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| Name | Class |
|---|---|
| National Cancer Center, Korea | OTHER_GOV |
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The treatment protocol proposed in this study is to perform short-term radiation therapy and 4 cycles of FOLFOX chemotherapy for neoadjuvant treatment of locally advanced rectal cancer. Compared to conventional chemoradiation therapy, the preoperative radiotherapy period is shortened, and the cure rate of rectal cancer patients can be improved by early treatment of micrometastasis using systemic chemotherapy. The patients who are assigned to the study group will received the short-course radiotherapy and 4 cycles of FOLFOX and patients in the control will received conventional chemoradiotherapy for preoperative treatment. All patients are recommended to receive total mesorectal excision (TME) after neoadjuvant treatment and adjuvant chemotherapy will be given according to the pathological stage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | Short-course radiotherapy and 4 cycles of mFOLFOX6 followed by TME. Adjuvant chemotherapy will be given according to the pathological stage (CR~pStageI: 6 cycles of capecitabine or 4 cycles of 5-FU with leucovorin, pStageII-III: 8 cycles of mFOLFOX6) |
|
| Control group | Active Comparator | Conventional chemoradiotherapy followed by TME. Adjuvant chemotherapy will be given according to the pathological stage (CR~pStageI: 6 cycles of capecitabine or 4 cycles of 5-FU with leucovorin, pStageII-III: 8 cycles of mFOLFOX6) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| short-course radiotherapy | Radiation | 25 Gy in 5 fractions for 5 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year disease-free survival | To compare the 3-year disease-free survival between the experimental arm and the control arm | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| pCR rate | CR (complete regression), no tumor cells and only fibrotic mass or acellular mucin pools | within 30 days after TME |
| Toxicity of neoadjuvant radiotherapy and chemotherapy | Neoadjuvant treatment associated toxicity (Common Terminology Criteria for Adverse Events version v5.0) |
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Inclusion Criteria:
Exclusion Criteria: (one of the following criteria)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gyu seog Choi | Daegu | 702-210 | South Korea | |||
| Chungnam National University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37923987 | Derived | Kang MK, Park SY, Park JS, Kim HJ, Kim JG, Kang BW, Baek JH, Cho SH, Seo AN, Kim DW, Kim J, Baek SJ, Kim JH, Kim JY, Ha GW, Park EJ, Park IJ, Kim CH, Kang H, Choi GS. Preoperative sequential short-course radiation therapy and FOLFOX chemotherapy versus long-course chemoradiotherapy for locally advanced rectal cancer: a multicenter, randomized controlled trial (SOLAR trial). BMC Cancer. 2023 Nov 3;23(1):1059. doi: 10.1186/s12885-023-11363-7. |
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| mFOLFOX6 |
| Drug |
Oxaliplatin 85 mg/m2, Levoleucovorin 200mg (or Leucovroin, Leucosodium 400mg)/m2, 5- FU 400 mg/m2, and continuous 5- FU 2,400 mg/m2 for 46 hours |
|
| Chemoradiotherapy | Radiation | 45~50.4 Gy/25fr with concurrent use of either capecitabine or 5-FU+leucovorin(or levoleucovorin or leucosodium) |
|
| TME surgery | Procedure | TME surgery |
|
| 6 months |
| R0 resection | Rate of R0 resection of TME | within 30 days after TME |
| TRG | Pathological tumor regression grade (TRG) (Dworak/Mandard/AJCC TRG classification) | within 30 days after TME |
| Surgical complications | Surgical complications classified according to the Clavien-Dindo classification | within 60 days after TME |
| Incidence of peripheral neuropathy | Incidence of oxaliplatin-induced peripheral neuopathy | 3 years |
| European Organization for Research and Treatment of Cancer Quality of Life C30 | The EORTC Core Questionnaire (QLQ-C30) includes six clearly distinguishable functioning scales that have been thoroughly tested and validated on an international level and that are available in 110 different language versions | 2 year after surgery |
| European Organization for Research and Treatment of Cancer Quality of Life CR29 | The QLQ-CR29 has five functional and 18 symptom scales. It contains four subscales (urinary frequency (UF), blood and mucus in stool (BMS), stool frequency (SF), and body image (BI)) and 19 single items (urinary incontinence, dysuria, abdominal pain, buttock pain, bloating, dry mouth, hair loss, taste, anxiety, weight, flatulence, fecal incontinence, sore skin, embarrassment, stoma care problems, sexual interest (men), impotence, sexual interest (women), and dyspareunia) [11]. Patients are asked to indicate their symptoms during the past week(s). Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales. | 2 year after surgery |
| Low Anterior Resection Syndrome score | Low anterior resection syndrome (LARS) score ; 0 to 20 (no LARS), 21 to 29 (minor LARS ) and 30 to 42 (Major LARS ) | 2 year after surgery |
| The International Index of Erectile Function-5 score, retrograde ejaculation | Quality of life IIEF-5, retrograde ejaculation | 2 year after surgery |
| 5-year disease-free survival | To compare the 5-year disease-free survival between the experimental arm and the control arm | 5 years |
| 3-year overall survival | To compare the 3-year overall survival between the experimental arm and the control arm | 3 years |
| 5-year overall survival | To compare the 5-year overall survival between the experimental arm and the control arm | 5 years |
| Loco-regional recurrence | To compare the 3 year and 5-year loco-regional recurrence between the experimental arm and the control arm | 5 years |
| Distant metastasis | To compare the 3 year and 5-year distant metastasis between the experimental arm and the control arm | 5 years |
| Daejeon |
| South Korea |
| Chonnam National University Hwasun Hospital | Gwangju | South Korea |
| Catholic University of Korea Incheon St. Mary's Hospital | Incheon | South Korea |
| Jeonbuk National University Hospital | Jeonju | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| , Korea University Anam Hospital | Seoul | South Korea |
| Gangnam Severance Hospital | Seoul | South Korea |
| Seoul National University Bundang Hospital | Seoul | South Korea |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| 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 |
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| ID | Term |
|---|---|
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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