Symptoms and General Pathology

All Conditions

Recurrence

Disease Attributes

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Capecitabine

Leucovorin

Fluorouracil

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

Two-week course of radiation

Jong Hoon Lee, MD

Jong Hoon Lee

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.

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

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

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

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).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Two-week Course Versus Conventionally Fractionated Chemoradiotherapy in Rectal Cancer	NCT02484040	Response to Tox... Toxicity Recurrence	Two-week course... Two-week course...	20 Years - 80 Years	Seoul St. Mary's Hospital
Two-week Course Versus Conventionally Fractionated Chemoradiotherapy in Rectal Cancer	NCT02484040	Response to Tox... Toxicity Recurrence	Two-week course... Two-week course...	20 Years - 80 Years	Seoul St. Mary's Hospital
Two-week Course Versus Conventionally Fractionated Chemoradiotherapy in Rectal Cancer	NCT02484040	Response to Tox... Toxicity Recurrence	Two-week course... Two-week course...	20 Years - 80 Years	Seoul St. Mary's Hospital

Spots Global Cancer Trial Database for chemoradiotherpy