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Chemoradiotherapy in Elderly Patients With Oesophagus Cancer (OSAGE)

This study is currently recruiting participants.
Verified April 2017 by Stéphanie Servagi-Vernat, MD, PhD, Centre Hospitalier Universitaire de Besancon
Sponsor:
ClinicalTrials.gov Identifier:
NCT02735057
First Posted: April 12, 2016
Last Update Posted: April 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Stéphanie Servagi-Vernat, MD, PhD, Centre Hospitalier Universitaire de Besancon
  Purpose

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.


Condition Intervention Phase
Oesophagus Cancer Elderly Patients Drug: Carboplatin Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I-II Study Chemoradiation in Elderly Patients With Oesophagus Cancer

Resource links provided by NLM:


Further study details as provided by Stéphanie Servagi-Vernat, MD, PhD, Centre Hospitalier Universitaire de Besancon:

Primary Outcome Measures:
  • maximum tolerated dose (MTD) [ Time Frame: 1 months after the end of the treatment ]

    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



Secondary Outcome Measures:
  • Quality of life [ Time Frame: 3 years ]
    EORTC QLQ-C30,

  • Quality of life [ Time Frame: 3 years ]
    ELD14

  • progression free survival [ Time Frame: 3 years ]
  • overall survival [ Time Frame: 3 years ]

Estimated Enrollment: 54
Actual Study Start Date: April 2016
Estimated Study Completion Date: April 2024
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase I
  • for chemotherapy 3 levels: 50%, 75% and 100% of the standard Dutch dose (carboplatin AUC 2 and paclitaxel 50 mg/m2)
  • for radiotherapy 3 levels: 41.4 Gy/1.8 Gy/f; 45 Gy/1.8 Gy/f; 50.4 Gy/1.8 Gy/f basel level being : 41.4 Gy and 50% of standard CT doses The phase I is conducted with increasing doses of each component with 9 levels.
Drug: Carboplatin
Other Name: Paclitaxel

Detailed Description:

Choice of the combined chemotherapy Carboplatin and taxanes delivered concurrently to radiotherapy is attractive. A Dutch randomized study (Cross trial) compared preoperative CRT to surgery in 368 patients with T1-T3 and N0N1. In the preoperative CRT group, patients received 41.4 Gy by EBRT over 5 weeks combined with carboplatin (AUC 2) and paclitaxel (50 mg/m2). A 30 % tumor sterilization rate and a reduction of metastasis considered a distant effect of chemotherapy were observed. The 5-year survival was statistically better with CRT group. The preoperative CRT was well tolerated and few acute toxicities were observed. Intriguingly, in a French randomized study, conducted in less locally advanced disease, the combination of 45 Gy and 5 FU infusion and Cisplatin did not induce more tumor sterilization rate, suggesting carboplatine/paclitaxel is more effective than 5FU/cisplatin in CRT.

Study design Since the optimal doses of each component radiotherapy- carboplatin - paclitaxel are unknown, we plan to conduct a phase I/II study

  • Phase I: the objective is to determine the maximum tolerated dose (MTD) and recommended doses for phase II (RP2D) of each component considering the treatment scheme of Dutch study as reference:

    • for chemotherapy 3 levels: 50%, 75% and 100% of the standard Dutch dose (carboplatin AUC 2 and paclitaxel 50 mg/m2)
    • for radiotherapy 3 levels: 41.4 Gy/1.8 Gy/f; 45 Gy/1.8 Gy/f; 50.4 Gy/1.8 Gy/f basel level being : 41.4 Gy and 50% of standard CT doses The phase I is conducted with increasing doses of each component with 9 levels.
  • Phase II: after the determination of RP2D of each component, the study is continued as a phase II in order to assess tumor response Secondary objectives: Quality of life, progression free and overall survivals
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years to 100 Years   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • age < 75 years
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02735057


Contacts
Contact: Stéphanie SERVAGI-VERNAT, Dr 0689313545 stephanie.servagi@gmail.com

Locations
France
Centre Hospitalier Universitaire de Besançon Recruiting
Besancon, France, 25000
Contact: Sophie DEPIERRE       sdepierre@chu-besancon.fr   
Principal Investigator: Gilles CREHANGE, PU-PH         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
Study Chair: Sophie DEPIERRE Centre Hospitalier Universitaire de Besançon
  More Information

Responsible Party: Stéphanie Servagi-Vernat, MD, PhD, MD, PhD, Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02735057     History of Changes
Other Study ID Numbers: N/2014/68
First Submitted: March 18, 2016
First Posted: April 12, 2016
Last Update Posted: April 17, 2017
Last Verified: April 2017

Keywords provided by Stéphanie Servagi-Vernat, MD, PhD, Centre Hospitalier Universitaire de Besancon:
oesophagus cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action


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