Preoperative Chemoradiotherapy With Capecitabine Plus Irinotecan in Rectal Cancer

Neoadjuvant Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00506623
• Other study ID #: NCCCTS 04-088
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 23, 2007
• Last updated: July 23, 2007
• Start date: July 2004
• Est. completion date: December 2008

Study information

• Verified date: July 2007
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate the pathologic complete response rate to pre-operative concurrent chemoradiotherapy with capecitabine plus irinotecan in resectable rectal cancer

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoadjuvant Therapy
• Rectal Neoplasm
• Rectal Neoplasms

Intervention

Drug:
• Capecitabine, Irinotecan

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center Korea	Goyang	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic stage Tumor regression grade		After operation
Secondary	Toxicity		During chemoradiation