SGM-101 in Locally Advanced and Recurrent Rectal Cancer
NCT ID: NCT04642924
Last Updated: 2020-11-24
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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UNKNOWN
PHASE2/PHASE3
203 participants
INTERVENTIONAL
2019-10-22
2023-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Locally Advanced Rectal Cancer
Patients included with locally advanced rectal cancer SGM-101 10mg, 3-5 days prior to surgery
SGM-101
Fluorescence-guided surgery
Recurrent rectal cancer
Patients included with (locally) recurrent rectal cancer SGM-101 10mg, 3-5 days prior to surgery
SGM-101
Fluorescence-guided surgery
Interventions
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SGM-101
Fluorescence-guided surgery
Eligibility Criteria
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Inclusion Criteria
2. All women of child bearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception for at least 30 days after their last dose of study treatment.
3. Patients should be scheduled and eligible for surgery because of a clinical diagnosis of T3 with a threatened CRM or T4 rectal cancer (locally advanced) or recurrent rectal cancer. (UICC. TNM classification of diseases for oncology. 3rd ed. Geneva: World Health Organization; 2000)
4. Patients should be capable and willing to give signed informed consent before study specific procedures.
Exclusion Criteria
2. Patients with a history of, or recently diagnosed with, peritoneal metastases (even those diagnosed during surgery)
3. Patients with a recent history (within the last 3 years) of other distant metastases (even those diagnosed during surgery)
4. Patient with a history of a clinically significant allergy.
5. Patients pregnant or breastfeeding lack of effective contraception in male or female patients with reproductive potential;
6. Laboratory abnormalities defined as:
1. Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the or;
2. Total bilirubin above 2 times the ULN or;
3. Serum creatinine above 1.5 times the ULN or;
4. Platelet count below 100 x 109/L or;
5. Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males);
6. Known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody or patients with untreated serious infections;
7. Any condition that the investigator considers to be potentially jeopardizing the patients' well-being or the study objectives.
8. Previous administration of SGM-101
18 Years
ALL
No
Sponsors
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Erasmus Medical Center
OTHER
Amsterdam UMC, location VUmc
OTHER
Catharina Ziekenhuis Eindhoven
OTHER
Medical Center Haaglanden
OTHER
Surgimab
INDUSTRY
Quest Medical Imaging
INDUSTRY
Centre for Human Drug Research, Netherlands
OTHER
Leiden University Medical Center
OTHER
Responsible Party
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Alexander Vahrmeijer
Principal Investigator
Locations
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Amsterdam University Medical Center
Amsterdam, , Netherlands
Catharina Hospital Eindhoven
Eindhoven, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
Haaglanden Medisch Centrum
The Hague, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Miranda Kusters
Role: primary
Harm Rutten
Role: primary
Kees Verhoef
Role: primary
Andreas Marinelli
Role: primary
Other Identifiers
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L19-069
Identifier Type: -
Identifier Source: org_study_id