CHALLENGE
Colon Health and Life-Long Exercise Change (CHALLENGE, CCTG CO.21): structured exercise after adjuvant chemotherapy for colon cancer
Phase 3N = 889NCT00819208
- Population
- 889 patients with resected colon cancer who had completed adjuvant chemotherapy (445 exercise, 444 health education); median follow-up 7.9 years. The design paper describes eligible survivors as having high-risk stage II or stage III colon cancer and having completed adjuvant therapy within the previous 2-6 months.
- Design
- Randomised phase 3 trial at 55 centres comparing a 3-year structured exercise programme with health-education materials alone, started after completion of adjuvant chemotherapy for resected colon cancer; enrolment 2009 through 2024. Primary endpoint disease-free survival (events: disease recurrence, new primary cancer or death). The 2008 design paper describes the planned exercise intervention as a behavioural support programme with supervised sessions over 3 years, tapering to less frequent sessions, and planned 962 participants.
- Primary endpoint
- DFS
- Arms
- Health-education materials (control, n = 444): Health-education materials alone over 3 years
- Structured exercise programme (experimental, n = 445): Structured exercise programme over 3 years
- People
- Courneya KS, Canadian Cancer Trials Group
DFSHR 0.72 (95% CI 0.55–0.94)Δ 60-month DFS+6.4 pointsOSHR 0.63 (95% CI 0.43–0.94)Δ 96-month OS+7.1 pointsΔ Musculoskeletal adverse events+7 points
Show the numbers
| Endpoint | Analysis | Structured exercise programme | Health-education materials | Effect |
|---|---|---|---|---|
| DFSRandomised patients with resected colon cancer who completed adjuvant chemotherapy (889); the abstract does not label the analysis population | primarymedian follow-up 7.9 yearsCourneya 2025 | 80.3% at 5 y | 73.9% at 5 y | HR 0.72 (95% CI 0.55–0.94)P=0.02Difference in 5-year DFS 6.4 percentage points (95% CI 0.6 to 12.2). DFS counted disease recurrence, a new primary cancer or death. |
| OSRandomised patients with resected colon cancer who completed adjuvant chemotherapy (889); the abstract does not label the analysis population | primarymedian follow-up 7.9 yearsCourneya 2025 | 90.3% at 8 y | 83.2% at 8 y | HR 0.63 (95% CI 0.43–0.94)Overall survival was not the primary endpoint; the abstract says the results 'support' longer overall survival and gives no P value for the hazard ratio. Difference in 8-year OS 7.1 percentage points (95% CI 1.8 to 12.3). |
| Musculoskeletal adverse eventsRandomised patients with resected colon cancer who completed adjuvant chemotherapy (889); the abstract does not label the analysis population | primaryCourneya 2025 | 18.5% | 11.5% | — |
| Endpoint | Analysis | Structured exercise programme | Health-education materials | Effect |
|---|---|---|---|---|
| DFSRandomised patients with resected colon cancer who completed adjuvant chemotherapy (889); the abstract does not label the analysis population | primarymedian follow-up 7.9 yearsCourneya 2025 | 80.3% at 5 y | 73.9% at 5 y | HR 0.72 (95% CI 0.55–0.94)P=0.02Difference in 5-year DFS 6.4 percentage points (95% CI 0.6 to 12.2). DFS counted disease recurrence, a new primary cancer or death. |
| OSRandomised patients with resected colon cancer who completed adjuvant chemotherapy (889); the abstract does not label the analysis population | primarymedian follow-up 7.9 yearsCourneya 2025 | 90.3% at 8 y | 83.2% at 8 y | HR 0.63 (95% CI 0.43–0.94)Overall survival was not the primary endpoint; the abstract says the results 'support' longer overall survival and gives no P value for the hazard ratio. Difference in 8-year OS 7.1 percentage points (95% CI 1.8 to 12.3). |
| Musculoskeletal adverse eventsRandomised patients with resected colon cancer who completed adjuvant chemotherapy (889); the abstract does not label the analysis population | primaryCourneya 2025 | 18.5% | 11.5% | — |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| DFS | 0.72 | 0.55–0.94 |
| OS | 0.63 | 0.43–0.94 |