Additional Chemotherapy After Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced 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

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rectal Cancer

Keywords

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rectal cancer neoadjuvant chemoradiotherapy Capecitabine

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Ji Yeon Kim

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ji Yeon Kim, MD., PhD

Role: PRINCIPAL_INVESTIGATOR

Surgical Oncology Research Lab

Locations

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Chungnam National University Hospital

Daejeon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CNUH 10

Identifier Type: -

Identifier Source: org_study_id