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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ji Yeon Kim, Chungnam National University
ClinicalTrials.gov Identifier:
NCT01671683
First received: August 21, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by 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

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ji Yeon Kim, Associate Professor, Chungnam National University
ClinicalTrials.gov Identifier: NCT01671683     History of Changes
Other Study ID Numbers: CNUH 10
Study First Received: August 21, 2012
Last Updated: August 21, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by 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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013