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| Name | Class |
|---|---|
| Korean Cancer Study Group | OTHER |
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The current standard treatment of locally advanced rectal cancer (clinical stage II or III) is preoperative radiation with chemotherapy (CRT) followed by surgery. But this approach can be suboptimal for patients with high risk features (more deeply-seated tumor or many regional lymph nodes involved)that are associated with recurrence. This study test a hypothesis that CRT followed by chemotherapy before surgery can improve efficacy of preoperative treatment.
Downstaging rate with CRT using fluoropyrimidine monotherapy is usually 30-40%.In MRI-defined high-risk patients, downstaging rate with conventional fluoropyrimidine-based monotherapy with radiation has not been shown. We assume that the downstaging rate of chemoradiation arm (control arm) would be 30%, and that addition of CapOx after CRT (experimental arm) may increase downstaging rate 30% to 50%. A sample size of 52 patients per group is needed have 85% power to detect downstaging rate = 50% as compared to 30% with type I error rate of 15%. We will perform one interim futility analysis when half of the patients are recruited and evaluated for the primary endpoint. O'Brien-Fleming boundary will be considered. Therefore, when 26 patients per arm are evaluated, the interim futility analysis will be performed, and when the Z score at the interim is less than -0.09192 (one-sided p-value greater than 0.5366192), the study will be stopped for futility. Considering 5% follow-up loss, a sample size of 55 per arm (a total of 110 patients) will be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chemoradiation followed by CapOx | Experimental | preoperative chemoradiation 50.4Gy with capecitabine or 5-fluorouracil/leucovorin (pelvic radiation capecitabine 5-fluorouracil) followed by 2 cycles of chemotherapy (Capecitabine Oxaliplatin - CapOx) and surgery (total mesorectal excision) |
|
| chemoradiation | Active Comparator | preoperative chemoradiation 50.4Gy with capecitabine or 5-fluorouracil/leucovorin (pelvic radiation capecitabine 5-fluorouracil) followed by rest for 8 weeks and surgery (total mesorectal excision) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine Oxaliplatin | Drug | after completion of chemoradiation, two cycles of capecitabine (850mg/m2 twice daily from D1 evening to D15 morning) and oxaliplatin (100mg/m2 on D1) will be administered every 3 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| downstaging rate | downstaging rate is defined as the proportion of patients with ypStage (pathologic stage after preoperative treatment) 0 or I (from pathologic findings after preoperative treatment and surgery) out of all patients who were assigned to each arm. | expected average of 15 weeks after start of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| pathologic response | pathologic response is assessed by Dworak's grading system from postoperative specimen. | expected average of 15 weeks after start of study treatment |
| radiologic response rate |
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Inclusion Criteria:
histologically confirmed adenocarcinoma of the rectum
distal margin of tumor located from 0 to 12 cm from anal verge measured by digital rectal examination
high risk clinical stage II or III in MRI (satisfying at least one of the followings)
age 20 years or more
ECOG (Eastern Cooperative Oncology Group) performance status 0-2
No prior chemotherapy, radiotherapy to pelvis
Adequate bone marrow function
Adequate renal function
Adequate hepatic function
patients must sign the informed consent indicating that they were aware of the investigational nature of the study in keeping with the policy of the hospital
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sun Young Kim, MD | Asan Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Goyang-si | Gyeonggi-do | 410-769 | South Korea | ||
| Seoul National University Bundang Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29976501 | Derived | Kim SY, Joo J, Kim TW, Hong YS, Kim JE, Hwang IG, Kim BG, Lee KW, Kim JW, Oh HS, Ahn JB, Zang DY, Kim DY, Oh JH, Baek JY. A Randomized Phase 2 Trial of Consolidation Chemotherapy After Preoperative Chemoradiation Therapy Versus Chemoradiation Therapy Alone for Locally Advanced Rectal Cancer: KCSG CO 14-03. Int J Radiat Oncol Biol Phys. 2018 Jul 15;101(4):889-899. doi: 10.1016/j.ijrobp.2018.04.013. Epub 2018 Apr 12. |
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|
| pelvic radiation capecitabine 5-fluorouracil | Radiation | 50.4Gy of pelvic radiation with capecitabine or 5-fluorouracil |
|
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radiologic response will be assessed according to RECIST (Response Evaluation Criteria in Solid Tumors) guideline 1.1
| expected average of 14 weeks after start of study treatment |
| toxicity profile | Toxicities or any adverse events during study treatment, surgery and follow-up period will be assessed according to NCI CTCAE (Common Terminology Criteria for Adverse Events) version 4.0 | expected average of 35 weeks after start of study treatment |
| pattern of failure | if any recurrent lesion is noticed, anatomic sites of recurrent lesions and the date and the name of exam or imaging study (physical exam, CT or MRI…) will be recorded in case report form. | 3 years after surgery |
| local control rate | Local recurrence is defined as tumor recurrence confined in radiation field (pelvic cavity). Cumulative incidence of local recurrence will be suggested. | 3 years after surgery |
| relapse-free survival | Time from date of operation to date of recurrence of disease or deaths due to recurrence or progression of disease. | 3 years after surgery |
| Disease-free survival | time from date of operation to date of recurrence of disease, a new occurrence of secondary colorectal cancer, a new occurrence of other malignancy, or deaths from any cause. | 3 years after surgery |
| overall survival | time from date of operation to date of death due to any cause. | 3 years after surgery |
| quality of life | quality of life will be measured with FACT-C | before study treatment, 7 weeks after completion of chemoradiation, and at 4 weeks after surgery |
| Seongnam-si |
| Gyeonggi-do |
| 13620 |
| South Korea |
| Hallym University Sacred Heart Hospital | Anyang | South Korea |
| Gangneung Asan Hospital | Gangneung | South Korea |
| Severance Hospital | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Chung-Ang University Hospital | Seoul | 06973 | South Korea |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C519688 | XELOX |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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