Actively Recruiting
Led by Leiden University Medical Center · Updated on 2024-10-16
587
Participants Needed
36
Research Sites
26 weeks
Total Duration
L
Leiden University Medical Center
Lead Sponsor
D
Dutch Colorectal Cancer Group
Collaborating Sponsor
Researchers are evaluating chemotherapy dosing strategies in older patients aged 70 years and above who have metastatic colorectal cancer and are eligible for first-line palliative chemotherapy. This phase III randomized controlled trial aims to compare upfront dose-reduced chemotherapy with standard full-dose chemotherapy, focusing on progression-free survival (PFS). Patients are assessed using the Geriatric 8 (G8) questionnaire to determine their risk of chemotherapy toxicity, which guides treatment assignment. The study seeks to balance treatment effectiveness with minimizing toxicity, hospital admissions, and maintaining quality of life (QoL) and physical functioning. Participants classified as low risk for toxicity (G8 score 15 or higher) are randomized to receive either doublet chemotherapy (a fluoropyrimidine combined with oxaliplatin) at full dose or with a 25% dose reduction upfront. Those at high risk (G8 score 14 or lower or judged high risk by their oncologist) receive fluoropyrimidine monotherapy either at full dose or with a 25% dose reduction. The study also allows the addition of targeted treatments like bevacizumab or EGFR inhibitors. Dose adjustments are made for patients with moderate kidney impairment. Chemotherapy is given orally or intravenously on schedules varying between every two and three weeks, depending on the regimen. Participants will be closely monitored throughout treatment, with assessments including radiological or clinical evaluations for disease progression, quality of life and physical functioning questionnaires at 1, 3, 6, and 12 months, and tracking of chemotherapy toxicity, overall survival, treatment cycles, dose changes, hospital admissions, and cumulative drug dosage. Safety and cost-effectiveness will also be evaluated over an average study duration of eight months and up to one year for some outcomes. The study plans to include 587 patients and will continue until December 2028.
CONDITIONS
DOSAGE Study: Upfront Dose-Reduced Chemotherapy in Older Patients with Metastatic Colorectal Cancer
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 8 months
Participants receive dose-reduced or full-dose chemotherapy based on their risk of treatment toxicity assessed by the G8 questionnaire. Treatment includes either fluoropyrimidine monotherapy or doublet chemotherapy with or without targeted therapies.
Regular visits every 2 to 3 weeks during chemotherapy cycles
Duration - Up to 1 year after treatment initiation
Participants are monitored for progression-free survival, quality of life, physical functioning, toxicity, hospital admissions, and overall survival up to at least one year after randomization.
Visits at 1, 3, 6, and 12 months after randomization
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
J
Joosje Baltussen
D
Data Management: Clinical Research Center LUMC
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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Joosje C Baltussen, Frederiek van den Bos, Marije Slingerland...
https://pubmed.ncbi.nlm.nih.gov/39142680