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

18 Years
Not Enrolling
Adenocarcinoma, Rectal Neoplasms

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Trial Information

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

- Written informed consent must be given according to ICH/GCP and national/local

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

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Pathologic complete response (ypT0N0) rate

Outcome Time Frame:

6-8 weeks after the end of chemoradiotherapy

Safety Issue:


Principal Investigator

Karin Haustermans, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universitaire Ziekenhuizen Leuven


Belgium: Commissie Medische Ethiek van Universitaire Ziekenhuizen K.U.Leuven

Study ID:




Start Date:

October 2010

Completion Date:

October 2014

Related Keywords:

  • Adenocarcinoma
  • Rectal Neoplasms
  • staged T3-4 N0 and T1-4N1-2
  • adenocarcinoma of the rectum
  • rectum
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms
  • Rectal Neoplasms