Longitudinal Multimodal Response Assessment During Neoadjuvant Treatment of Rectal Cancer

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05524012

Studienbeginn:
November 2022

Letztes Update:
15.03.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Rectal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Jena University Hospital

Collaborator:
-

Studienleiter

Andrea Wittig-Sauerwein, MD
Principal Investigator
Department for Radiotherapy and Radiooncology, Jena University Hospital

Kontakt

Georg Wurschi, MD
Kontakt:
Phone: +49 3641 9 32 84 16
E-Mail: georg.wurschi@med.uni-jena.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Department of Radiotherapy and Radiation Oncology, Jena University Hospital
Jena
(Thüringen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Georg Wurschi, MD
E-Mail: georg.wurschi@med.uni-jena.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Tumor regression grading (TRG) (Time Frame - after completion of neoadjuvant treatment (up to 10 months)):
Histological response assessment by TRG (Werner / Hoefler et al.); Response is defined as TRG 1a/b/2;

Secondary outcome:

1. MRI (Time Frame - up to 10 months, until resection):
longitudinal changes in multiparametric MRI sequences (diffusion weighted and hypoxia sensitive)

2. Circulating Tumor Cells (CTC) (Time Frame - 5 years):
longitudinal changes in CTCs

3. Tumor Infiltrating Lymphocytes (TIL) (Time Frame - up to 10 months, until resection):
longitudinal changes in TILs

4. PFS (Time Frame - 5 years):
progression free survival

5. OS (Time Frame - 5 years):
overall survival

6. Surrogate marker: Interleukin 6 (IL-6) (Time Frame - 5 years):
surrogates of tumor and inflammation from routine blood draws [ng/l]

7. Surrogate marker: Carcinoembryonic Antigen (CEA) (Time Frame - 5 years):
surrogates of tumor and inflammation from routine blood draws, [mg/l]

Geprüfte Regime

Blood sample (analyses of circulating tumor cells (CTC)):
longitudinal blood samples for CTC monitoring
MRI scan (multiparametric (incl. DWI and T2* "BOLD")):
longitudinal MRI scans (non-contrast enhanced)

Quelle: ClinicalTrials.gov

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