ABCSG C08/EXERCISE Details

Start:
11/2018
Randomizing:
open

Contact ABCSG-Trial office

E-mail: info@abcsg.at
Phone: +43 1 408 92 30
Fax: +43 1 409 09 90

Design

Randomized phase-III-trial of endurance exercise following adjuvant chemotherapy in colorectal cancer.

ABCSG C08/EXERCISE Design
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Objectives:

Primary:

To evaluate the efficacy of endurance exercise following adjuvant chemotherapy for colorectal cancer in arm A compared to arm B only doing their usual physical activities with regard to DFS.

Secondary:

  • Efficacy objectives
    Evaluation of relapse free survival (RFS)
    Evaluation of overall survival (OS)
  • Physical activity objectives
    Evaluation of physical activities
    Evaluation of endurance exercise
    Evaluation of performance enhancement
    Relationship between physical activities, endurance exercise and performance enhancement and DFS, RFS and OS
  • Objectives related to patient reported outcomes
    Evaluation of patient reported outcomes with respect to fatigue
    Evaluation of patient reported outcomes with respect to emotional functioning/ well being
    Evaluation of patient reported outcomes with respect to physical functioning/ well being
    Evaluation of patient reported outcomes with respect to global quality of life
    Relationship between patient reported outcomes and MET-hours
  • Objectives related to cost-effectiveness / -utility (optional)
    Optional evaluation of cost-effectiveness/-utility
  • Objectives related to body composition
    Evaluation of body composition with regard to DFS, RFS and OS.
  • Objectives related to cardiovascular diseases
    Evaluation of the impact of physical activity on cardiac disease

Safety objectives

Evaluation of the incidence of physical activity related SAEs and physical activity related deaths

Evaluation of time from study start to physical activity related SAEs

Exploratory objective

Evaluation of molecular and biochemical markers

Inclusion criteria:

  1. Completely resected, histologically confirmed adenocarcinoma of the colon or rectum
    colon cancer: stage II with risk factors (T4, poorly differentiated adenocarinoma, vascular invasion, lymphatic vessel invasion, obstruction or tumor perforation at initial presentation, < 12 regional lymph nodes examined) and stage III as per (American Joint Committee on Cancer) Colon and Rectum Cancer Staging version 7 (please refer to Appendix 6).
    rectal cancer: stage II (T3 or T4, each being N0, M0) and stage III (every T, N1 or N2, each being M0) as per AJCC (American Joint Committee on Cancer) Colon and Rectum Cancer Staging version 7.
  2. Patients, who have completed adjuvant chemotherapy 4-16 weeks prior to randomization
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  4. Age ≥18 years
  5. Adequate hematologic functions £28d prior to randomization
    – platelet count > 50 x 109/L
    – hemoglobin > 8 g/dL
  6. Able to perform endurance exercise according to protocol
  7. Ability to perform ergometry in order to assess physical capability at the discretion of the investigator
  8. Signed informed consent prior to randomization

Exclusion criteria:

  1. Significant comorbid conditions precluding participation in a physical activity program (investigators decision)
  2. Disabled patients unable to participate in the physical activity program
  3. Regular (3-times a week) vigorous physical activity of >150 minutes (type of physical activity: bicycling, cross walking (crosstrainer), jogging, walking at a brisk pace, nordic walking, cross country skiing) within the last year before diagnosis of colorectal cancer
  4. Locoregional or distant metastatic disease within 6 weeks prior to randomization
  5. Patients unwilling to complete endurance exercise or complete all questionnaires related to the study
  6. Past or current history of other malignant neoplasms other than CRC in the last 5 years except basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
  7. Clinically significant cardiovascular disease (including myocardial infarction < 6 month before randomization, unstable angina, symptomatic congestive heart failure NYHA II-IV, serious uncontrolled cardiac arrhythmia, pre-excitation syndromes (eg Wolff-Parkinson-White-Syndrome), high grade or complete AV-Block, permanent pacemaker stimulation, uncontrolled hypertension (systolic blood pressure >150 mmHg), aortic valve stenosis, moderate to high-grade valve disease, endo-, myo-, pericarditis, acute aortic dissection, acute pulmonary embolism, acute phlebothrombosis of the lower extremity
  8. Left bundle branch block
  9. Current study with chemotherapy or radiation
  10. Current pregnancy or plans to become pregnant within the next 3 years