Clinical trial NCT01129700: Short-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer
Official title: Short-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Locally Advanced Rectal Cancer: Phase II Multi-institutional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rectal Cancer
Keywords: rectal cancer, short-course, chemoradiotherapy
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2010-05-25
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility 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

Primary outcomes:
measure: To evaluate the pathologic response
timeFrame: After surgery with pathology data
Secondary outcomes:
measure: Tumor regression grade & MR volumetry
timeFrame: After surgery with pathology data for TRG, at the pretreatment work-up and 1-4 days befor surgery
measure: Acute/ late toxicities
timeFrame: preoperative CCRT to 3 months after surgery
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center Korea
state: Gyeonggi-do
Study officials:
References: