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NCT Number: NCT05066139

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

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.

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Key information

Conditions

Digestive System Disease Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de cancérologie Strasbourg Europe

Strasbourg, 67033, France

Location status: Recruiting

Location contact

Damien HEITZ, MD

SUB_INVESTIGATOR

Manon VOEGELIN, PhD

CONTACT

[email protected]

368767360 ext. 33

Meher BEN ABDELGHANI, MD

PRINCIPAL_INVESTIGATOR

Pascale CHIAPPA, MD

SUB_INVESTIGATOR

Valérie SARTORI

CONTACT

[email protected]

368767223 ext. 33

Virginie LEROY, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EPODIG-G program (coordination of supportive care)

Other

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 outcomes

  1. Impact of EPODIG-G program on treatment.

    Time frame: 24 weeks after treatment initiation

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

Secondary outcomes

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

    Time frame: 24 weeks after treatment initiation

  2. 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

  3. Progression free survival

    Time frame: 3 years after last inclusion

  4. Overall survival

    Time frame: 3 years after last inclusion

Study contacts

Contact information is provided by the study sponsor or research team.

Manon VOEGELIN

CONTACT

[email protected]

368767360 ext. 33

Valérie SARTORI

CONTACT

[email protected]

368767223 ext. 33

Sponsors and collaborators

Lead sponsor

Centre Paul Strauss

Other

Registry information

Official study 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)

Acronym: EPODIG-G

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
Oct 4, 2021
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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