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Preoperative Chemoradiotherapy With Capecitabine Plus Irinotecan in Rectal Cancer

Primary Purpose

Rectal Neoplasm, Neoadjuvant Therapy

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Capecitabine, Irinotecan

About this trial

This is an interventional treatment trial for Rectal Neoplasm focused on measuring Rectal neoplasm, Neoadjuvant therapy, Radiotherapy, Combination chemotherapy, Irinotecan, Capecitabine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

National Cancer Center Korea

Outcomes

Primary Outcome Measures

Pathologic stage Tumor regression grade

Secondary Outcome Measures

Toxicity

Full Information

NCT ID

NCT00506623

First Posted

July 23, 2007

Last Updated

July 23, 2007

Sponsor

National Cancer Center, Korea

1. Study Identification

Unique Protocol Identification Number

NCT00506623

Brief Title

Preoperative Chemoradiotherapy With Capecitabine Plus Irinotecan in Rectal Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2007

Overall Recruitment Status

Unknown status

Study Start Date

July 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

National Cancer Center, Korea

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rectal Neoplasm, Neoadjuvant Therapy

Keywords

Rectal neoplasm, Neoadjuvant therapy, Radiotherapy, Combination chemotherapy, Irinotecan, Capecitabine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Capecitabine, Irinotecan

Primary Outcome Measure Information:

Title

Pathologic stage Tumor regression grade

Time Frame

After operation

Secondary Outcome Measure Information:

Title

Toxicity

Time Frame

During chemoradiation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kyung Hae Jung, M.D.

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cancer Center Korea

City

Goyang

State/Province

Gyeonggi

ZIP/Postal Code

410-769

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Preoperative Chemoradiotherapy With Capecitabine Plus Irinotecan in Rectal Cancer

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