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Recruiting NCT05066139

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

No phase Interventional Digestive System Disease Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EPODIG-G program (coordination of supportive care).
Who it may be relevant to
Registry conditions: Digestive System Disease, Neoplasms. Basic parameters: from 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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)

Overview

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.

Interventions

  • 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)

Primary outcome measures

  • Impact of EPODIG-G program on treatment. [Time frame: 24 weeks after treatment initiation]
Secondary outcome measures (4)
  • Dose-intensity evaluation. Cumulative doses and theoretical doses of chemotherapy or targeted therapy. [Time frame: 24 weeks after treatment initiation]
  • 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]
  • Progression free survival [Time frame: 3 years after last inclusion]
  • Overall survival [Time frame: 3 years after last inclusion]

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 for a treatment period of 24 weeks or more
  • 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)
  • Cancer currently being treated (except for hormone therapy) other than current digestive cancer
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 1 center
  • Institut de cancérologie Strasbourg Europe — Strasbourg

Identifiers

NCT: NCT05066139 · 2020-018 · 2021-A00956-35

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗