Assessment of Response Before, During and After Neoadjuvant Chemoradiotherapy in Rectal Cancer Patients

Inclusion criteria

• 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 study entry):
• 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 spermicide.
• Written informed consent must be given according to ICH/GCP and national/local regulations.

Exclusion criteria

• 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 bowel disease).
• Known allergies to intravenous contrast agents.
• Contra-indications for magnetic resonance imaging (metal implants, claustrophobia, etc. ).
• 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 cancer.
• 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 trial.