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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01152710
First Posted: June 29, 2010
Last Update Posted: June 29, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Institute of Oncology Ljubljana
June 25, 2010
June 29, 2010
June 29, 2010
June 2004
March 2006   (Final data collection date for primary outcome measure)
complete pathological remission rate [ Time Frame: 9 weeks ]
after pathological examination of resected specimen
Same as current
No Changes Posted
  • the rate of sphincter preservation in low-sited tumours [ Time Frame: 9 weeks ]
    after the operation
  • toxicity of combined modality treatment (Number of Participants with Adverse Events) [ Time Frame: 5 weeks ]
    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 ]
    after the pathological examination of resected specimen
  • overall survival [ Time Frame: 5 years ]
    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 ]
    Local control is defined as the time from inclusion to the date of local recurrence
  • relapse-free survival [ Time Frame: 5 years ]
    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 ]
Same as current
Not Provided
Not Provided
 
Capecitabine as Radiosensitising Agent in Neoadjuvant Treatment of Locally Advanced Resectable Rectal Cancer
Capecitabine as Radiosensitising Agent in Neoadjuvant Treatment of Locally Advanced Resectable Rectal Cancer
A Phase II study aimed to evaluate the efficacy and toxicity of preoperative chemoradiotherapy with capecitabine in locally advanced resectable rectal cancer.
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.
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Resectable Rectal Cancer Clinical Stage II and III
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
April 2010
March 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Slovenia
 
 
NCT01152710
139/03/06
No
Not Provided
Not Provided
Prof.assist. Vaneja Velenik, MD, PhD, Institute of Oncology
Institute of Oncology Ljubljana
Not Provided
Not Provided
Institute of Oncology Ljubljana
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP