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Preoperative Chemoradiotherapy With Capecitabine Plus Irinotecan in Rectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by National Cancer Center, Korea.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT00506623
First received: July 23, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  Purpose

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


Condition Intervention Phase
Rectal Neoplasm
Neoadjuvant Therapy
 Drug: Capecitabine, Irinotecan
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase Ⅱ Study of Pre-Operative Concurrent Chemoradiotherapy With Capecitabine Plus Irinotecan in Resectable Rectal Cancer.

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • Pathologic stage Tumor regression grade [ Time Frame: After operation ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: During chemoradiation ]

Enrollment: 48
Study Start Date: July 2004
Estimated Study Completion Date: December 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00506623

Locations
Korea, Republic of
National Cancer Center Korea
Goyang, Gyeonggi, Korea, Republic of, 410-769
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Kyung Hae Jung, M.D.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00506623     History of Changes
Other Study ID Numbers: NCCCTS 04-088
Study First Received: July 23, 2007
Last Updated: July 23, 2007
Health Authority: Korea: Food and Drug Administration

Keywords provided by National Cancer Center, Korea:
Rectal neoplasm
Neoadjuvant therapy
Radiotherapy
 Combination chemotherapy
Irinotecan
Capecitabine

Additional relevant MeSH terms:
Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
Capecitabine
Fluorouracil
 Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 21, 2013