Capecitabine as Radiosensitising Agent in Neoadjuvant Treatment of Locally Advanced Resectable Rectal Cancer
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|ClinicalTrials.gov Identifier: NCT01152710|
Recruitment Status : Completed
First Posted : June 29, 2010
Last Update Posted : June 29, 2010
|Condition or disease||Intervention/treatment||Phase|
|Resectable Rectal Cancer Clinical Stage II and III||Drug: Capecitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Capecitabine as Radiosensitising Agent in Neoadjuvant Treatment of Locally Advanced Resectable Rectal Cancer|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||March 2006|
|Actual Study Completion Date :||April 2010|
- 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 weekendsOther Name: Xeloda
- complete pathological remission rate [ Time Frame: 9 weeks ]after pathological examination of resected specimen
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01152710
|Institute of Oncology|
|Ljubljana, Slovenia, 1000|