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Completed

NCT Number: NCT02879227

Radiochemotherapy in Elderly Patients With Oesophagus Cancer

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

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Key information

Conditions

Esophagus Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • previous radiotherapy
  • no fit to treat

Treatment and study plan

Cisplatin

Drug

Arm cisplatin : 75mg/m2, day n*1 and day n*22, And radiotherapy 50 Gy, 2Gy/f

Other names: Arm Cisplatin

Oxaliplatin

Drug

85 mg/m2 every 2 weeks, 6 times And radiotherapy 50 Gy, 2Gy/f

Other names: Arm Oxaliplatin

Primary outcomes

  1. Feasibility of treatment: Number of patients with completed treatment

    Time frame: 6 weeks after end of the radiochemotherapy

    number of patient with completed treatment

Secondary outcomes

  1. Tumoral response

    Time frame: 6 weeks after end of the radiochemotherapy

    tumoral evaluation at 6 weeks after the treatment

  2. Quality of life

    Time frame: 6 weeks after end of the radiochemotherapy

    QLQC30

  3. Quality of life

    Time frame: 6 weeks after end of the radiochemotherapy

    ELD14

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

Phase II of Radiochemotherapy in Elderly Patients With Oesophagus Cancer

Acronym: Chronos

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Aug 25, 2016
Registry last updated
Aug 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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