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Two-week Course Versus Conventionally Fractionated Chemoradiotherapy in Rectal Cancer

Primary Purpose

Response to Toxin, Toxicity, Recurrence

Status

Unknown status

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Two-week course of radiation

About this trial

This is an interventional treatment trial for Response to Toxin focused on measuring tumor response, toxicity, recurrence, chemoradiotherpy, rectum

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

histologically confirmed adenocarcinoma;
distal margin of the tumor located < 10 cm from the anal verge;
cT3-4N0-2 classification as determined by magnetic resonance imaging (MRI) and/or endorectal ultrasonography (EUS);
no evidence of distant metastasis;
Karnofsky performance score over 70;
adequate bone marrow, liver, and renal function (leucocytes >4000/mm3, hemoglobin >10 g/dL, platelets >100,000/mm3; serum bilirubin <1.5 mg/dL, serum transaminase <2.5 times the upper normal limit; serum creatinine <1.5 mg/dL).

Exclusion Criteria:

Metastatic disease
No complete resection of tumor (R2)

Sites / Locations

Lee Jong HoonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Two-week course arm

Conventional arm

Arm Description

Experimental arm receive 33 Gy in 10 fractions of radiation for 2 weeks with oral capecitabine. Two-week course of radiation, 33 Gy/10 fx and oral capecitabine, 825 mg/m2, bid

conventionally fractionated radiation of 50.4 Gy/28 fx and 5-FU, 500 mg/m2 and leucovorin, 20 mg/m2 for 5 days, monthly or Capecitabine, 825 mg/m2, bid

Outcomes

Primary Outcome Measures

Tumor response from stage II-III to stage 0-I

Downstaging rate was evaluated by comparing pre-clinical and post-CRT pathological stages, and downstaging was defined as ypStage 0-I (ypT0-2N0M0)

Secondary Outcome Measures

Toxicity (acute and chronic)

During the course of radiotherapy, patients were evaluated weekly to assess acute toxicity. Patients were also followed 2 and 4 weeks after completion of radiotherapy and until 3 years after curative surgery to assess toxicity. Toxicity are assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0).

Recurrence and survival

Full Information

NCT ID

NCT02484040

First Posted

June 17, 2015

Last Updated

June 1, 2017

Sponsor

Jong Hoon Lee

1. Study Identification

Unique Protocol Identification Number

NCT02484040

Brief Title

Two-week Course Versus Conventionally Fractionated Chemoradiotherapy in Rectal Cancer

Official Title

Two-Week COurse Versus Conventionally Fractionated Preoperative Chemoradiotherapy In Locally Advanced Rectal Cancer (TwoArc Trial): A Phase III Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Unknown status

Study Start Date

December 2015 (undefined)

Primary Completion Date

July 2019 (Anticipated)

Study Completion Date

July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jong Hoon Lee

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The investigators compare two-week course of chemoradiation (33 Gy in 10 fractions with oral capecitabine) and conventional chemoradiation (50.4 Gy in 28 fractions with 5-FU and leucovorin) in this randomized trial.

Detailed Description

1.1 experimental arm Two-week course concurrent chemoradiotherapy Radiotherapy, 33 Gy/10 fractions for 2 weeks ↓↓↓↓↓ ↓↓↓↓↓ Radical surgery 6 weeks after completion of chemoradiotherapy D1----------------------D12 Capecitabine 825 mg/m2, twice daily 1.2 control arm Standard concurrent chemoradiotherapy (CRT) Radiotherapy, 50.4 Gy/28 fractions for 6 weeks ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓ Radical surgery D1--------------------------------------------------------------------------D38 Bolus 5-FU, 400 mg/ m2 and leucovorin, 20 mg/ m2 during week 1 and 5 Capecitabine, 825 mg/ m2, bid

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Response to Toxin, Toxicity, Recurrence

Keywords

tumor response, toxicity, recurrence, chemoradiotherpy, rectum

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

370 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Two-week course arm

Arm Type

Experimental

Arm Description

Experimental arm receive 33 Gy in 10 fractions of radiation for 2 weeks with oral capecitabine. Two-week course of radiation, 33 Gy/10 fx and oral capecitabine, 825 mg/m2, bid

Arm Title

Conventional arm

Arm Type

No Intervention

Arm Description

conventionally fractionated radiation of 50.4 Gy/28 fx and 5-FU, 500 mg/m2 and leucovorin, 20 mg/m2 for 5 days, monthly or Capecitabine, 825 mg/m2, bid

Intervention Type

Radiation

Intervention Name(s)

Two-week course of radiation

Other Intervention Name(s)

experimental arm

Intervention Description

33 Gy in 10 fractions for 2 weeks

Intervention Type

Drug

Intervention Name(s)

Two-week course of radiation

Other Intervention Name(s)

experimental arm

Intervention Description

oral capecitabine, 825mg/m2, bid

Primary Outcome Measure Information:

Title

Tumor response from stage II-III to stage 0-I

Description

Downstaging rate was evaluated by comparing pre-clinical and post-CRT pathological stages, and downstaging was defined as ypStage 0-I (ypT0-2N0M0)

Time Frame

from clinical staging time to radical surgery date (about 3 months)

Secondary Outcome Measure Information:

Title

Toxicity (acute and chronic)

Description

Time Frame

from radiation start to 3 years after radical surgery

Title

Recurrence and survival

Time Frame

3-year recurrence-free survival and 3-year overall survival

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: histologically confirmed adenocarcinoma; distal margin of the tumor located < 10 cm from the anal verge; cT3-4N0-2 classification as determined by magnetic resonance imaging (MRI) and/or endorectal ultrasonography (EUS); no evidence of distant metastasis; Karnofsky performance score over 70; adequate bone marrow, liver, and renal function (leucocytes >4000/mm3, hemoglobin >10 g/dL, platelets >100,000/mm3; serum bilirubin <1.5 mg/dL, serum transaminase <2.5 times the upper normal limit; serum creatinine <1.5 mg/dL). Exclusion Criteria: Metastatic disease No complete resection of tumor (R2)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jong Hoon Lee, MD

Phone

+82-031-249-8440

koppul@catholic.ac.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jong Hoon Lee, MD

Organizational Affiliation

St. Vincent's Hospital, The Catholic University of Kora

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lee Jong Hoon

City

Suwon

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jong Hoon Lee

koppul@catholic.ac.kr

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

24411228

Citation

Lee JH, Kim JG, Oh ST, Lee MA, Chun HG, Kim DY, Kim TH, Kim SY, Baek JY, Park JW, Oh JH, Park HC, Choi DH, Park YS, Kim HC, Chie EK, Jang HS. Two-week course of preoperative chemoradiotherapy followed by delayed surgery for rectal cancer: a phase II multi-institutional clinical trial (KROG 11-02). Radiother Oncol. 2014 Jan;110(1):150-4. doi: 10.1016/j.radonc.2013.11.013. Epub 2014 Jan 7.

Results Reference

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Two-week Course Versus Conventionally Fractionated Chemoradiotherapy in Rectal Cancer

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