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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Tumor regression grading (TRG) — after completion of neoadjuvant treatment (up to 10 months) Histological response assessment by TRG (Werner / Hoefler et al.); Complete response is defined as TRG 1a;
Trial sites (1)
Facility
City
Region
Status
Department of Radiotherapy and Radiation Oncology, Jena University Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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