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

National Cancer Center (NCC)

Status and phase

Completed

Phase 2

Conditions

Rectal Cancer

Treatments

Radiation: Radiation: short-course preoperative chemoradiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCCCTS-10-458

Details and patient eligibility

About

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

Full 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.

Enrollment

73 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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