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The goal of this clinical trial is to learn whether new adjuvant radiotherapy with gross tumor volume(GTV) escalated to 58.75 Gy can improve complete response (CR) rates compared with GTV dose of 50 Gy in adult patients (18-79 years) with locally advanced rectal adenocarcinoma (T3-T4/N+, M0) located ≤10 cm from the anal verge.The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm (GTV 58.75 Gy/25f) | Experimental | Radiotherapy: long course simultaneous integrated boost radiotherapy
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| Control Arm (PGTV 50 Gy/25f) | Active Comparator | Radiotherapy: long course simultaneous integrated boost radiotherapy Gross tumor volume (GTV): A total dose of 50Gy delivered in 25 fractions using a simultaneous integrated boost approach. CTV: 45Gy/25f Mesorectum lymph node(GTVnd1):58.75Gy/25f Lateral lymph node(GTVnd2):60Gy/25f Concurrent Chemotherapy: Concurrent administration of capecitabine (825 mg/m² twice daily, 5 days per week) or XELOX regimen during radiotherapy After treatment, patients will undergo restaging and proceed to total mesorectal excision (TME) or non-operative management ("watch-and-wait") depending on response and clinical assessment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GTV 58.75 Gy/25 fractions(Simultaneous Integrated Boost) | Radiation | Patients will receive neoadjuvant long course radiotherapy using VMAT or IMAT with daily image guided. Gross tumor volume (GTV): A total dose of 58.75Gy delivered in 25 fractions using a simultaneous integrated boost approach; CTV: 45Gy/25f; Mesorectum lymph node(GTVnd1):58.75Gy/25f ; Lateral lymph node(GTVnd2):60Gy/25f; |
| Measure | Description | Time Frame |
|---|---|---|
| CR | primary tumor achieved pathological complete response or clinical complete response. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year disease free suvival rate | The proportion of patients from the initiation of surgery to tumor recurrence or death within 3 years | 3 years |
| 3-year local control rate | The proportion of patients absence of pelvic tumor progression, including primary tumor regrowth or regional lymph node progression, within 3 years after randomization. |
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Inclusion Criteria:
Exclusion Criteria:
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| GTV 50 Gy/25 fractions(Simultaneous Integrated Boost) | Radiation | Patients will receive neoadjuvant radiotherapy with GTV 50 Gy in 25 fractions , delivered with IMRT or VMAT technique. CTV: 45Gy/25f; Mesorectum lymph node(GTVnd1):58.75Gy/25f; Lateral lymph node(GTVnd2) |
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| Concurrent Chemotherapy | Drug | Concurrent administration of capecitabine (825 mg/m² twice daily, 5 days per week) or XELOX regimen during radiotherapy. |
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| Total mesorectal excision (TME) surgery or non-operative management | Procedure | After treatment, patients will undergo restaging and proceed to total mesorectal excision (TME) or non-operative management ("watch-and-wait") depending on response and clinical assessment. |
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| 3 years |
| Tumor Regression Grade | Pathological tumor regression grade (TRG) according to CAP criteria. | 1 year |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Acute and late adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | 3 years |
| Organ Preservation Rate | The proportion of patients who retain anal sphincter function without permanent stoma, including watch-and-wait, Dixon procedure or sphincter-preserving resection. | 1 year |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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