Actively Recruiting
Induction Chemotherapy for Locally Recurrent Rectal Cancer
Led by Catharina Ziekenhuis Eindhoven · Updated on 2022-09-06
364
Participants Needed
14
Research Sites
485 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicentre, open-label, parallel arms, phase IIII study that randomises patients with locally recurrent rectal cancer in a 1:1 ratio to receive either induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery (experimental arm) or neoadjuvant chemoradiotherapy and surgery alone (control arm)
CONDITIONS
Official Title
Induction Chemotherapy for Locally Recurrent Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Confirmed locally recurrent rectal cancer after total or partial mesorectal resection for rectal or distal sigmoidal cancer by histopathology or clinical evidence with imaging and MDT consensus
- Resectable disease determined by MRI or deemed resectable after neoadjuvant chemoradiotherapy
- WHO performance score 0-1
- Written informed consent
You will not qualify if you...
- Radiological evidence of metastatic disease at randomisation or within 6 months prior
- Known homozygous DPD deficiency
- Any chemotherapy in the past 6 months
- Contraindication for planned chemotherapy as assessed by medical oncologist
- Radiotherapy in the past 6 months for primary rectal cancer
- Contraindication for planned chemoradiotherapy as assessed by medical or radiation oncologist
- Contraindication for surgery as assessed by surgeon or anaesthesiologist
- Concurrent malignancies interfering with study treatment or prognosis of resected locally recurrent rectal cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
UZ Gent
Ghent, Belgium
Not Yet Recruiting
2
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
3
Antoni van Leeuwenhoek
Amsterdam, Netherlands
Actively Recruiting
4
Catharina Hospital
Eindhoven, Netherlands, 5623EJ
Actively Recruiting
5
University Medical Centre Groningen
Groningen, Netherlands
Actively Recruiting
6
Leids University Medical Centre
Leiden, Netherlands
Actively Recruiting
7
Haaglanden Medical Centre
Leidschendam, Netherlands
Actively Recruiting
8
Maastricht University Medical Centre
Maastricht, Netherlands
Actively Recruiting
9
Erasmus Medical Centre
Rotterdam, Netherlands
Actively Recruiting
10
Oslo Universitetssykehus
Oslo, Norway
Not Yet Recruiting
11
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.
Lisbon, Portugal
Not Yet Recruiting
12
Sahlgrenska Universitetssjukhuset
Gothenburg, Sweden
Not Yet Recruiting
13
Skåne Universitetssjukhuset
Malmö, Sweden
Not Yet Recruiting
14
Karolinska Universitetssjukhuset
Stockholm, Sweden
Not Yet Recruiting
Research Team
S
Stefi Nordkamp, MD
CONTACT
F
Floor Piqeur, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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