NCT02735057

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
36mo left

Started Apr 2016

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Apr 2016May 2029

First Submitted

Initial submission to the registry

March 18, 2016

Completed
17 days until next milestone

Study Start

First participant enrolled

April 4, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
12.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2029

Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

12.6 years

First QC Date

March 18, 2016

Last Update Submit

January 17, 2024

Conditions

Oesophagus CancerElderly Patients

Keywords

oesophagus cancer

Outcome Measures

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

    1 months after the end of the treatment

Secondary Outcomes (4)

  • Quality of life

    3 years

  • Quality of life

    3 years

  • progression free survival

    3 years

  • overall survival

    3 years

Study Arms (1)

Phase I

EXPERIMENTAL

* 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

Interventions

CarboplatinDRUG
Also known as: Paclitaxel
Phase I

Eligibility Criteria

Age75 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • age \< 75 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Besançon

Besançon, 25000, France

RECRUITING

Related Publications (1)

  • Servagi-Vernat S, Crehange G, Bonnetain F, Mertens C, Brain E, Bosset JF. Chemoradiation in elderly esophageal cancer patients: rationale and design of a phase I/II multicenter study (OSAGE). BMC Cancer. 2017 Jul 13;17(1):483. doi: 10.1186/s12885-017-3465-4.

    PMID: 28705182DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

CarboplatinPaclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Central Study Contacts

Jihane BOUSTANI, Dr

CONTACT

jboustani@chu-besancon.fr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2016

First Posted

April 12, 2016

Study Start

April 4, 2016

Primary Completion (Estimated)

November 16, 2028

Study Completion (Estimated)

May 16, 2029

Last Updated

January 18, 2024

Record last verified: 2024-01

Locations

FR(1)