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Additional Chemotherapy After Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Rectal Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01671683
First Posted: August 23, 2012
Last Update Posted: August 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ji Yeon Kim, Chungnam National University
  Purpose
The aim of this study is to evaluate the efficacy and safety of additional neoadjuvant chemotherapy with capecitabine during the resting periods in patients with locally advanced rectal cancer.

Condition
Rectal Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Phase II Study of Additional Four-week Chemotherapy With Capecitabine During the Resting Periods After Six-week Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Rectal Cancer

Further study details as provided by Ji Yeon Kim, Chungnam National University:

Enrollment: 44
Study Start Date: July 2010
Study Completion Date: September 2011
Detailed Description:

Neoadjuvant chemoradiotherapy (NCRT) has been used as standard treatment modality in patients with locally advanced rectal cancer (LARC) because of increased local control, enhanced sphincter preservation, and less toxicity.NCRT has enhanced down-staging of tumor and reduced local recurrence. However, survival benefit of NCRT has not been demonstrated and the rate of distant metastasis was still reported as high as 30%.

Patients with pathologic complete remission (pCR) after NCRT have shown excellent survival benefit. We inferred that additional chemotherapy during the resting period could enhance the pCR rate. The aim of the present study is to evaluate the safety and efficacy of an additional 4-week chemotherapy with capecitabine after the conventional 6-week NCRT in patients with LARC.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients of our hospital
Criteria

Inclusion Criteria:

  • histologically proven, locally advanced adenocarcinoma of the rectum
  • an Eastern Cooperative Oncology Group (ECOG) score of 0-2
  • adequate function of major organs
  • a signed informed consent.

Exclusion Criteria:

  • other co-existing malignancy or malignancy within the last 5 years prior to enrollment
  • severe concurrent medical or psychiatric disorders
  • prior RT to pelvis
  • pregnant or lactating patients
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01671683


Locations
Korea, Republic of
Chungnam National University Hospital
Daejeon, Korea, Republic of, 301-721
Sponsors and Collaborators
Chungnam National University
Investigators
Principal Investigator: Ji Yeon Kim, MD., PhD Surgical Oncology Research Lab
  More Information

Responsible Party: Ji Yeon Kim, Associate Professor, Chungnam National University
ClinicalTrials.gov Identifier: NCT01671683     History of Changes
Other Study ID Numbers: CNUH 10
First Submitted: August 21, 2012
First Posted: August 23, 2012
Last Update Posted: August 23, 2012
Last Verified: August 2012

Keywords provided by Ji Yeon Kim, Chungnam National University:
rectal cancer
neoadjuvant chemoradiotherapy
Capecitabine

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents