Short-course Preoperative Chemoradiotherapy Followed by D... | NCT01129700

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

NCT01129700

Sponsor

National Cancer Center, Korea

Status

Completed

Last Update Posted

Apr 27, 2012Estimated

Enrollment

73Actual

Phase

Phase 2

Conditions

Rectal Cancer

Interventions

Radiation: short-course preoperative chemoradiotherapy

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Feb 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

May 13, 2010

First Submission Date that Met QC Criteria

May 24, 2010

First Posted Date

May 25, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2012

Last Update Posted Date

Apr 27, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

73Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
short-course CRT-5FU	Experimental		Radiation: Radiation: short-course preoperative chemoradiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the pathologic response	downstaging(ypT0-2N0M0)rate	After surgery with pathology data

Secondary Outcomes

Measure	Description	Time Frame
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
Acute/ late toxicities

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms