Status:
RECRUITING
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Lead Sponsor:
Institut Bergonié
Collaborating Sponsors:
EUCLID Clinical Trial Platform
University of Bordeaux
Conditions:
Breast Cancer
Comorbidities and Coexisting Conditions
Eligibility:
All Genders
70-130 years
Phase:
NA
Brief Summary
The primary objective of GERONTE STUDY is to evaluate the effectiveness of the GERONTE, ICT-based, integrated care pathway to improve patient 6-month quality of life, in France. Study design is a ste...
Detailed Description
This is a stepped wedge of cross-over type. Patients included at each "step" are different individuals. The first "step" is a reference measurement where none of the clusters will implement the interv...
Eligibility Criteria
Inclusion Criteria:
- General inclusion criteria
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Age ≥ 70 years old.
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New or progressive cancer (breast, lung, colorectal, prostate), histologically proven or strong clinical suspicion, fulfilling the tumor specific criteria.
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Estimated life expectancy greater than 6 months.
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At least one moderate/severe multimorbidity inclusion criteria other than current cancer (see separate list under 5.3).
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Patients must be willing and able to comply with study procedures.
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Voluntarily signed and dated written informed consents prior to any study specific procedure.
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QLQ-C30 Quality of Life Questionnaire fully completed at baseline, before inclusion.
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Patients affiliated with a French social security scheme in accordance with the French law on biomedical research (Article 1121-11 of the French Code of Public health).
Tumor specific inclusion criteria
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Specific inclusion criteria for breast cancer:
9.1. Non-metastatic breast cancer (M0):
- No prior treatment for the current breast cancer.
- All 3 criteria required:
o Clinical staging: cT2-3-4 Nany, or cTany N1-2-3;
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The cancer specialist considers* surgery;
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The cancer specialist considers* radiotherapy and/or chemotherapy. 9.2. Metastatic breast cancer (M1): Both criteria required:
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The cancer specialist considers* chemotherapy or PARP-inhibitors or mTOR-inhibitors / PIK3CA inhibitors; Previous endocrine therapy +/- CDK4/6 inhibitors is allowed;
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The patient received maximum 1 prior line of chemotherapy for metastatic disease.
- 'consider' implies that this treatment may be a treatment option for this patient in this particular setting. If at a later point, a different treatment choice is made, the patient remains eligible.
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-
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Specific inclusion criteria for colorectal cancer:
10.1. Non-metastatic colorectal cancer (M0):
- No prior therapy for the current tumor in the recruiting hospital
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At least one of the 3 criteria required:
o The cancer specialist considers* surgery;
- The cancer specialist considers* radiotherapy;
- The cancer specialist considers* chemotherapy and/or immunotherapy. 10.2. Metastatic colorectal cancer (M1):
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The cancer specialist considers* first or second line systemic therapy and/or radiotherapy (+/- surgery). No previous chemotherapy allowed except adjuvant/perioperative chemotherapy stopped for more than 12 months.
- 'consider' implies that this treatment may be a treatment option for this patient in this particular setting. If at a later point, a different treatment choice is made, the patient remains eligible.
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Specific inclusion criteria for lung cancer:
11.1. Non-metastatic lung cancer (M0):
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No prior therapy for the current tumor in the recruiting hospital
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At least one of the 3 criteria required:
- The cancer specialist considers* surgery (patients considered for treatment with percutaneous thermoablation alone are not eligible);
- The cancer specialist considers* radiotherapy (except SBRT);
- The cancer specialist considers* systemic therapy. Possible systemic therapies are chemotherapy and/or immune therapy and/or targeted therapy. Patients only considered* for monotherapy with anti-EGFR TKI or somatostatin analog are not eligible.
11.2. Metastatic lung cancer (M1):
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The cancer specialist considers* first or second line systemic therapy. Possible systemic therapies are chemotherapy and/or immune therapy and/or targeted therapy. Patients only considered* for monotherapy with anti-EGFR TKI or somatostatin analog are not eligible.
*'consider' implies that this treatment may be a treatment option for this patient in this particular setting. If at a later point, a different treatment choice is made, the patient remains eligible.
12. Specific inclusion criteria for prostate cancer: 12.1. Non-metastatic prostate cancer (M0): one of the following:
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First diagnosis M0 prostate cancer (no therapy received yet for prostate cancer): at least one of the 2 criteria required:
o The cancer specialist considers* radiotherapy;
o The cancer specialist considers* hormone therapy (ADT +/- combination Abiraterone and Prednisone).
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Salvage treatment M0 prostate cancer (received prior surgery at least 6 months before):
o The cancer specialist considers* radiotherapy (+/- ADT)
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Non-metastatic castration resistant prostate cancer:
- The cancer specialist considers* treatment intensification (ADT + Enzalutamide or Apalutamide or Darolutamide).
12.2. Metastatic prostate cancer (M1): - The cancer specialist considers* treatment with Abiraterone or Enzalutamide or Apalutamide, or Docetaxel or Cabazitaxel or PARP-inhibitors or Lutetium PSMA.
*'consider' implies that this treatment may be a treatment option for this patient in this particular setting. If at a later point, a different treatment choice is made, the patient remains eligible.
Exclusion Criteria:
- Mental illness/cognitive impairment that limits ability to provide consent or complete trial procedures.
- Participating to an interventional clinical trial with a non-registered anticancer drug or to another geriatric intervention trial.
- Patients and caregivers are unable or unwilling to use ICT-devices (tablet,computer, smartphone) or the Internet according to protocol.
- Patient already included in this study.
Key Trial Info
Start Date :
October 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
720 Patients enrolled
Trial Details
Trial ID
NCT05720910
Start Date
October 15 2024
End Date
April 1 2027
Last Update
January 15 2026
Active Locations (10)
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1
Centre Hospitalier de la Côte Basque
Bayonne, France, 64109
2
Institut Bergonié
Bordeaux, France, 33076
3
Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, France, 85000
4
Centre Léon Bérard
Lyon, France, 69373