No registrations found.
ID
Source
Brief title
Health condition
Locally advanced and recurrent rectal cancer
Sponsors and support
Quest Medical Imaging
KWF
Intervention
Outcome measures
Primary outcome
- The primary objective is based on the clinical benefit of FGOS combined with SGM-101 as the intraoperative imaging agent. The corresponding endpoint is the rate of patients with R0 resections.
Secondary outcome
- To determine the effect of FGOS combined with SGM-101 on intra-operative decision making. The corresponding endpoint is the clinical benefit at the patient level; a “positive” change in surgical plan or post-surgical management. Moreover, standard of care surgery will be compared to FGOS and assessing if the latter allowed to remove any additional histopathologically confirmed malignant lesions and/or to resect less non-malignant tissue.
- To determine the performance of SGM-101 in the intra-operative detection of rectal cancer. The corresponding endpoint will be the tumor-to-background ratio. In addition, the concordance between fluorescent signal and histopathologic results will be defined.
- To compare intra-operative fluorescence imaging with SGM-101 and histopathology. The corresponding endpoints will be the rate of false negatives, false positives, true negatives and true positives.
- To determine the changes in surgical planning due to FGOS combined with SGM-101 on mortality and postoperative complications caused by the surgical procedure. The corresponding endpoints are 30-day mortality and 30-day complication rates in order to substantiate the benefit/risk assessment of the use of SGM-101.
- To determine the effect of FGOS combined with SGM-101 on overall and disease-free survival, and to determine the effect on local recurrence rates. The corresponding endpoints will be the 2-year overall survival, 2-year disease-free survival and 2-year local recurrence free survival.
Background summary
This is a national phase III, multicenter, open label clinical trial on the performance of SGM-101, a fluorochrome-labeled anti-carcino-embryonic antigen (CEA) monoclonal antibody, for the delineation of locally advanced and recurrent rectal cancer. Patients will be followed for a total duration of two years postoperatively.
Study objective
The investigators hypothesize that the use of FGOS will increase the amount of R0 resections from 75 to 90% in locally advanced rectal cancer and from 50 to 70% in recurrent rectal cancer.
Study design
2 years post-treatment
Intervention
SGM-101, a fluorochrome-labeled anti-carcino-embryonic antigen (CEA) monoclonal antibody, for the delineation of locally advanced and recurrent rectal cancer
Inclusion criteria
1. Signed informed consent prior to any study-mandated procedure;
2. Patients aged over 18 years old;
3. 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 90 days after their last dose of study treatment.
4. 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)
5. Patients should be capable and willing to give informed consent before study specific procedures.
Exclusion criteria
1. Other malignancies, either currently or in the past five years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma.
2. Patients with a history of, or recently diagnosed with, peritoneal or distant metastasis (even those diagnosed during surgery)
3. Patient with a history of a clinically significant allergy.
4. Patients pregnant or breastfeeding lack of effective contraception in male or female patients with reproductive potential;
5. Laboratory abnormalities defined as:
a. Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the or;
b. Total bilirubin above 2 times the ULN or;
c. Serum creatinine above 1.5 times the ULN or;
d. Platelet count below 100 x 109/L or;
e. Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males);
f. 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;
6. Any condition that the investigator considers to be potentially jeopardizing the patients’ well-being or the study objectives.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7653 |
| CCMO | NL69838.058.19 |