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| ID | Type | Description | Link |
|---|---|---|---|
| KCT0000525 | Registry Identifier | Clinical Research Information Service | |
| K-1208-001-002 | Other Identifier | Korea Institute of Radiological and Medical Sciences IRB |
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| Name | Class |
|---|---|
| Kyung Hee University Hospital at Gangdong | OTHER |
| Gachon University Gil Medical Center | OTHER |
| Catholic University of Korea, Yeouido St. Mary's Hospital | UNKNOWN |
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Radical treatment of primary rectal cancer with synchronous distant metastases includes surgical resection of primary and metastatic lesion. However, primary rectal cancer in case of metastasized disease are often locally advanced disease and need downsizing before surgery. It is reported that pelvic recurrence rates and distant metastasis rates outside liver are 30~35% and 60%, respectively. Therefore, combined treatment with radiotherapy and chemotherapy is used. However, the sequence of treatment modalities is not yet definitely established and preoperative chemoradiotherapy and surgical resection is accepted as an option of treatment. Conventional long course chemoradiotherapy delays administration of full-dose chemotherapy, and metastatic lesion can be progressed during chemoradiotherapy. In present study, we evaluate the efficacy of short course radiotherapy (SCRT) followed by full-dose chemotherapy with delayed surgical resection of the primary tumor and metastases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCRT/ChemoTx with Delayed Surgery | Experimental | Short course radiotherapy (25 Gy in 5 fractions) followed by intensive chemotherapy, compromising of FOLFOX of FOLFIRI (+-Bevacizumab or Cetuximab), with delayed surgery for rectal cancer with synchronous distant metastasis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short Course Radiotherapy | Radiation | Radiotherapy to tumor and draining lymph node with 25 Gy in 5 fractions within 5 working days |
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| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | R0 resection rate of primary and metastatic lesions | Expected average of 12 weeks (after resection) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival rate | From the first date of radiotherapy to the date of death or last follow-up | 2 years |
| Progression free survival rate | From the first date of radiotherapy to the date of first failure or last follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sun Mi Moon, MD, PhD | Contact | 82-2-970-1237 | msm386@yahoo.co.kr | |
| Won Il Jang, MD, MS | Contact | 82-2-970-1262 | zzang11@kirams.re.kr |
| Name | Affiliation | Role |
|---|---|---|
| Sun Mi Moon, MD, PhD | Korea Cancer Center Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Hee University Gangdong Hospital | Active, not recruiting | Seoul | 134-727 | South Korea | ||
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| Pusan National University Yangsan Hospital |
| OTHER |
| Gangnam Severance Hospital | OTHER |
| Severance Hospital | OTHER |
| Wonju Severance Christian Hospital | OTHER |
| Chungnam National University Hospital | OTHER |
| Dongtan Sacred Heart Hospital | OTHER |
| The Koreran Society of Coloproctology | UNKNOWN |
| The Catholic University of Korea | OTHER |
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|
| Chemotherapy | Drug |
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|
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| Delayed Surgery | Procedure | If primary tumor and metastases is resectable after FOLFOX or FOLFIRI (+-Bevacizumab or Cetuximab) of 3 cycles, patients have surgical resection (and/or radiofrequency ablation to metastases). |
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| 2 years |
| Tumor regression grade | Tumor regression grade of primary lesion | Just after resection & pathologic report |
| Toxicity | Adverse events using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 | 1 year |
| Korea Cancer Center Hospital |
| Recruiting |
| Seoul |
| 139-706 |
| South Korea |
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| 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 |
|---|---|
| D004358 | Drug Therapy |
| C410216 | Folfox protocol |
| D000068258 | Bevacizumab |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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