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A Phase II Study of Pre-Operative Concurrent Chemoradiotherapy With Cetuximab, Irinotecan, and Capecitabine in Resectable Rectal Cancer

Phase 2
18 Years
75 Years
Open (Enrolling)
Rectal Neoplasms, Neoadjuvant Treatment

Thank you

Trial Information

A Phase II Study of Pre-Operative Concurrent Chemoradiotherapy With Cetuximab, Irinotecan, and Capecitabine in Resectable Rectal Cancer

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 are delivered concurrently
with chemotherapy.

Cetuximab 400 mg/m2 is given intravenously on D-6 (1 week before radiation), followed by 250
mg/m2 once a week (D 1, 8, 15, 22 & 29).

Administration of irinotecan and capecitabine starts on day 1 of radiotherapy. Capecitabine
is administered orally at a dose of 825 mg/m2 twice daily during weekdays (Monday to Friday)
during radiotherapy. Irinotecan 40 mg/m2 is given intravenously once a week (D 1, 8, 15, 22
& 29).

Four to eight weeks after completion of chemoradiotherapy, curative surgery is performed.

Safety evaluation of the study will be performed after the first 6 patients treated. If more
than 1 out of 6 patients received less than 70-80% of planned dose of capecitabine or
irinotecan, the dosage of chemotherapy in the further study patients will be adjusted by a
protocol amendment.

Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the rectum

- Distal margin of tumor located from 0 to 8 cm from anal verge

- Stage T3/T4 ± N+ by MRI ± endorectal ultrasonography

- ECOG performance status 0-2

- No prior chemotherapy, radiotherapy to pelvis, immunotherapy, and EGFR pathway
targeting therapy

- Adequate organ functions

- Patients must sign the informed consent

Exclusion Criteria:

- Malignant disease of the rectum other than adenocarcinoma or arisen from chronic
inflammatory bowel disease

- Any defined hereditary colorectal cancer

- Any unresected synchronous colon cancer

- R0 resection of tumor is not clinically possible

- 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 with 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

- History of severe pulmonary disease

- Pregnant or lactating women or patients of childbearing potential not predicting
adequate contraception

Type of Study:


Study Design:

Endpoint Classification: 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.Ph.D

Investigator Role:

Principal Investigator


Korea: Food and Drug Administration

Study ID:




Start Date:

May 2006

Completion Date:

May 2010

Related Keywords:

  • Rectal Neoplasms
  • Neoadjuvant Treatment
  • Rectal neoplasms
  • Neoadjuvant treatment
  • Cetuximab
  • Irinotecan
  • Capecitabine
  • Radiotherapy
  • Combination chemotherapy
  • Neoplasms
  • Rectal Neoplasms