A Phase Ⅱ Study of Pre-Operative Concurrent Chemoradiotherapy With Capecitabine Plus Irinotecan in Resectable Rectal Cancer.
18 Years
75 Years
Both
Rectal Neoplasm, Neoadjuvant Therapy
Trial Information
A Phase Ⅱ Study of Pre-Operative Concurrent Chemoradiotherapy With Capecitabine Plus Irinotecan in Resectable Rectal Cancer.
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.
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the rectum
- Distal margin of tumor located from 0 to 8 cm from anal verge
- Tumor must be clinically resectable by surgery and R0 resection must be most likely
- ECOG performance status 0-2
- No prior chemotherapy, radiotherapy to pelvis, and immunotherapy
- Adequate organ functions
- Patients must sign an informed consent
Exclusion Criteria:
- Malignant disease of the rectum other than adenocarcinoma or arisen from chronic
inflammatory bowel disease
- Any unresected synchronous colon cancer
- Any distant metastasis
- Intestinal obstruction or impending obstruction, but decompressing colostomy is
permitted
- Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ
cancer of uterine cervix
- Any other morbidity or situation with contraindication for chemoradiotherapy
- Patients have history of significant gastric or small bowel resection, or
malabsorption syndrome, or other lack of integrity of the upper gastrointestinal
tract that may compromise the absorption of capecitabine
- Pregnant or lactating women or patients of childbearing potential not practicing
adequate contraception
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pathologic stage Tumor regression grade
Outcome Time Frame:
After operation
Principal Investigator
Kyung Hae Jung, M.D.
Investigator Role:
Principal Investigator
Authority:
Korea: Food and Drug Administration
Study ID:
NCCCTS 04-088
NCT ID:
NCT00506623
Start Date:
July 2004
Completion Date:
December 2008
Related Keywords:
- Rectal Neoplasm
- Neoadjuvant Therapy
- Rectal neoplasm
- Neoadjuvant therapy
- Radiotherapy
- Combination chemotherapy
- Irinotecan
- Capecitabine
- Neoplasms
- Rectal Neoplasms
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