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Simultaneous Boost in Neoadjuvant Radiotherapy for Rectal Cancer

Study acronym: SIB-NCRT
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Interventions: Concurrent Chemotherapy (Drug), GTV 50 Gy/25 fractions(Simultaneous Integrated Boost) (Radiation), GTV 58.75 Gy/25 fractions(Simultaneous… to Concurrent Chemotherapy (Drug), GTV 50 Gy/25 fractions(Simultaneous Integrated Boost) (Radiation), GTV 58.75 Gy/25 fractions(Simultaneous… · Eligibility criteria expanded, about 17 words · Study description expanded, about 308 words Show 3 more changesShow less
    • Interventions: Concurrent Chemotherapy (Drug), GTV 50 Gy/25 fractions(Simultaneous Integrated Boost) (Radiation), GTV 58.75 Gy/25 fractions(Simultaneous… to Concurrent Chemotherapy (Drug), GTV 50 Gy/25 fractions(Simultaneous Integrated Boost) (Radiation), GTV 58.75 Gy/25 fractions(Simultaneous…
    • Eligibility criteria expanded, about 17 words
    • Study description expanded, about 308 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07200141
Lead Sponsor Peking Union Medical College Hospital
Conditions Locally Advanced Rectal Adenocarcinoma
Enrollment 156 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov