Induction Chemotherapy Radiochemotherapy Consolidation Chemotherapy in Preoperative Treatment of Rectal Cancer

  • participants needed
  • sponsor
    Institute of Oncology Ljubljana
Updated on 8 November 2020
renal function
adenocarcinoma of rectum
total mesorectal excision


The use of capecitabine based preoperative chemoradiation and adjuvant chemotherapy is standard treatment of locally advanced rectal cancer. It has reduced local recurrence rate to less than 10%, but has only had limited effect on overall survival due to the constantly high (more than 30%) rate of distant metastasis.

Complete eradication of the primary tumour observed in the histopathological specimen (pathological complete response, pCR) correlates with a favourable overall prognosis so obtaining a pCR might be beneficial. The aim of the study is to investigate whether the addition of capecitabine based chemotherapy before preoperative chemoradiation and also before the operation improves pathological complete remission rate in locally advanced rectal cancer with acceptable toxicity. Secondary objectives are to evaluate pathological downstaging rate, histopathological R0 resection rate,sphincter preservation rate, perioperative surgical complication rate, local control, DFS, OS, late toxicity and quality of life.

Condition Rectal Cancer
Treatment intensified preoperative chemotherapy
Clinical Study IdentifierNCT01489332
SponsorInstitute of Oncology Ljubljana
Last Modified on8 November 2020


Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Rectal Cancer?
Male or female patients with histologically proven adenocarcinoma of the rectum (tumour located below the peritoneum)
T3/4 or any node positive disease (clinical stage according the TNM classification system)
No evidence of metastatic disease
The disease must be considered either resectable at the time of entry or thought to become resectable after preoperative chemoradiation
Age 18 years and more
WHO Performance Status 0-2
No prior radiotherapy, chemotherapy or any targeting therapy for rectal cancer
Adequate hematological, hepatic and renal function Ability to swallow tablets
Signed informed consent
Patients must be willing and able to comply with the protocol for duration of the study

Exclusion Criteria

Malignancy of the rectum other than adenocarcinoma
Any unrested synchronous colon cancer
Other co-existing malignancy or malignancy within the past 5 years, with the exception of adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin
Significant heart disease (uncontrolled hypertension despite of medication (> 150/100 mmHg), NYHA class III or IV heart disease,unstable angina or myocardial infarction within the past 1 year prior the study entry, history of significant ventricular arrhythmia requiring treatment)
Pregnant or lactating patient
Females with a positive or no pregnancy test unless childbearing potential can be otherwise excluded (amenorrheic for at least 2 years,hysterectomy or oophorectomy)
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