Actively Recruiting
DOSAGE Study: Upfront Dose-Reduced Chemotherapy in Older Patients with Metastatic Colorectal Cancer
Led by Leiden University Medical Center · Updated on 2024-10-16
587
Participants Needed
36
Research Sites
230 weeks
Total Duration
On this page
Sponsors
L
Leiden University Medical Center
Lead Sponsor
D
Dutch Colorectal Cancer Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
DOSAGE Study: Upfront Dose-Reduced Chemotherapy in Older Patients with Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 70 years or older with colorectal cancer and distant metastases without localized treatment options.
- 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.
You will not qualify if you...
- Patients who received prior palliative chemotherapy
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 36 locations
1
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
Not Yet Recruiting
2
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
Not Yet Recruiting
3
Ziekenhuis Amstelland
Amstelveen, Netherlands
Not Yet Recruiting
4
Amsterdam UMC
Amsterdam, Netherlands
Not Yet Recruiting
5
Rijnstate
Arnhem, Netherlands
Not Yet Recruiting
6
Wilhelmina Ziekenhuis
Assen, Netherlands
Not Yet Recruiting
7
Rode Kruis Ziekenhuis
Beverwijk, Netherlands
Not Yet Recruiting
8
Slingeland Ziekenhuis
Doetinchem, Netherlands
Not Yet Recruiting
9
Ziekenhuis Gelderse Vallei
Ede, Netherlands
Not Yet Recruiting
10
Catharina Ziekenhuis
Eindhoven, Netherlands
Actively Recruiting
11
Treant
Emmen, Netherlands
Not Yet Recruiting
12
Admiraal de Ruyter Ziekenhuis
Goes, Netherlands
Not Yet Recruiting
13
Beatrixziekenhuis
Gorinchem, Netherlands
Not Yet Recruiting
14
Groene Hart Ziekenhuis
Gouda, Netherlands
Actively Recruiting
15
Saxenburgh
Hardenberg, Netherlands
Not Yet Recruiting
16
St. Jansdal Ziekenhuis
Harderwijk, Netherlands
Not Yet Recruiting
17
Elkerliek Ziekenhuis
Helmond, Netherlands
Actively Recruiting
18
Tergooi MC
Hilversum, Netherlands
Actively Recruiting
19
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
Not Yet Recruiting
20
Leiden University Medical Center
Leiden, Netherlands
Actively Recruiting
21
Alrijne Ziekenhuis
Leiderdorp, Netherlands
Not Yet Recruiting
22
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands
Not Yet Recruiting
23
Laurentius Ziekenhuis
Roermond, Netherlands
Not Yet Recruiting
24
Bravis ziekenhuis
Roosendaal, Netherlands
Actively Recruiting
25
Ikazia Ziekenhuis
Rotterdam, Netherlands
Actively Recruiting
26
Maasstad Ziekenhuis
Rotterdam, Netherlands
Not Yet Recruiting
27
Ommelander Ziekenhuis
Scheemda, Netherlands
Not Yet Recruiting
28
ZorgSaam Zorggroep Zeeuws-Vlaanderen
Terneuzen, Netherlands
Actively Recruiting
29
Haaglanden Medisch Centrum
The Hague, Netherlands
Not Yet Recruiting
30
Hagaziekenhuis
The Hague, Netherlands
Actively Recruiting
31
Bernhoven
Uden, Netherlands
Not Yet Recruiting
32
Diakonessenhuis
Utrecht, Netherlands
Not Yet Recruiting
33
St Antonius
Utrecht, Netherlands
Not Yet Recruiting
34
VieCuri Medisch Centrum
Venlo, Netherlands
Not Yet Recruiting
35
Streekziekenhuis Koninging Beatrix
Winterswijk, Netherlands
Actively Recruiting
36
Zaans Medisch Centrum
Zaandam, Netherlands
Not Yet Recruiting
Research Team
J
Joosje Baltussen
CONTACT
D
Data Management: Clinical Research Center LUMC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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