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โ† Trials
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Simultaneous Boost in Neoadjuvant Radiotherapy for Rectal Cancer

RecruitingPhase 2Ages 18 Years - 80 YearsAllPeking Union Medical College Hospital
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In plain words

What the trial is, and whether it could suit you

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 โ‰ค10 cm from the anal verge.The main questions it aims to answer are: 1. Does GTV simultaneously boost to 58.75 Gy/25f increase complete response (pCR or cCR) compared with 50 Gy/25f? 2. How do the two regimens differ in terms of progression-free survival (PFS), pelvic local control (LC), tumor regression grade (TRG), organ preservation, and treatment-related toxicity? Researchers will compare GTV 58.75 Gy/25f (experimental arm) versus GTV 50 Gy/25f (control arm) to see if dose escalation improves tumor response rate. Participants will: 1. Receive neoadjuvant radiotherapy with one of the tw

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age โ‰ฅ18 and \<80 years 2. Histologically confirmed rectal adenocarcinoma 3. Tumor located within 10 cm from the anal verge 4. MRI staging: T3-T4 and/or N+, M0 (AJCC 8th edition) 5. ECOG performance status 0-2 6. Adequate bone marrow function: WBC โ‰ฅ3ร—10โน/L, ANC โ‰ฅ1.5ร—10โน/L, PLT โ‰ฅ100ร—10โน/L, Hb โ‰ฅ90 g/L 7. Adequate liver function: TBIL โ‰ค1.5 ร— ULN, ALT/AST โ‰ค2.5 ร— ULN 8. Adequate renal function: Cr โ‰ค1.5 ร— ULN or CCr โ‰ฅ60 mL/min 9. Signed informed consent Exclusion Criteria: 1. Prior rectal cancer surgery 2. Prior induction chemotherapy, immunotherapy, or pelvic radiotherapy 3. History of other malignancies 4. History of chronic colitis, ulcerative colitis, or nonspecific proctitis 5. Pregnant or breastfeeding women 6. Active infection or fever 7. Severe uncontrolled comorbidities (e.g., unstable heart disease, renal disease, chronic hepatitis, uncontrolled diabetes, psychiatric disorders) 8. Inability to comply with study protocol
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What it tests

  • GTV 58.75 Gy/25 fractions(Simultaneous Integrated Boost)
  • GTV 50 Gy/25 fractions(Simultaneous Integrated Boost)
  • Concurrent Chemotherapy
  • Total mesorectal excision (TME) surgery or non-operative management
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Where

1 site
Peking Union Medical College Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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