ABCSG C08-Exercise II: Trial of Endurance Exercise Following Adjuvant Chemotherapy for Colorectal… (NCT03822572) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
ABCSG C08-Exercise II: Trial of Endurance Exercise Following Adjuvant Chemotherapy for Colorectal Cancer
Austria92 participantsStarted 2019-02-14
Plain-language summary
ABCSG C08 is a randomized, two-arm, multicenter trial to investigate the efficacy of endurance exercise following adjuvant chemotherapy in patients with colorectal cancer.
Indication: Locally advanced colorectal cancer after adjuvant chemotherapy. Evidence supporting the beneficial effects of exercise programs during chemotherapy are available, the results across studies are not entirely consistent. Additional studies are needed to determine the optimal content, intensity, and form of training programs.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* completely resected, histologically confirmed adenocarcinoma of the colon or rectum
* patients, who have completed adjuvant chemotherapy 4-16 weeks prior to randomization
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Age ≥18 years
* adequate hematologic functions \<=28d prior to randomization
* able to perform endurance exercise according to protocol
* ability to perform ergometry in order to assess physical capability at the discretion of the investigator
* signed informed consent prior to randomization
Exclusion Criteria:
* significant comorbid conditions precluding participation in a physical activity program (investigators decision)
* disabled patients unable to participate in the physical activity program
* Regular (3-times a week) vigorous physical activity of \>150 minutes (type of physical activity: bicycling, cross walking (cross trainer), jogging, walking at a brisk pace, nordic walking, cross country skiing) within the last year before diagnosis of colorectal cancer
* patients unwilling to complete endurance exercise or complete all questionnaires related to the study
* past or current history of other malignant neoplasms other than colorectal cancer in the last 5 years except basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
* clinically significant cardiovascular disease
* left bundle branch block
* current study with chemotherapy or radiation
* current pregnancy or plans to become pregna…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary Endpoint - disease free survival (DFS)
Timeframe: 8 years (after Last Patient Out (LPO))
Trial details
NCT IDNCT03822572
SponsorAustrian Breast & Colorectal Cancer Study Group