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

August 21, 2012
August 21, 2012
July 2010
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No Changes Posted
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Additional Chemotherapy After Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Rectal Cancer
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

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

patients of our hospital

Rectal Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
September 2011
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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
Both
20 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01671683
CNUH 10
No
Ji Yeon Kim, Chungnam National University
Chungnam National University
Not Provided
Principal Investigator: Ji Yeon Kim, MD., PhD Surgical Oncology Research Lab
Chungnam National University
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP