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Chemoradiotherapy in Elderly Patients With Oesophagus Cancer

ConditionsOesophagus CancerElderly Patients
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age75-100
SponsorCentre Hospitalier Universitaire de Besancon

About this trial

Management of elderly patient with cancer is a therapeutic challenge and a public health problem. The mean age of esophageal cancer is 64.5 years and 72.1 years in men and women respectively. Surgery is a standard treatment reserved to about 30 % of patients. The other 70 % are considered unfit for surgery for various reasons, including ageing.

Chemoradiotherapy (CRT) is standard treatment for patients with esophageal cancer unfit for surgery. The validated treatment scheme is external beam radiotherapy (EBRT) 50 Gy over 5 weeks combined with cisplatin and 5FU infusion. However it induces high rates of severe and life threatening toxicities: grade 3 haematologic and esophageal mucositis of 20 and 25 % respectively, in patients with a median age of 64 years. CRT has not been properly evaluated in patients more than 75 years, and other combined chemotherapy are challenging.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Esophageal cancer, squamous and adenocarcinoma types, T1-3, N0-1, M1a (TNM 6th),

age > 75 years,

WHO status < 2, Balducci 1, adequate bone marrow reserve, normal renal and hepatic function.

Disqualifiers

age < 75 years

Trial design

Design model

Single group

Treatments tested in this trial

  • Carboplatin

    Drug

Treatment groups

54 Participants
are divided into 1 treatment group
Group A: Phase IExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

maximum tolerated dose (MTD)

the objective is to determine the maximum tolerated dose (MTD) and recommended doses for phase II.The phase I is conducted with increasing doses of each component with 9 levels.Step definitively stopped in case of any grade ≥ 3 or severe acute toxicities. In case a step is definitively stopped, add 3 more patients to the precedent step. Quality assurance

Time frame
1 months after the end of the treatment

Secondary outcomes

1

Quality of life

EORTC QLQ-C30,

Time frame
3 years
2

Quality of life

ELD14

Time frame
3 years
3

progression free survival

Time frame
3 years
4

overall survival

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire de Besancon

Lead sponsor

Source ClinicalTrials.gov
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