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Short-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer: Phase II Multi-institutional Study


Phase 2
18 Years
N/A
Not Enrolling
Both
Rectal Cancer

Thank you

Trial Information

Short-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer: Phase II Multi-institutional Study


Radiotherapy using tomotherapy is delivered in 5 Gy daily fractions for a total of 25 Gy in
5 fractions.

A bolus injection of 5-fluorouracil (400 mg/m2/d)and leucovorin (20 mg/m2/d) is delivered
concurrently on day 1-5 during radiotherapy.

Total mesorectal excision is performed within 6±2 weeks. The pathological response of
downstaing is the study endpoint.

Inclusion Criteria


Inclusion Criteria :

- Pathologically proven diagnosis of adenocarcinoma of the rectum (located within 8㎝
above the anal verge)

- Locally advanced and curatively resectable tumor(cT3-4 classification) evaluated with
magnetic resonance imaging(MRI) with or without transrectal ultrasonography(TRUS)

- Age ≥18

- Performance Status(ECOG) 0-2

- CBC/differential obtained within 14 days prior to registration on study, with
adequate bone marrow function defined as follows: Hemoglobin ≥ 10 g/dl, Absolute
neutrophil count(ANC) ≥ 1,500 cells/㎣, Platelets ≥ 100,000cells/㎣

- Metabolic panel within 14 days prior to registration on study, with adequate liver
and renal function defined as follows: AST and ALT ≤ 60 IU/L, bilirubin ≤ 1.5 mg/dl,
serum creatinine ≤ 1.5 mg/dl

- Patient must provide study-specific informed consent prior to study entry

Exclusion Criteria :

- Any evidence of distant metastases(M1)

- Prior invasive malignancy (except non-melanomatous skin cancer and uterine cervical
cancer in situ) unless disease free to a minimum of 3 years

- Hereditary rectal cancer; Familial adenomatous polyposis(FAP), Hereditary
non-polyposis colorectal cancer(HNPCC), etc.

- Impending obstruction (except the case with colostomy)

- Severe, active comorbidity inappropriate to CRT as follows; Acute bacterial or fungal
infection, transmural myocardial infarction within the last 6 months, unstable
arrhythmia, angina and/or congestive heart failure, unstable arrhythmia

- Pregnancy or women of childbearing potential who are sexually active and not
willing/able to use medically acceptable forms of contraception

- Unresected synchronous colon carcinoma

- Clinically unresectable rectal cancer

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the pathologic response

Outcome Description:

downstaging(ypT0-2N0M0)rate

Outcome Time Frame:

After surgery with pathology data

Safety Issue:

No

Authority:

Korea: Institutional Review Board

Study ID:

NCCCTS-10-458

NCT ID:

NCT01129700

Start Date:

February 2010

Completion Date:

February 2012

Related Keywords:

  • Rectal Cancer
  • rectal cancer, short-course, chemoradiotherapy
  • Rectal Neoplasms

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