Clinical trial NCT00506844: Preoperative Chemoradiotherapy With Cetuximab in Rectal Cancer
Official title: A Phase II Study of Pre-Operative Concurrent Chemoradiotherapy With Cetuximab, Irinotecan, and Capecitabine in Resectable Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rectal Neoplasms
Neoadjuvant Treatment
Keywords: Rectal neoplasms
Neoadjuvant treatment
Cetuximab
Irinotecan
Capecitabine
Radiotherapy
Combination chemotherapy
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2007-07-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pathologic stage Tumor regression grade
timeFrame: After operation
Secondary outcomes:
measure: Toxicity measured by NCICTC v3
timeFrame: During chemoradiation
measure: Disease-free survival
timeFrame: Three year
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center Korea
state: Gyeonggi
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
name: Kyung Hae Jung, M.D.Ph.D
role: PRINCIPAL_INVESTIGATOR
References: