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DOSAGE Study: Upfront Dose-Reduced Chemotherapy in Older Patients with Metastatic Colorectal Cancer
Sponsor: Leiden University Medical Center
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.
Official title: DOSAGE Study: a Multicenter Randomized Phase III Trial of DOSe-reduced Chemotherapy for Advanced Colorectal Cancer in Older Patients
Key Details
Gender
All
Age Range
70 Years - Any
Study Type
INTERVENTIONAL
Enrollment
587
Start Date
2024-07-01
Completion Date
2028-12
Last Updated
2024-10-16
Healthy Volunteers
No
Interventions
Doublet Chemotherapy, Standard Dose (100%)
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)
Doublet Chemotherapy, Dose-reduced (75%)
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)
Monotherapy, Standard Dose (100%)
\- Capecitabine 1000mg/m2 oral at day 1-14 (every 3 weeks)
Monotherapy, Dose-reduced (75%)
75% of: \- Capecitabine 1000mg/m2 oral at day 1-14 (every 3 weeks)
Locations (36)
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
Ziekenhuis Amstelland
Amstelveen, Netherlands
Amsterdam UMC
Amsterdam, Netherlands
Rijnstate
Arnhem, Netherlands
Wilhelmina Ziekenhuis
Assen, Netherlands
Rode Kruis Ziekenhuis
Beverwijk, Netherlands
Slingeland Ziekenhuis
Doetinchem, Netherlands
Ziekenhuis Gelderse Vallei
Ede, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Treant
Emmen, Netherlands
Admiraal de Ruyter Ziekenhuis
Goes, Netherlands
Beatrixziekenhuis
Gorinchem, Netherlands
Groene Hart Ziekenhuis
Gouda, Netherlands
Saxenburgh
Hardenberg, Netherlands
St. Jansdal Ziekenhuis
Harderwijk, Netherlands
Elkerliek Ziekenhuis
Helmond, Netherlands
Tergooi MC
Hilversum, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Alrijne Ziekenhuis
Leiderdorp, Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands
Laurentius Ziekenhuis
Roermond, Netherlands
Bravis ziekenhuis
Roosendaal, Netherlands
Ikazia Ziekenhuis
Rotterdam, Netherlands
Maasstad Ziekenhuis
Rotterdam, Netherlands
Ommelander Ziekenhuis
Scheemda, Netherlands
ZorgSaam Zorggroep Zeeuws-Vlaanderen
Terneuzen, Netherlands
Haaglanden Medisch Centrum
The Hague, Netherlands
Hagaziekenhuis
The Hague, Netherlands
Bernhoven
Uden, Netherlands
Diakonessenhuis
Utrecht, Netherlands
St Antonius
Utrecht, Netherlands
VieCuri Medisch Centrum
Venlo, Netherlands
Streekziekenhuis Koninging Beatrix
Winterswijk, Netherlands
Zaans Medisch Centrum
Zaandam, Netherlands