RecruitingPhase 3NCT06275958

DOSAGE Study: Upfront Dose-Reduced Chemotherapy in Older Patients with Metastatic Colorectal Cancer

DOSAGE Study: a Multicenter Randomized Phase III Trial of DOSe-reduced Chemotherapy for Advanced Colorectal Cancer in Older Patients

Sponsor

Leiden University Medical Center

Enrollment

587 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer Metastatic Cancer Older Patients Candidates for Palliative Chemotherapy

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.

Eligibility

Min Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study, called DOSAGE, is testing whether starting with a lower dose of chemotherapy (then adjusting up if tolerated) is safer and equally effective compared to starting with a full standard dose in older adults with metastatic colorectal cancer. **You may be eligible if...** - You are 70 years or older - You have colorectal cancer that has spread to other parts of the body (metastatic) - You have not yet received chemotherapy for your metastatic disease - Your doctor believes you are a good candidate for palliative (non-curative) chemotherapy - You can understand Dutch - Your blood counts and organ function are adequate **You may NOT be eligible if...** - You have already received palliative chemotherapy - You are scheduled for local treatment of metastases (e.g., liver surgery) - You have a complete or partial deficiency of the DPD enzyme (affects chemo metabolism) - Your colorectal cancer has a specific genetic marker called MSI-high - You have HIV, active hepatitis, severe kidney failure, or severe cognitive impairment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDoublet 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)

DRUGDoublet 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)

DRUGMonotherapy, Standard Dose (100%)

\- Capecitabine 1000mg/m2 oral at day 1-14 (every 3 weeks)

DRUGMonotherapy, 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

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NCT06275958

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