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PHYSICAL ACTIVITY PROGRAM IN PATIENTS WITH METASTATIC COLORECTAL
CANCER WHO RECEIVE PALLIATIVE FIRST-LINE CHEMOTHERAPY. A MULTICENTER
OPEN LABEL RANDOMIZED CONTROLLED PHASE III TRIAL
“Etude : SAKK 41/14 - CRC et sport”
Sponsor : SAKK
CONTACTS AUX HUG : Unité de recherche en Onco-Hématologie, Fondation DFDL
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Coordinatrice de l’étude : Mme Cristina Riccadonna, 079 553 24 29
Investigateur responsable: Dr Thibaud Koessler, 079 553 24 09
Secrétariat: Mme Florence Marti-Klay, 022 372 29 01
DESIGN DE L’ETUDE
524 patients seront inclus dans cette étude et randomisés (1:1), selon le schéma
suivant :
Diagnostic de cancer colorectal
métastatique
Randomisation 1:1
Chimiothérapie standard
+
Programme
d’activité
physique structuré
et
podomètre
Chimiothérapie standard
Follow-up
Etude SAKK 41/14-Sport, v1.0
vian 22.07.16
OBJECTIF DE L'ETUDE
L’objectif de cette étude est d’étudier si un programme d’activité physique structuré
pendant une chimiothérapie palliative améliore la survie sans progression et/ou la
qualité de vie des patients chez les patients atteints d’un cancer colorectal
métastatique.
CRITERES D’ELIGIBILITE
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INCLUSION CRITERIA
1
5
6
7
Written informed consent according to ICH/GCP regulations before randomization.
Patient with histologically or cytologically confirmed colorectal carcinoma (CRC) required
to start palliative first-line systemic therapy for inoperable or metastatic disease.
Patients who were diagnosed with histologically or cytologically confirmed non-metastatic
CRC earlier and now relapsed with metastatic disease are also eligible, if any prior neoadjuvant
or adjuvant chemotherapy has been completed more than 4 months before
inclusion into this trial.
Patient has measurable disease on CT scan or MRI to be performed within 4 weeks
before randomization (measurability criteria according to RECIST 1.1 [1], non-nodal
lesions ≥10mm, lymph nodes ≥15mm OR evaluable disease i.e. patient with nonmeasurable
metastases but elevated serum tumor-marker (CEA at least >2xULN).
Command of written and spoken language allowing for informed consent and for filling in
trial questionnaires.
Baseline patient-reported outcomes (PROs) have been completed.
WHO performance status 0-2 (see Appendix 3).
Age 18-75 (80) years (if WHO is 0-1 upper age limit is 80 years).
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EXCLUSION CRITERIA
2
3
4
1
2
3
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5
6
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10
Cycle ergometer stress test (completed within 28 days before trial start) shows significant
signs of ischemic heart disease or high-grade arrhythmias, which preclude an exercise
program.
Pre-existing severe medical conditions precluding participation in a physical activity
program as determined by the local investigator. Such conditions include: chronic heart
failure (greater than NYHA II see Appendices AAppendix 5), recent myocardial infarction
(less than 3 months ago), unstable angina pectoris, clinically significant arrhythmias,
uncontrolled hypertension with repeated systolic blood pressure above 160mmHg, and
COPD (requiring oxygen supply or GOLD stadium greater than 2).
Inability to ride a cycle ergometer e.g. for musculoskeletal reasons
Inability to perform 50 Watt on a cycle ergometer (during Cycle ergometer stress test), for
any reason.
Patients who are a priori planned for curative surgery including metastasectomy.
It is allowed to include patients for whom metastasectomy might be an option if
chemotherapy induces a significant response.
Any serious underlying medical condition (at the judgment of the investigator) which could
impair the ability of the patient to participate in the trial (e.g. active autoimmune disease,
uncontrolled diabetes).
Concurrent treatment in a trial with experimental drugs or other anti-cancer therapy, which
are hypothesized to alter tumor progression. Participation in an observational trial or a
translational trial is allowed.
Previous malignancy within 5 years with the exception of adequately treated cervical
carcinoma in situ, localized non-melanoma skin cancer, superficial bladder cancer (nonmuscle
invasive disease), localized prostate cancer (T1-3).
Psychiatric disorder precluding understanding of trial information, giving informed consent,
filling out PRO forms, or interfering with compliance.
Any psychological, familial, sociological or geographical condition potentially hampering
proper compliance with the trial protocol.
Etude SAKK 41/14-Sport, v1.0
vian 22.07.16