About this trial
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:
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 two PGTV dose escalated regimens (with concurrent chemotherapy: oral capecitabine or XELOX). 2. Undergo restaging with imaging and clinical assessment before surgery or observation. 3. Proceed to total mesorectal excision (TME), local excision, or "watch-and-wait" strategy depending on treatment response and patient preference. 4. Be followed regularly with clinical exams, imaging, endoscopy, and laboratory tests to assess efficacy, safety, and long-term outcomes.
Eligibility criteria
Qualifiers
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)
Disqualifiers
Prior rectal cancer surgery
Prior induction chemotherapy, immunotherapy, or pelvic radiotherapy
History of other malignancies
History of chronic colitis, ulcerative colitis, or nonspecific proctitis
Trial design
Treatments tested in this trial
- 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
Treatment groups
Locations
Sponsors and collaborators
Peking Union Medical College Hospital
Lead sponsor