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

NCT01129700 | Completed Phase 2

• 1 other identifier: NCCCTS-10-458
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Rectal Cancer

Keywords

rectal cancer, short-course, chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• To evaluate the pathologic response

  downstaging(ypT0-2N0M0)rate

  After surgery with pathology data

Secondary Outcomes (2)

• Tumor regression grade & MR volumetry

  After surgery with pathology data for TRG, at the pretreatment work-up and 1-4 days befor surgery

• Acute/ late toxicities

  preoperative CCRT to 3 months after surgery

Study Arms (1)

short-course CRT-5FU

EXPERIMENTAL

Radiation: Radiation: short-course preoperative chemoradiotherapy

Interventions

Radiation: short-course preoperative chemoradiotherapy RADIATION

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).

short-course CRT-5FU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center Korea

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 13, 2010
• First Posted: May 25, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: April 27, 2012

Record last verified: 2012-04

Locations

KR (1)