Clinical trial · Interventional
Two-week Course Versus Conventionally Fractionated Chemoradiotherapy in Rectal Cancer
Two-Week COurse Versus Conventionally Fractionated Preoperative Chemoradiotherapy In Locally Advanced Rectal Cancer (TwoArc Trial): A Phase III Randomized Clinical Trial
NCT02484040CI-TRIAL-00027979unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrence | — | UNRESOLVED | — |
| Response to Toxin | — | UNRESOLVED | — |
| Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Two-week course of radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Two-week course 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
- interventionNames
- Radiation: Two-week course of radiation
- Drug: Two-week course of radiation
- type
- NO_INTERVENTION
- label
- Conventional 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
Primary outcomes (1)
- measure
- Tumor response from stage II-III to stage 0-I
- timeFrame
- from clinical staging time to radical surgery date (about 3 months)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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)
References
Publications (1)
- RESULTLee 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. PMID 24411228