At a glance
ClinicalIndex Comparison Record- ✓Age 70 years or older
- ✓Colorectal cancer with distant metastases
- ✓No localized treatment options available
- ✓Candidate for first-line palliative chemotherapy
- ✕Prior palliative chemotherapy received
- ✕Scheduled local treatment of metastases
- ✕Candidate for triple chemotherapy
- ✕Prior adjuvant chemotherapy within one year
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
DOSAGE Study: a Multicenter Randomized Phase III Trial of DOSe-reduced Chemotherapy for Advanced Colorectal Cancer in Older Patients
In Brief
A Phase 3 clinical trial evaluating Doublet Chemotherapy, Standard Dose (100%), Doublet Chemotherapy, Dose-reduced (75%), and 2 other interventions for Older Patients and 3 related conditions. Currently recruiting, targeting 587 participants across 36 sites.
Detailed Summary
The goal of this phase III, open-label, non-inferiority randomized controlled clinical trial is compare upfront dose-reduced chemotherapy with the standard dose chemotherapy in older patients ( ≥70 years) with metastasized colorectal cancer, with regard to progression-free survival (PFS). The choice between monotherapy (a fluoropyrimidine) and doublet chemotherapy (a fluoropyrimidine with oxaliplatin) will be made for each individual patient based on expected risk of chemotherapy toxicity (according to the G8 screening). Patients classified as low risk of toxicity will be randomized between doublet chemotherapy in either full-dose, or with an upfront dose-reduction of 25%. Patients classified as high risk will be randomized between monotherapy in either full-dose or upfront dose-reduction. Primary outcome is PFS. Secondary endpoints include grade ≥3 toxicity, QoL, physical functioning, overall survival, number of treatment cycles, dose reductions, hospital admissions, cumulative received dosage and cost-effectiveness.
Study Details
Timeline
Interventions
Capecitabine 1000mg / m2 oral at day 1-14 (every 3 weeks) Oxaliplatin 130mg/m2 at day 1 (every 3 weeks) OR 5-FU 400mg/m2 IV bolus at day 1 followed by 2400mg/m2 in 46 hours (every 2 weeks) Leucovorin 400mg/m2 day 1 (every 2 weeks) Oxaliplatin 85mg/m2 day 1 (every 2 weeks)
75% of: Capecitabine 1000mg / m2 oral at day 1-14 (every 3 weeks) Oxaliplatin 130mg/m2 at day 1 (every 3 weeks) OR 5-FU 400mg/m2 IV bolus at day 1 followed by 2400mg/m2 in 46 hours (every 2 weeks) Leucovorin 400mg/m2 day 1 (every 2 weeks) Oxaliplatin 85mg/m2 day 1 (every 2 weeks)
\- Capecitabine 1000mg/m2 oral at day 1-14 (every 3 weeks)
75% of: \- Capecitabine 1000mg/m2 oral at day 1-14 (every 3 weeks)