Clinical trial NCT02484040: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Response to Toxin
Toxicity
Recurrence
Keywords: tumor response
toxicity
recurrence
chemoradiotherpy
rectum
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2015-06-29
Enrollment: 370
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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)

Primary outcomes:
measure: Tumor response from stage II-III to stage 0-I
timeFrame: from clinical staging time to radical surgery date (about 3 months)
Secondary outcomes:
measure: Toxicity (acute and chronic)
timeFrame: from radiation start to 3 years after radical surgery
measure: Recurrence and survival
timeFrame: 3-year recurrence-free survival and 3-year overall survival
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Lee Jong Hoon
Study officials:
affiliation: St. Vincent's Hospital, The Catholic University of Kora
name: Jong Hoon Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.