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

Sponsor
Institut de cancérologie Strasbourg Europe (Other)
Overall Status
Recruiting
CT.gov ID
NCT05066139
Collaborator
(none)
144
Enrollment
1
Location
2
Arms
60
Anticipated Duration (Months)
2.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: EPODIG-G program (coordination of supportive care)
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
144 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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)
Actual Study Start Date :
Sep 17, 2021
Anticipated Primary Completion Date :
Mar 17, 2024
Anticipated Study Completion Date :
Sep 17, 2026

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Arm A Standard of care

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.
Experimental: Arm B Multidisciplinary EPODIG program

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

Other: EPODIG-G program (coordination of supportive care)
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)

Outcome Measures

Primary Outcome Measures

  1. Impact of EPODIG-G program on treatment. [24 weeks after treatment initiation]

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

Secondary Outcome Measures

  1. Dose-intensity evaluation. Cumulative doses and theoretical doses of chemotherapy or targeted therapy. [24 weeks after treatment initiation]

  2. Number of adverse events and serious adverse events according to CTCAE v5.0. [throughout treatment, at 8, 16 and 24 weeks after treatment initiation]

  3. Progression free survival [3 years after last inclusion]

  4. Overall survival [3 years after last inclusion]

Eligibility Criteria

Criteria

Ages Eligible for Study:
75 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut de cancérologie Strasbourg Europe Strasbourg France 67033

Sponsors and Collaborators

  • Institut de cancérologie Strasbourg Europe

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut de cancérologie Strasbourg Europe
ClinicalTrials.gov Identifier:
NCT05066139
Other Study ID Numbers:
  • 2020-018
  • 2021-A00956-35
First Posted:
Oct 4, 2021
Last Update Posted:
Oct 11, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Institut de cancérologie Strasbourg Europe
Digestive cancer
supportive care
gastrointestinal cancer
Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases

Study Results

No Results Posted as of Oct 11, 2021