Preoperative Chemoradiotherapy With Cetuximab in Rectal Cancer (ERBIRIX)

National Cancer Center (NCC)

Status and phase

Unknown

Phase 2

Conditions

Neoadjuvant Treatment

Rectal Neoplasms

Treatments

Drug: Cetuximab, Irinotecan, Capecitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT00506844

NCCCTS-06-165

Details and patient eligibility

About

This study is to estimate the pathologic complete response rate of cetuximab, irinotecan, and capecitabine concurrent with radiotherapy given preoperatively in patients with resectable rectal cancer.

Full description

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.

Enrollment

40 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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 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 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