Short-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01129700
• Other study ID #: NCCCTS-10-458
• Status: Completed
• Phase: Phase 2
• First received: May 13, 2010
• Last updated: April 25, 2012
• Start date: February 2010
• Est. completion date: February 2012

Study information

• Verified date: April 2012
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Concurrent chemoradiotherapy (CRT)

• Radiotherapy 25 ㏉/5 fractions (start concomitantly at D1)

• ↓ ↓ ↓ ↓ ↓

• Radical surgery 6 weeks after completion of chemoradiotherapy

• ↑ ↑ ↑ ↑ ↑ D1 - - - - - D5

• 5-Fluorouracil 400㎎/㎡/day + LV 20㎎/㎡/day IV bolus during the radiotherapy

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Radiation:
• Radiation: short-course preoperative chemoradiotherapy
Drug: 5-Fluorouracil 5-Fluorouracil is administered intravenously at a dose of 400 mg/m2 once daily continuous regimen during RT(5 days). Radiation: Localization, simulation and immobilization Radiation dose and planning Total dose 25Gy, 5 fractions (5 Gy/day).

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center Korea	Goyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the pathologic response	downstaging(ypT0-2N0M0)rate	After surgery with pathology data	No
Secondary	Tumor regression grade & MR volumetry	To evaluate the tumor regression grade & MR volumetry	After surgery with pathology data for TRG, at the pretreatment work-up and 1-4 days befor surgery	No
Secondary	Acute/ late toxicities	To evaluate the acute and late toxicities	preoperative CCRT to 3 months after surgery	Yes