Neoadjuvant Therapy, Rectal Neoplasm
Conditions
Keywords
Rectal neoplasm, Neoadjuvant therapy, Radiotherapy, Combination chemotherapy, Irinotecan, Capecitabine
Brief summary
This study is to evaluate the pathologic complete response rate to pre-operative concurrent chemoradiotherapy with capecitabine plus irinotecan in resectable rectal cancer
Detailed description
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.
Interventions
DRUGCapecitabine, Irinotecan
Sponsors
National Cancer Center, Korea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic stage Tumor regression grade | After operation |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity | During chemoradiation |
Countries
South Korea
Outcome results
None listed