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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


N/A
20 Years
90 Years
Not Enrolling
Both
Rectal Cancer

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

Ji Yeon Kim, MD., PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Surgical Oncology Research Lab

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

CNUH 10

NCT ID:

NCT01671683

Start Date:

July 2010

Completion Date:

September 2011

Related Keywords:

  • Rectal Cancer
  • rectal cancer
  • neoadjuvant chemoradiotherapy
  • Capecitabine
  • Rectal Neoplasms

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