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Trial Title:
Longitudinal Multimodal Response Assessment During Neoadjuvant Treatment of Rectal Cancer
NCT ID:
NCT05524012
Condition:
Locally Advanced Rectal Carcinoma
Neoadjuvant Treatment
Radiotherapy
Adaptive Treatment
Conditions: Official terms:
Rectal Neoplasms
Conditions: Keywords:
total neoadjuvant therapy (TNT)
T2* MRI
circulating tumor cells
tumor infiltrating lymphocytes
liquid biopsy
DWI
rectal cancer
organ preservation
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Blood sample
Description:
longitudinal blood samples for CTC monitoring
Other name:
analyses of circulating tumor cells (CTC)
Intervention type:
Device
Intervention name:
MRI scan
Description:
longitudinal MRI scans (non-contrast enhanced)
Other name:
multiparametric (incl. DWI and T2* "BOLD")
Summary:
This pilot study aims to trial multimodal early response assessment to enable therapy
adaptions in the context of non-operative therapy strategies of locally advanced rectal
cancer (LARC) for development of a non-invasive response prediction model.
Detailed description:
Patients with LARC, receiving neoadjuvant chemoradiotherapy (CRT) are followed by at
least 4 multiparametric MRI-scans (diffusion weighted imaging and hypoxia-sensitive
sequences) as well as repeated blood samples in order to analyse circulating tumour cells
(CTCs). A standard pelvis radiotherapy (RT, 5040 cGy) will be performed in combination
with a 5-Fluorouracil / Oxaliplatin regimen in all patients (planned: N = 50), succeeded
by consolidation CTx (FOLFOX4) if feasible. Additional histologic markers, such as
tumour-infiltrating lymphocytes (TILs) or PD-L1 status will be analysed before and after
CRT. Resection is standard after completion of preoperative treatment. In case of
complete regression and patient's request, a non-operative management ("watch and wait")
is offered alternatively. The primary endpoint is response, defined by tumor regression
grading, secondary endpoints comprise longitudinal changes in MRI as well as in CTCs and
TILs.
Criteria for eligibility:
Study pop:
Patients with locally advanced rectal cancer (LARC), receiving neoadjuvant
chemoradiotherapy (CRT).
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- locally advanced rectal cancer (LARC): UICC Stage II/III
- no severe cardiac or lung disease
- no severe hepatic disorders (liver enzymes <2.5 NR) or restrictions of renal
function (GFR > 30ml/min)
- no severe cytopenia (Neutrocytes >= 3 Gpt/l; Thrombocytes >= 100 Gpt/l; Hemoglobin
>6mmol/l)
- no homozygotic DPD deficiency
- no other neoplasms requiring therapy
- no earlier radiotherapy of the pelvis or earlier chemotherapy
- no contraindications for MRI
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Radiotherapy and Radiation Oncology, Jena University Hospital
Address:
City:
Jena
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Georg Wurschi, MD
Email:
georg.wurschi@med.uni-jena.de
Start date:
November 30, 2022
Completion date:
September 30, 2030
Lead sponsor:
Agency:
Jena University Hospital
Agency class:
Other
Source:
Jena University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05524012
