🇫🇷 Brest, France

Centre Georges François Leclerc; 🇫🇷 Dijon, France

Centre François BACLESSE; 🇫🇷 Caen, France

Centre Oscar Lambret; 🇫🇷 Lille, France

CHU Dijon; 🇫🇷 Dijon, France

CHU Lille; 🇫🇷 Lille, France

Centre Val d'Aurelle; 🇫🇷 Montpellier, France

CHU La Timone; 🇫🇷 Marseille, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Centre Eugène Marquis; 🇫🇷 Rennes, France

Clinique de la Theuillerie; 🇫🇷 Ris Orangis, France

Centre Alexis Vautrin; 🇫🇷 Vandoeuvre-les-nancy, France

Clinique de l'Armoricaine; 🇫🇷 St-Brieuc, France

Centre Hospitalier Intercommunal; 🇫🇷 Villeneuve St Georges, France

CHU Rouen; 🇫🇷 Rouen, France

Centre René Gauducheau; 🇫🇷 Saint-Herblain, France

Centre Paul Strauss; 🇫🇷 Strasbourg, France