DOSAGE Study: Upfront Dose-Reduced Chemotherapy in Older Patients with Metastatic Colorectal Cancer
NCT ID: NCT06275958
Last Updated: 2024-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
587 participants
INTERVENTIONAL
2024-07-01
2028-12-31
Brief Summary
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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.
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Detailed Description
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The DOSAGE study is a phase III, open-label, non-inferiority, randomized controlled clinical trial in patients aged ≥70 years with metastasized colorectal cancer eligible for palliative chemotherapy. All participating patients will undergo geriatric screening by the G8 questionnaire and will be classified as "low risk of toxicity" (G8-score of 15 or higher) or "high risk of toxicity" (G8-score of 14 or lower or judged as "high toxicity risk" by their treating oncologist). Patients classified as low risk will be randomized between a fluoropyrimidine and oxaliplatin in either full-dose, or with an upfront dose-reduction of 25%. Patients classified as high risk will be randomized between fluoropyrimidine monotherapy in either full-dose or upfront dose-reduction. Addition of targeted treatment (bevacizumab or epidermal growth factor receptor (EGFR) inhibition) is allowed. Patients with a moderate renal impairment (GFR 30- 50 mL/min) will be treated with 25% reduced starting dose of capecitabine when randomized for full dose treatment and treated with 40% reduced starting dose when randomized for 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. Given a non-inferiority margin of 8 weeks, 587 patients will be included (293/292 patients per arm).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Doublet therapy, full dose (low toxicity risk based on G8)
Low risk of toxicity: G8-score of 15 or higher
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 therapy, dose-reduced (low toxicity risk based on G8)
Low risk of toxicity: G8-score of 15 or higher
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)
Fluoropyrimidine monotherapy, full dose (high toxicity risk based on G8)
High risk of toxicity: G8-score of 14 or lower or judged as "high toxicity risk" by their treating oncologist
Monotherapy, Standard Dose (100%)
\- Capecitabine 1000mg/m2 oral at day 1-14 (every 3 weeks)
Fluoropyrimidine monotherapy, dose-reduced (high toxicity risk based on G8)
High risk of toxicity: G8-score of 14 or lower or judged as "high toxicity risk" by their treating oncologist
Monotherapy, Dose-reduced (75%)
75% of:
\- Capecitabine 1000mg/m2 oral at day 1-14 (every 3 weeks)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* Patients who are candidates for first-line palliative chemotherapy as judged by their treating oncologist
* Being able to understand the Dutch language
* Adequate bone marrow and organ function: Absolute neutrophil count (ANC) \> 1.5 x 10\^9 mmol/L, Hemoglobin (Hb) \> 6.0 mmol/L, Platelets \>100 x 109 / L, Serum bilirubin ≤ 2 x upper limit of normal (ULN), serum transaminases ≤ 3 x ULN without presence of liver metastases or ≤ 5x ULN with presence of liver metastases.
Exclusion Criteria
* Patients in whom local treatment of metastases is scheduled (i.e. liver surgery or stereotactic radiotherapy)
* Candidates for triple chemotherapy
* Patients who received prior adjuvant chemotherapy in the one year before inclusion in the study (chemotherapy before that time is allowed)
* Patients with complete or incomplete dihydropyrimidine dehydrogenase (DPD) deficiency
* Patients with Microsatellite instable (MSI)-high colorectal cancer
* Patients with HIV or active hepatitis
* Patients with severe kidney failure (defined as GFR ≤30ml/min)
* Patients with severe cognitive deficits making informed consent not possible
70 Years
ALL
No
Sponsors
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Dutch Colorectal Cancer Group
OTHER
Leiden University Medical Center
OTHER
Responsible Party
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Johanna E A Portielje, MD PhD
Professor Medical Oncology
Principal Investigators
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Johanneke Portielje, Professor
Role: PRINCIPAL_INVESTIGATOR
Leiden University Medical Center
Joosje Baltussen, MD
Role: STUDY_DIRECTOR
Leiden University Medical Center
Locations
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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
Countries
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Central Contacts
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References
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Baltussen JC, van den Bos F, Slingerland M, Binda TRR, Liefers GJ, van den Hout WB, Fiocco M, Verschoor AJ, Cloos-van Balen M, Holterhues C, Houtsma D, Jochems A, Spierings LEAMM, van Bodegom-Vos L, Mooijaart SP, Gelderblom H, Speetjens FM, de Glas NA, Portielje JEA. DOSAGE study: protocol for a phase III non-inferiority randomised trial investigating dose-reduced chemotherapy for advanced colorectal cancer in older patients. BMJ Open. 2024 Aug 13;14(8):e089882. doi: 10.1136/bmjopen-2024-089882.
Related Links
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DCCG Website
Other Identifiers
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2023-506115-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-506115-17
Identifier Type: -
Identifier Source: org_study_id
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