Simultaneous Boost in Neoadjuvant Radiotherapy for Rectal Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking Union Medical College Hospital

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

156 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Peking Union Medical College Hospital

Lead sponsor