Phase
Condition
Lung Cancer
Prostate Cancer
Colorectal Cancer
Treatment
GERONTE
Clinical Study ID
Ages 70-130 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- General inclusion criteria
Age ≥ 70 years old.
New or progressive cancer (breast, lung, colorectal, prostate), histologicallyproven or strong clinical suspicion, fulfilling the tumor specific criteria.
Estimated life expectancy greater than 6 months.
At least one moderate/severe multimorbidity inclusion criteria other than currentcancer (see separate list under 5.3).
Patients must be willing and able to comply with study procedures.
Voluntarily signed and dated written informed consents prior to any study specificprocedure.
QLQ-C30 Quality of Life Questionnaire fully completed at baseline, before inclusion.
Patients affiliated with a French social security scheme in accordance with theFrench law on biomedical research (Article 1121-11 of the French Code of Publichealth). Tumor specific inclusion criteria
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;
The cancer specialist considers* surgery;
The cancer specialist considers* radiotherapy and/or chemotherapy. 9.2.Metastatic breast cancer (M1): Both criteria required:
The cancer specialist considers* chemotherapy or PARP-inhibitors ormTOR-inhibitors / PIK3CA inhibitors; Previous endocrine therapy +/- CDK4/6inhibitors is allowed;
The patient received maximum 1 prior line of chemotherapy for metastaticdisease.
'consider' implies that this treatment may be a treatment option forthis patient in this particular setting. If at a later point, adifferent treatment choice is made, the patient remains eligible.
- Specific inclusion criteria for colorectal cancer:
10.1. Non-metastatic colorectal cancer (M0):
No prior therapy for the current tumor in the recruiting hospital
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):
The cancer specialist considers* first or second line systemic therapy and/orradiotherapy (+/- surgery). No previous chemotherapy allowed exceptadjuvant/perioperative chemotherapy stopped for more than 12 months.
'consider' implies that this treatment may be a treatment option for thispatient in this particular setting. If at a later point, a differenttreatment choice is made, the patient remains eligible.
- Specific inclusion criteria for lung cancer:
11.1. Non-metastatic lung cancer (M0):
No prior therapy for the current tumor in the recruiting hospital
At least one of the 3 criteria required:
The cancer specialist considers* surgery (patients considered for treatmentwith percutaneous thermoablation alone are not eligible);
The cancer specialist considers* radiotherapy (except SBRT);
The cancer specialist considers* systemic therapy. Possible systemic therapiesare chemotherapy and/or immune therapy and/or targeted therapy. Patients onlyconsidered* for monotherapy with anti-EGFR TKI or somatostatin analog are noteligible.
11.2. Metastatic lung cancer (M1):
- The cancer specialist considers* first or second line systemic therapy. Possiblesystemic therapies are chemotherapy and/or immune therapy and/or targeted therapy.Patients only considered* for monotherapy with anti-EGFR TKI or somatostatin analogare not eligible.
*'consider' implies that this treatment may be a treatment option for this patientin this particular setting. If at a later point, a different treatment choice ismade, the patient remains eligible.
- Specific inclusion criteria for prostate cancer: 12.1. Non-metastatic prostatecancer (M0): one of the following:
First diagnosis M0 prostate cancer (no therapy received yet for prostate cancer): atleast one of the 2 criteria required: o The cancer specialist considers* radiotherapy; o The cancer specialist considers* hormone therapy (ADT +/- combination Abirateroneand Prednisone).
Salvage treatment M0 prostate cancer (received prior surgery at least 6 monthsbefore): o The cancer specialist considers* radiotherapy (+/- ADT)
Non-metastatic castration resistant prostate cancer:
The cancer specialist considers* treatment intensification (ADT + Enzalutamideor 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
Exclusion Criteria:
Mental illness/cognitive impairment that limits ability to provide consent orcomplete trial procedures.
Participating to an interventional clinical trial with a non-registered anticancerdrug 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.
Study Design
Study Description
Connect with a study center
Centre Hospitalier de la Côte Basque
Bayonne, 64109
FranceActive - Recruiting
Institut Bergonié
Bordeaux, 33076
FranceActive - Recruiting
Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, 85000
FranceActive - Recruiting
Centre Azuréen de Cancérologie
Mougins, 06250
FranceActive - Recruiting
Centre Antoine Lacassagne
Nice, 06189
FranceActive - Recruiting
Centre Hospitalier Universitaire de Nice
Nice, 06000
FranceActive - Recruiting
Hôpital Tenon AP-HP
Paris, 75020
FranceActive - Recruiting
Groupe Hospitalier Rance Emeraude
Saint-Malo, 35400
FranceActive - Recruiting
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