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SAKK 41/14 Active-2

SAKK 41/14 Active-2

Physical activity program in patients with metastatic colorectal cancer who receive palliative first-line chemotherapy. A multicenter open label randomized controlled trial.

Synopsis

Short title: SAKK 41/14 Active-2

Title: Physical activity program in patients with metastatic colorectal cancer who receive palliative first-line chemotherapy. A multicenter open label randomized controlled trial.

Status: open

Start: June 2016 (in Austria)

Coordinating Investigator: Univ. Prof. Dr. Josef Thaler (in Austria)

EudraCT Number: 2015-003733-10

ClinicalTrialsID: na

Number of patients: 300 (international)

Sponsor: SAKK (Swiss Group for Clinical Cancer Research), AGMT Sponsor representative in Austria

Design

All patients will undergo standard systemic therapy for metastatic colorectal cancer. Patients in the care-as-usual group are not actively encouraged to change their physical activity level e.g. to start a fitness program during chemotherapy.

The physical exercise ACTIVE-program describes a 12-week exercise program consisting of a combination of a bi-weekly aerobic exercise (cycle ergometer) supervised by a physical therapist and a self-paced increase in physical activity during daily life using a pedometer with a daily step goal as a motivational tool. The program will be individually tailored to each patient based on the training protocol and is aimed at increasing physical activity levels and cardiorespiratory fitness.

Primary objective:

To assess whether a structured physical activity program (PA) during palliative chemotherapy improves progression-free survival (PFS) and/or patient-reported outcomes (ESAS-r) in patients with metastatic colorectal cancer.

Primary endpoints:

The co-primary endpoints are PFS and patient-reported symptoms as measured by the ESAS-r (Edmonton Symptom Assessment System revised).

Secondary endpoints:
  • Efficacy
  • Chemotherapy-related endpoints and toxicities
  • Patient reported outcomes
  • Exercise endpoints

Inclusion/Exclusion criteria

Inclusion criteria (selected):
  • Written informed consent according to ICH/GCP regulations before randomization
  • Patients with histologically or cytologically confirmed colorectal carcinoma (CRC) who start palliative first-line systemic therapy for inoperable or metastatic disease.
    Note: Patients can be included before the start or within the first three weeks of first-line systemic treatment
  • Patients with histologically or cytologically confirmed colorectal carcinoma (CRC), who start first-line “conversion”-therapy for borderline resectable metastatic disease and will be reassessed for metastasectomy after 3-4 months of systemic treatment.
    Note: Patients can be included before the start or within the first three weeks of first-line systemic treatment
  • Patients who are diagnosed with metastatic disease and were initially treated with surgery and/or radiochemotherapy to the primary tumor are eligible (except if all disease sites/metastases have been removed)
  • Patients who have been curatively treated with histologically or cytologically confirmed nonmetastatic CRC previously and now relapse with metastatic disease are also eligible, irrespective of previous radiochemotherapy and/or adjuvant chemotherapy
  • Patients must have measurable disease on CT scan or MRI to be performed within 6 weeks before randomization (measurability criteria according to RECIST 1.1, non-nodal lesions ≥10 mm, 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
  • Age ≥18 years
Exclusion criteria (selected):
  • Pre-existing severe medical conditions precluding participation in a physical activity program as determined by the local investigator
  • Inability to ride a cycle ergometer e.g. for musculoskeletal reasons
  • Patients in whom all CRC metastases have been removed surgically

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