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Multidisciplinary Evaluation of Elderly Patients With Digestive Cancer (EPODIG-G) (EPODIG-G)

Primary Purpose

Digestive System Disease, Neoplasms

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

EPODIG-G program (coordination of supportive care)

About this trial

This is an interventional supportive care trial for Digestive System Disease focused on measuring Digestive cancer, supportive care, gastrointestinal cancer

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients must be ≥ 75 years old
Performance status 0, 1 or 2
Diagnostic of digestive cancer, all stages (adjuvant or metastatic), with an indication for chemotherapy treatment or targeted therapy
Patients previously treated with one or several lines of chemotherapy for this digestive cancer are eligible
Estimated life expectancy ≥ 3 months
Patients able to speak, read and understand French
Signed informed consent from the patient
Patients must have a social security coverage

Exclusion Criteria:

History of differentiated neuroendocrine tumors grade 1 or 2 (pancreas, small intestine)
History of another treated cancer during the last five years
History of major surgery and/or curative radiation therapy during the last 4 weeks before inclusion
Patients unable to submit to medical follow-up for geographical, social or psychological reasons
Patients placed under guardianship

Sites / Locations

Institut de cancérologie Strasbourg EuropeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Arm A Standard of care

Arm B Multidisciplinary EPODIG program

Arm Description

Patients will receive standard care before treatment initiation (i.e. geriatric assessment only). Geriatric assessment includes: Mini Mental State Examination ; mini-Geriatric Depression Scale (mini-GDS) ; Body Mass Index (BMI) calculation ; Mini Nutritional Assessment (MNA) ; Time up and Go ; Cumulative Illness Rating Scale - Geriatric (CIRS-G) ; Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) questionnaires.

Patients will undergo the same geriatric assessment as in Arm A plus EPODIG-G program before treatment initiation.

Outcomes

Primary Outcome Measures

Impact of EPODIG-G program on treatment.

Number of patients who benefit from all programmed treatment cycles at 24 weeks

Secondary Outcome Measures

Dose-intensity evaluation. Cumulative doses and theoretical doses of chemotherapy or targeted therapy.

Number of adverse events and serious adverse events according to CTCAE v5.0.

Progression free survival

Overall survival

Full Information

NCT ID

NCT05066139

First Posted

September 23, 2021

Last Updated

November 23, 2022

Sponsor

Institut de cancérologie Strasbourg Europe

1. Study Identification

Unique Protocol Identification Number

NCT05066139

Brief Title

Multidisciplinary Evaluation of Elderly Patients With Digestive Cancer (EPODIG-G)

Acronym

EPODIG-G

Official Title

Monocentric Randomized Study Evaluating the Impact of an Early Multidisciplinary Program in Elderly Subjects Starting a Chemotherapy for Digestive Cancer: Multidisciplinary Evaluation of Elderly Patients With Digestive Cancer (EPODIG-G)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 17, 2021 (Actual)

Primary Completion Date

March 17, 2024 (Anticipated)

Study Completion Date

September 17, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut de cancérologie Strasbourg Europe

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This is a monocentric, comparative, open-label, randomized parallel group study enrolling elderly subjects hospitalized in Strasbourg Europe Cancerology Institute (ICANS), starting chemotherapy or targeted therapy for the treatment of digestive cancer.

Detailed Description

At the ICANS an EPODIG-G program, consisting in a coordination of supportive care that are existing in the Institute, is proposed to elderly patients with digestive cancer. The purpose of this study is to evaluate the impact of this early multidisciplinary geriatric program (EPODIG-G), when it is initiated before therapeutic treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Digestive System Disease, Neoplasms

Keywords

Digestive cancer, supportive care, gastrointestinal cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A Standard of care

Arm Type

No Intervention

Arm Description

Arm Title

Arm B Multidisciplinary EPODIG program

Arm Type

Experimental

Arm Description

Patients will undergo the same geriatric assessment as in Arm A plus EPODIG-G program before treatment initiation.

Intervention Type

Other

Intervention Name(s)

EPODIG-G program (coordination of supportive care)

Intervention Description

EPODIG-G program includes: a nutritional evaluation (laboratory tests: albumin, pre-albumin, C reactive protein and vitamin D dosage, nutritional status, Handgrip test, Simple Evaluation of Food Intake (SEFI), spontaneous food intake evaluation) ; a medication reconciliation ; physical therapy (Six Minute Walk Test)

Primary Outcome Measure Information:

Title

Impact of EPODIG-G program on treatment.

Description

Number of patients who benefit from all programmed treatment cycles at 24 weeks

Time Frame

24 weeks after treatment initiation

Secondary Outcome Measure Information:

Title

Dose-intensity evaluation. Cumulative doses and theoretical doses of chemotherapy or targeted therapy.

Time Frame

24 weeks after treatment initiation

Title

Number of adverse events and serious adverse events according to CTCAE v5.0.

Time Frame

throughout treatment, at 8, 16 and 24 weeks after treatment initiation

Title

Progression free survival

Time Frame

3 years after last inclusion

Title

Overall survival

Time Frame

3 years after last inclusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must be ≥ 75 years old Performance status 0, 1 or 2 Diagnostic of digestive cancer, all stages (adjuvant or metastatic), with an indication for chemotherapy treatment or targeted therapy Patients previously treated with one or several lines of chemotherapy for this digestive cancer are eligible Estimated life expectancy ≥ 3 months Patients able to speak, read and understand French Signed informed consent from the patient Patients must have a social security coverage Exclusion Criteria: History of differentiated neuroendocrine tumors grade 1 or 2 (pancreas, small intestine) History of another treated cancer during the last five years History of major surgery and/or curative radiation therapy during the last 4 weeks before inclusion Patients unable to submit to medical follow-up for geographical, social or psychological reasons Patients placed under guardianship

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Valérie SARTORI

Phone

368767223

Ext

v.sartori@icans.eu

First Name & Middle Initial & Last Name or Official Title & Degree

Manon VOEGELIN

Phone

368767360

Ext

promotion-rc@icans.eu

Facility Information:

Facility Name

Institut de cancérologie Strasbourg Europe

City

Strasbourg

ZIP/Postal Code

67033

Country

France

Individual Site Status

Recruiting

Facility Contact: