Capecitabine as Radiosensitising Agent in Neoadjuvant Treatment of Locally Advanced Resectable Rectal Cancer

This study has been completed.
Information provided by:
Institute of Oncology Ljubljana Identifier:
First received: June 25, 2010
Last updated: June 28, 2010
Last verified: June 2010
A Phase II study aimed to evaluate the efficacy and toxicity of preoperative chemoradiotherapy with capecitabine in locally advanced resectable rectal cancer.

Condition Intervention Phase
Resectable Rectal Cancer Clinical Stage II and III
Drug: Capecitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Capecitabine as Radiosensitising Agent in Neoadjuvant Treatment of Locally Advanced Resectable Rectal Cancer

Resource links provided by NLM:

Further study details as provided by Institute of Oncology Ljubljana:

Primary Outcome Measures:
  • complete pathological remission rate [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    after pathological examination of resected specimen

Secondary Outcome Measures:
  • the rate of sphincter preservation in low-sited tumours [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    after the operation

  • toxicity of combined modality treatment (Number of Participants with Adverse Events) [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
    During preoperative treatment, patients will be evaluated weekly for acute toxicity and compliance with the protocol. Clinical examination and complete blood count will be performed and body weight was measured. Toxic side effects will be assessed according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) (version 2.0). Patients will be followed every three month for the first two years after the last cycle of adjuvant chemotherapy and thereafter every six month up to 5th year.

  • overall downstaging rate [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    after the pathological examination of resected specimen

  • overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Overall survival is defined as the time from inclusion to the date of death from any cause or to the date of last follow-up.

  • local control [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Local control is defined as the time from inclusion to the date of local recurrence

  • relapse-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Relapse-free survival iss defined as the time from inclusion to the first occurrence of disease relapse (local or distant), death or date of last follow-up.

  • long-term rectal and urogenital morbidity [ Time Frame: 2 years after the surgery ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: June 2004
Study Completion Date: April 2010
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Capecitabine
    Chemotherapy with capecitabine of 1650 mg/m2 daily dose will be administered orally, divided into two equal doses given 12 hours apart, during radiotherapy(45 Gy 1,8 Gy/fr), including weekends
    Other Name: Xeloda
Detailed Description:
Preoperative chemoradiation has become a standard part of treatment protocols in stage II and III rectal cancer. Compared to postoperative chemoradiotherapy, the advantage of preoperative application of chemotherapeutics and irradiation includes improved compliance, reduced toxicity and downstaging of the tumour in a substantial number of patients. The latter may enhance the rate of curative surgery, permit sphincter preservation in patients with low-sited tumours and have a positive impact on the quality of life of these patients. Orally administered capecitabine (Xeloda®, Hoffmann - La Roche Ltd, Basel, Switzerland) mimics the pharmacokinetics of continuous 5-FU infusion and makes chemoradiotherapy more patient-friendly. The mechanism of capecitabine activation, preferably in tumour cells, may further enhance its efficacy and tolerability, offering the potential for an enhanced therapeutic ratio.The aim of the present phase II study was to evaluate the efficacy and toxicity of preoperative chemoradiotherapy with capecitabine in patients with locally advanced rectal cancer. The primary endpoint of the study is a pathologically determined complete remission rate (pCR) of the disease locally and regionally. Secondly, the rate of sphincter preservation in low-sited tumours, overall downstaging rate,toxicity and survival parameters will be analysed.

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • histologically verified adenocarcinoma of the rectum,
  • resectable clinical stage II or III (IUCC TNM classification 2002);
  • no prior radiotherapy and/or chemotherapy;
  • World Health Organisation (WHO) performance status < 2;
  • age at diagnosis of 18 or older;
  • and adequate bone marrow, liver, renal and cardiac function (no history of ischemic heart disease).

Exclusion Criteria:

  • A history of prior malignancy other than non-melanoma skin cancer or in situ carcinoma of the cervix
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Please refer to this study by its identifier: NCT01152710

Institute of Oncology
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
Institute of Oncology Ljubljana
  More Information


Responsible Party: Prof.assist. Vaneja Velenik, MD, PhD, Institute of Oncology Identifier: NCT01152710     History of Changes
Other Study ID Numbers: 139/03/06 
Study First Received: June 25, 2010
Last Updated: June 28, 2010
Health Authority: Slovenia: Ministry of Health

Keywords provided by Institute of Oncology Ljubljana:
rectal cancer
phase II study

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases
Antimetabolites, Antineoplastic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 22, 2016