Preoperative Chemoradiotherapy With Capecitabine Plus Irinotecan in Rectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2008-12-31

Brief Summary

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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

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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.

Conditions

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Rectal Neoplasm Neoadjuvant Therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Capecitabine, Irinotecan

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Kyung Hae Jung, M.D.

Role: PRINCIPAL_INVESTIGATOR

Locations

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National Cancer Center Korea

Goyang-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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NCCCTS 04-088

Identifier Type: -

Identifier Source: org_study_id