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A Phase Ⅱ Study of Pre-Operative Concurrent Chemoradiotherapy With Capecitabine Plus Irinotecan in Resectable Rectal Cancer.

Phase 2
18 Years
75 Years
Open (Enrolling)
Rectal Neoplasm, Neoadjuvant Therapy

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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

- 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:


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


Korea: Food and Drug Administration

Study ID:

NCCCTS 04-088



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