Digestive System DiseaseEPODIG-GNCT05066139
Multidisciplinary Evaluation of Elderly Patients With Digestive Cancer (EPODIG-G)
A study testing EPODIG-G program (coordination of supportive care) in people with Digestive System Disease and Neoplasms, run by Centre Paul Strauss at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Digestive System Disease, Neoplasms
- What is being tested?
- EPODIG-G program (coordination of supportive care)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteFrance
- Study dates
- 17 Sep 2021to 17 Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut de cancérologie Strasbourg Europe
Strasbourg, 67033
Valérie SARTORI, 368767223 ext. 33, v.sartori@icans.eu
Manon VOEGELIN, PhD, 368767360 ext. 33, promotion-rc@icans.eu
About this study
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)
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.
Read the 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.
- Conditions
- Digestive System Disease, Neoplasms
- Being tested
- EPODIG-G program (coordination of supportive care)
- Keywords
- Digestive cancer, supportive care, gastrointestinal cancer
- Medical subject headings
- Digestive System Diseases, Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Arm A Standard of care | No intervention | 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. |
| Arm B Multidisciplinary EPODIG program | Experimental | Patients will undergo the same geriatric assessment as in Arm A plus EPODIG-G program before treatment initiation. Receives: Other: EPODIG-G program (coordination of supportive care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of EPODIG-G program on treatment.
Number of patients who benefit from all programmed treatment cycles at 24 weeks
Measured: 24 weeks after treatment initiation
Secondary outcomes (4)
Dose-intensity evaluation. Cumulative doses and theoretical doses of chemotherapy or targeted therapy.
Measured: 24 weeks after treatment initiation
Number of adverse events and serious adverse events according to CTCAE v5.0.
Measured: throughout treatment, at 8, 16 and 24 weeks after treatment initiation
Progression free survival
Measured: 3 years after last inclusion
Overall survival
Measured: 3 years after last inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start17 Sep 2021
- Primary completion17 Oct 2030 (estimated)
- Study completion17 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive System DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Paul Strauss
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066139
- Sponsor's protocol ID
- 2020-018
- Other IDs
- 2021-A00956-35
- Acronym
- EPODIG-G
- Status last verified
- Dec 2025
- First submitted
- 23 Sep 2021
- Last updated
- 5 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05066139
- Acronym / sponsor ID
- EPODIG-G / 2020-018
- Conditions
- Digestive System Disease, Neoplasms
- Keywords
- Digestive cancer, supportive care, gastrointestinal cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Centre Paul StraussUniversity, hospital or other
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 17 Oct 2030 (estimated)
- Study completion
- 17 Oct 2030 (estimated)
- First posted
- 4 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A Standard of care | No intervention | –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. |
| Arm B Multidisciplinary EPODIG program | Experimental | Other: EPODIG-G program (coordination of supportive care)Patients will undergo the same geriatric assessment as in Arm A plus EPODIG-G program before treatment initiation. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Other | Arm B Multidisciplinary EPODIG program |
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPODIG-G program (coordination of supportive care) in people with Digestive System Disease and Neoplasms, run by Centre Paul Strauss at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valérie SARTORI (368767223 ext. 33, v.sartori@icans.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of EPODIG-G program on treatment. (time frame: 24 weeks after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.