Recurrence, Response to Toxin, Toxicity
Conditions
Keywords
tumor response, toxicity, recurrence, chemoradiotherpy, rectum
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
Interventions
RADIATIONTwo-week course of radiation
33 Gy in 10 fractions for 2 weeks
Sponsors
Jong Hoon Lee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor response from stage II-III to stage 0-I | from clinical staging time to radical surgery date (about 3 months) | Downstaging rate was evaluated by comparing pre-clinical and post-CRT pathological stages, and downstaging was defined as ypStage 0-I (ypT0-2N0M0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity (acute and chronic) | from radiation start to 3 years after radical surgery | 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 | 3-year recurrence-free survival and 3-year overall survival | — |
Countries
South Korea
Contacts
Primary ContactJong Hoon Lee, MD
Outcome results
None listed