Assessment of Response Before, During and After Neoadjuvant Chemoradiotherapy in Rectal Cancer Patients
- Patient is at least 18 years of age.
- Patient's body weight is ≤ 120 kg.
- Histologically proven and evaluable (according to RECIST criteria) adenocarcinoma of
the rectum (tumour <15 cm from the anal verge), staged T3-4 N0 and T1-4N1-2.
- WHO PS ≤ 2
- Adequate bone marrow, hepatic and renal function (assessed within 14 days prior to
- Hemoglobin >10.0 g/dL,
- Absolute neutrophil count > 1.5 x 109/L,
- Platelet count > 100 x 109/L,
- Presence of adequate contraception in fertile patients. Adequate methods of
contraception are: intra-uterine device, hormonal contraception, condom use with
- Written informed consent must be given according to ICH/GCP and national/local
- Evidence of distant metastases.
- Prior chemotherapy or radiotherapy for rectal cancer.
- Pregnant or breastfeeding women.
- Significant impairment of intestinal resorption (e.g. chronic diarrhea, inflammatory
- Known allergies to intravenous contrast agents.
- Contra-indications for magnetic resonance imaging (metal implants, claustrophobia,
- Previous or concurrent malignancies at other sites with the exception of surgically
cured or adequately treated carcinoma in-situ of the cervix and non-melanoma skin
- History of uncontrolled seizures, central nervous system disorders or psychiatric
disability judged by the investigator to be clinically significant precluding
informed consent or interfering with compliance for oral drug intake.
- Presence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule;
those conditions should be discussed with the patient before registration in the