Physical activity program in patients with metastatic colorectal cancer who receive palliative first-line chemotherapy: A randomized controlled phase III trial—(ACTIVE-2 SAKK 41/14).
Bibliographic record
Abstract
TPS3621 Background: Exercise has become a main focus of basic and clinical research worldwide during the current pandemic of physical inactivity. A clear link between inactivity and cancer incidence/relapse has been established, particularly for colon cancer, the third most common cancer. However, whether exercise has an impact on disease course and survival in advanced disease is unknown. Exercise modifies key host factors that are determinants of chemotherapy efficacy such as metabolic and immunologic tumor microenvironment, drug tolerability and treatment adherence. Thus, we aim to assess whether a supervised exercise program concomitant to first-line palliative chemotherapy for patients with metastatic colorectal cancer (mCRC) enhances chemotherapy efficacy and, therefore, increases survival and decreases symptom burden as compared to patients treated with chemotherapy alone. Methods: Patients with newly diagnosed mCRC are stratified (pre-diagnosis physical fitness, RAS-mutational status, primary tumor location, alkaline phosphatase levels) and randomly assigned to undergo standard systemic treatment and care-as-usual or standard systemic treatment combined with a 12-week structured physical activity (PA) program with twice weekly supervised, heart-rate guided interval training on a bike ergometer. Both groups undergo regular imaging with CT/MRI in order to assess the 1°endpoint of progression-free survival (PFS), i.e. the time between diagnosis and disease progression or death. Radiologists who are blinded to the group assignment will review imaging. A total of 439 events occurring in 524 patients will be needed to show a clinically meaningful HR of 0.75 for PFS with 80% power and an α of 0.03. Co-primary endpoint is self-reported symptom burden as measured by the revised Edmonton Symptom Assessment Scale (rESAS). 50 patients from 17 Swiss and Austrian Centers have been randomized. A planned feasibility analysis of the first 40 patients is ongoing. Clinical trial information: NCT02597075.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.007 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".