Status:
NOT_YET_RECRUITING
Simultaneous Boost in Neoadjuvant Radiotherapy for Rectal Cancer
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Locally Advanced Rectal Adenocarcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 G...
Eligibility Criteria
Inclusion
- Age ≥18 and \<80 years
- Histologically confirmed rectal adenocarcinoma
- Tumor located within 10 cm from the anal verge
- MRI staging: T3-T4 and/or N+, M0 (AJCC 8th edition)
- ECOG performance status 0-2
- Adequate bone marrow function: WBC ≥3×10⁹/L, ANC ≥1.5×10⁹/L, PLT ≥100×10⁹/L, Hb ≥90 g/L
- Adequate liver function: TBIL ≤1.5 × ULN, ALT/AST ≤2.5 × ULN
- Adequate renal function: Cr ≤1.5 × ULN or CCr ≥60 mL/min
- Signed informed consent
Exclusion
- Prior rectal cancer surgery
- Prior induction chemotherapy, immunotherapy, or pelvic radiotherapy
- History of other malignancies
- History of chronic colitis, ulcerative colitis, or nonspecific proctitis
- Pregnant or breastfeeding women
- Active infection or fever
- Severe uncontrolled comorbidities (e.g., unstable heart disease, renal disease, chronic hepatitis, uncontrolled diabetes, psychiatric disorders)
- Inability to comply with study protocol
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT07200141
Start Date
October 1 2025
End Date
December 1 2028
Last Update
September 30 2025
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