Chemoradiotherapy in Elderly Patients With Oesophagus Cancer (OSAGE)

January 17, 2024 updated by: Centre Hospitalier Universitaire de Besancon

Phase I-II Study Chemoradiation in Elderly Patients With Oesophagus Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Besancon, France, 25000
        • Recruiting
        • Centre Hospitalier Universitaire de Besancon
        • Principal Investigator:
          • Jihane BOUSTANI, PH
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years to 100 years (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 months after the end of the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 3 years
3 years
progression free survival
Time Frame: 3 years
3 years
Quality of life
Time Frame: 3 years
EORTC QLQ-C30,
3 years
Quality of life
Time Frame: 3 years
ELD14
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2016

Primary Completion (Estimated)

November 16, 2028

Study Completion (Estimated)

May 16, 2029

Study Registration Dates

First Submitted

March 18, 2016

First Submitted That Met QC Criteria

April 6, 2016

First Posted (Estimated)

April 12, 2016

Study Record Updates

Last Update Posted (Actual)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N/2014/68

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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