Clinical trial · Interventional
Role of Geriatric Intervention in Treatment of Older Patients With Cancer (PREPARE)
Role of Geriatric Intervention in Treatment of Older Patients With Cancer : a Phase III Randomized Study (PREPARE)
NCT02704832CI-TRIAL-00102050PREPAREcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
Randomized trials have already demonstrated that geriatric intervention was able to improve survival in the general elderly population but only a few have been performed in cancer patients. At the end, these data are not sufficient to consider geriatric intervention as validated in this setting. Case Management, coordinated by a geriatrician and a trained nurse, could improve prognosis of elderly patients with cancer. This approach, can be integrated in daily oncology practice. This strategy will be compared to usual oncological management in a randomized phase III trial.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Geriatrician Intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Arm A
- description
- Arm A "Standard oncological care": patients will be treated according to daily oncological practices as defined for each type of cancer, in the "Management protocol of Oncology" written and validated by a group of expert oncologists. The quality of life will be assessed every 3 months during the first year and at 18 months. The study's follow-up will last until 3 years after the enrollment of the last patient and data on vital status of the patient, weight, place of life and the status of the disease will be collected every 6 months.
- type
- EXPERIMENTAL
- label
- Arm B
- description
- Arm B "Geriatrician Intervention": patients will be treated according to the same "Management protocol of Oncology" than patients in the arm "Standard oncological care". * Before the beginning of the medical treatment, a comprehensive geriatric assessment will be performed by the geriatrician and the nurse that will define a plan of geriatric management care, according to the "Management protocol of Geriatrics". * The nurse, under the supervision of a geriatrician, will monitor implemented geriatric interventions. Phone follow-up will be performed every month for 6 months and at 9 months or during any change of situation according to a pre-established phone call plan. A full geriatric assessment by the geriatrician and the nurse will be performed at 6 and 12 months.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
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 studyReferences
Publications (1)
- DERIVEDSoubeyran P, Terret C, Bellera C, Bonnetain F, Jean OS, Galvin A, Chakiba C, Zwolakowski MD, Mathoulin-Pelissier S, Rainfray M. Role of geriatric intervention in the treatment of older patients with cancer: rationale and design of a phase III multicenter trial. BMC Cancer. 2016 Dec 1;16(1):932. doi: 10.1186/s12885-016-2927-4. PMID 27908282