Radiochemotherapy in Elderly Patients With Oesophagus Cancer

Esophagus Cancer Clinical Trial

— Chronos  

Official title:

Phase II of Radiochemotherapy in Elderly Patients With Oesophagus Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02879227
• Other study ID #: P/2009/79
• Status: Completed
• Phase: Phase 2
• First received: August 3, 2016
• Last updated: August 22, 2016
• Start date: January 2010
• Est. completion date: December 2014

Study information

• Verified date: August 2016
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Phase II study of radiochemotherapy for elderly patients with oesophagus cancer.

Description:

Phase II study of radiochemotherapy for elderly patients with oesophagus cancer with Radiotherapy = 50 Gy, 2Gy/f ans chemotherapy with 2 arms arm Cisplatin = Cisplatin 75mg/m2 J1J22 or arm Oxaliplatine = oxaliplatine 85mg/m2 every 2 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• patients aged 75 or more with oesophagus cancer (squamous or adenocarcinoma), fit to treat

Exclusion Criteria:

• previous radiotherapy

• no fit to treat

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Esophagus Cancer

Intervention

Drug:
• Cisplatin
Arm cisplatin : 75mg/m2, day n*1 and day n*22, And radiotherapy 50 Gy, 2Gy/f
• Oxaliplatin
85 mg/m2 every 2 weeks, 6 times And radiotherapy 50 Gy, 2Gy/f

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

References & Publications (2)

Servagi-Vernat S, Bosset M, Crehange G, Buffet-Miny J, Puyraveau M, Maingon P, Mercier M, Bosset JF. Feasibility of chemoradiotherapy for oesophageal cancer in elderly patients aged >or=75 years: a prospective, single-arm phase II study. Drugs Aging. 2009;26(3):255-62. doi: 10.2165/00002512-200926030-00006. — View Citation

Servagi-Vernat S, Créhange G, Roullet B, Guimas V, Maingon P, Puyraveau M, Bosset JF. Phase II Study of a Platinum-Based Adapted Chemotherapy Regimen Combined with Radiotherapy in Patients 75 Years and Older with Esophageal Cancer. Drugs Aging. 2015 Jun;3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of treatment: Number of patients with completed treatment	number of patient with completed treatment	6 weeks after end of the radiochemotherapy	Yes
Secondary	Tumoral response	tumoral evaluation at 6 weeks after the treatment	6 weeks after end of the radiochemotherapy	Yes
Secondary	Quality of life	QLQC30	6 weeks after end of the radiochemotherapy	Yes
Secondary	Quality of life	ELD14	6 weeks after end of the radiochemotherapy	Yes