Two-week Course Versus Conventionally Fractionated Chemoradiotherapy in Rectal Cancer

Recurrence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02484040
• Other study ID #: TwoArc trial
• Status: Recruiting
• Phase: Phase 3
• First received: June 17, 2015
• Last updated: June 1, 2017
• Start date: December 2015
• Est. completion date: July 2021

Study information

• Verified date: June 2017
• Source: Seoul St. Mary's Hospital
• Contact: Jong Hoon Lee, MD
• Phone: +82-031-249-8440
• Email: koppul[@]catholic.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 370
• Est. completion date: July 2021
• Est. primary completion date: July 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. histologically confirmed adenocarcinoma;

2. distal margin of the tumor located < 10 cm from the anal verge;

3. cT3-4N0-2 classification as determined by magnetic resonance imaging (MRI) and/or endorectal ultrasonography (EUS);

4. no evidence of distant metastasis;

5. Karnofsky performance score over 70;

6. 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:

1. Metastatic disease

2. No complete resection of tumor (R2)

Related Conditions & MeSH terms

• Rectal Neoplasms
• Recurrence
• Response to Toxin
• Toxicity

Intervention

Radiation:
• Two-week course of radiation
33 Gy in 10 fractions for 2 weeks

Drug:
• Two-week course of radiation
oral capecitabine, 825mg/m2, bid

Locations

Country	Name	City	State
Korea, Republic of	Lee Jong Hoon	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Jong Hoon Lee

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	from clinical staging time to radical surgery date (about 3 months)
Secondary	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).	from radiation start to 3 years after radical surgery
Secondary	Recurrence and survival		3-year recurrence-free survival and 3-year overall survival