Preoperative Chemoradiotherapy With Capecitabine Plus Irinotecan in Rectal Cancer
|ClinicalTrials.gov Identifier: NCT00506623|
Recruitment Status : Unknown
Verified July 2007 by National Cancer Center, Korea.
Recruitment status was: Active, not recruiting
First Posted : July 25, 2007
Last Update Posted : July 25, 2007
|Condition or disease||Intervention/treatment||Phase|
|Rectal Neoplasm Neoadjuvant Therapy||Drug: Capecitabine, Irinotecan||Phase 2|
This study is an open-label, single center, nonrandomized phase II study. Daily fractions of radiotherapy at 1.8 Gy to total of 45 Gy to tumor and draining lymph nodes and followed by a coned-down boost of 5.4 Gy to the tumor were delivered concurrently with chemotherapy.
Chemotherapy starts at day 1 of radiotherapy. Capecitabine is administered orally at a dose of 825 mg/m2 twice daily during weekdays (Monday to Friday) every week during radiotherapy. Irinotecan 40 mg/m2 is given intravenously once a week (D 1, 8, 15, 22 & 29).
Six ± 2 weeks after completion of chemoradiotherapy, curative surgery is performed.
Post-operative chemotherapy with capecitabine will be given to all patients 3-6 weeks after surgery. Capecitabine 1,250 mg/m2 twice daily on days 1-14 every 21 days will be administered for 18 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ⅱ Study of Pre-Operative Concurrent Chemoradiotherapy With Capecitabine Plus Irinotecan in Resectable Rectal Cancer.|
|Study Start Date :||July 2004|
|Estimated Study Completion Date :||December 2008|
- Pathologic stage Tumor regression grade [ Time Frame: After operation ]
- Toxicity [ Time Frame: During chemoradiation ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00506623
|Korea, Republic of|
|National Cancer Center Korea|
|Goyang, Gyeonggi, Korea, Republic of, 410-769|
|Principal Investigator:||Kyung Hae Jung, M.D.|