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

Squamous Cell Carcinoma of Esophagus Clinical Trial

— E-DIS  

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 .

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01248299
• Other study ID #: E-DIS 2010-06
• Secondary ID: 2010-021439-16
• Status: Terminated
• Phase: Phase 2
• Start date: January 2011
• Est. completion date: January 2017

Study information

• Verified date: May 2019
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 105
• Est. completion date: January 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Esophagus

Intervention

Drug:
• FU-CDDP
every 21 days: Fluoro-uracil [800 mg/m2, day 1 to day 5] CisPlatin [75 mg/m2, day 1 or day 2]
• LV5FU2-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]
• FOLFOX
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]
• TPF
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]

Other:
• Best Supportive Care
See European professionnal recommendations (ESMO 2009) Exemples : antalgic treatment, nutritional support, ...

Locations

Country	Name	City	State
France	CHU Brest	Brest
France	Centre François BACLESSE	Caen
France	Centre Georges François Leclerc	Dijon
France	CHU Dijon	Dijon
France	Centre Oscar Lambret	Lille
France	CHU Lille	Lille
France	CHU La Timone	Marseille
France	Centre Val d'Aurelle	Montpellier
France	Centre Antoine Lacassagne	Nice
France	Centre Eugène Marquis	Rennes
France	Clinique de la Theuillerie	Ris Orangis
France	CHU Rouen	Rouen
France	Centre René Gauducheau	Saint-Herblain
France	Clinique de l'Armoricaine	St-Brieuc
France	Centre Paul Strauss	Strasbourg
France	Centre Alexis Vautrin	Vandoeuvre-les-nancy
France	Centre Hospitalier Intercommunal	Villeneuve St Georges

Sponsors (2)

Lead Sponsor	Collaborator
Centre Oscar Lambret	National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

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