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The study is designed to analyze the pathological tumor response on locally advanced rectal cancer after preoperative treatment with neo-adjuvant therapy regimen or with chemotherapy combined with short-course radiotherapy in a prospective cohort and to correlate this response with patient's outcome
This is a phase II , open label, randomized study in patients with confirmed diagnosis of locally advanced rectal cancer. The study is designed to analyze the pathological tumor response on locally advanced rectal cancer after preoperative treatment with neo-adjuvant therapy regimen or with chemotherapy combined with short-course radiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative chemotherapy with short-course radiotherapy | Experimental | Preoperative treatment:4 course of FOLFOX4 therapy combined with short-course radiotherapy |
|
| Preoperative neo-adjuvant therapy | Active Comparator | Preoperative treatment:neo-adjuvant therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short-course radiotherapy | Radiation | Preoperative Radiation doses: 25 Gy in 5 fractions to the pelvis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Response | Treatment effects of interventions. The tumor response should be graded on a scale of 0 (complete response- no viable cancer cells observed) to 3 (poor response - minimal or no tumor kill; extensive residual cancer) | Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year Disease-Free Survival | time from radical resection to recurrence or end of follow-up | 3 years |
| 3-year Overall Survival | time from radical resection to cancer caused death or end of follow-up |
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Inclusion Criteria:
Exclusion Criteria:
12.Chronic inflammatory bowel disease, bowel obstruction,hereditary fructose intolerance 13.Medicine abuse;medical,psychologic or social conditions might disturb patients or results 14.Known or suspected allergy to any drugs in this study 15.Any situation or status that might endanger patient's safety or compliance 16.Pregnant woman or suckling period woman; Fertility without taking sufficient contraception 17.History of pelvic radiotherapy
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Long Cui, MD.PhD. | Contact | +86-25077850 | longcuidr@126.com |
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| FOLFOX4 chemotherapy,preoperative | Drug | FOLFOX4 chemotherapy:5-FU 400 mg/m2 i.v. bolus and Leucovorin 200 mg/m2 i.v. followed by 5-FU 600 mg/m2 i.v. 22 h-infusion day 1 + 2, oxaliplatin 85 mg/m2 day 1. Repeat every 2 weeks |
|
| Radiotherapy of neo-adjuvant therapy | Radiation | Preoperative Radiation doses: 45 Gy in 25 fractions to the pelvis, 5.4 Gy in 3 fractions to the pelvis |
|
| Concurrent chemotherapy of neo-adjuvant therapy | Drug | Capecitabine 825mg/m2 twice daily 5 days/week |
|
| Radical rectal cancer resection | Procedure | Radical rectal cancer resection |
|
| FOLFOX4 chemotherapy,post-operative | Drug | FOLFOX4 chemotherapy:5-FU 400 mg/m2 i.v. bolus and Leucovorin 200 mg/m2 i.v. followed by 5-FU 600 mg/m2 i.v. 22 h-infusion day 1 + 2, oxaliplatin 85 mg/m2 day 1. Repeat every 2 weeks |
|
| 3 year |
| 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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