Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-24 @ 9:30 PM
NCT ID:
NCT02704832
Eligibility Criteria:
Inclusion Criteria:
1. Patient older 70 years and older
2. Performance status 0 to 3 (WHO)
3. G8 and QLQ-C30 questionnaires 'score are available
4. No previous geriatric evaluation during cancer treatment
5. Locally advanced or metastatic disease :
1. 1st line medical treatment :
* Breast cancer : locally advanced or metastatic disease, hormone-resistant and Her2 negative,
* Colon and rectum : metastatic (unresectable metastasis),
* Prostate cancer : metastatic and refractory to hormonal castration,
* Bladder cancer : locally advanced or metastatic,
* Ovarian cancer : advanced stage (IIb to IV),
* Lung cancer : metastatic non-small cell,
* Lymphomas (indolent and aggressive)
2. Or 2nd line medical treatment :
* Breast cancer : locally advanced or metastatic disease, hormone-resistant and Her2 negative,
* Colon and rectum : metastatic (unresectable metastasis),
* Prostate cancer : metastatic and refractory to hormonal castration,
* Ovarian cancer : advanced stage (IIb to IV),
* Lymphomas (indolent and aggressive)
6. Life expectancy over 6 months
7. Signed informed consent
8. Patients with a French social security in compliance with the French law relating to biomedical research (Article L.1121-11 of French Public Health Code).
Exclusion Criteria:
1. Patient who already received 2 medical treatment lines
2. Exclusive 1st or 2nd treatment lines of :
* Hormonotherapy (except for prostate cancer : abiteratone acetate is allowed),
* Surgery,
* Radiotherapy,
3. "Best supportive care" treatment
4. Patient unable to understand quality of life questionnaire
5. Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons.
6. Patient placed under guardianship
7. Planned concomitant participation to another medical interventional trial during the 12 months following the inclusion in the randomized study PREPARE
8. Previous enrolment in the present study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT02704832
Study Brief:
Protocol Section:
NCT02704832