Simultaneous Boost in Neoadjuvant Radiotherapy for Rectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 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.
- Who it may be relevant to
- Registry conditions: Locally Advanced Rectal Adenocarcinoma. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Simultaneous Boost in Neoadjuvant Radiotherapy for Rectal Cancer：A Phase 2, Randomized Controlled Study
Overview
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.
Interventions
- Radiation GTV 58.75 Gy/25 fractions(Simultaneous Integrated Boost)
Patients will receive neoadjuvant long course radiotherapy using VMAT or IMAT with daily image guided. Gross tumor volume (GTV): A total dose of 58.75Gy delivered in 25 fractions using a simultaneous integrated boost approach; CTV: 45Gy/25f; Mesorectum lymph node(GTVnd1):58.75Gy/25f ; Lateral lymph node（GTVnd2）：60Gy/25f; - Radiation GTV 50 Gy/25 fractions(Simultaneous Integrated Boost)
Patients will receive neoadjuvant radiotherapy with GTV 50 Gy in 25 fractions , delivered with IMRT or VMAT technique. CTV: 45Gy/25f; Mesorectum lymph node(GTVnd1):58.75Gy/25f; Lateral lymph node（GTVnd2） - Drug Concurrent Chemotherapy
Concurrent administration of capecitabine (825 mg/m² twice daily, 5 days per week) or XELOX regimen during radiotherapy. - Procedure Total mesorectal excision (TME) surgery or non-operative management
After treatment, patients will undergo restaging and proceed to total mesorectal excision (TME) or non-operative management ("watch-and-wait") depending on response and clinical assessment.
Primary outcome measures
- CR [Time frame: 1 year]
Secondary outcome measures (5)
- 3-year disease free suvival rate [Time frame: 3 years]
- 3-year local control rate [Time frame: 3 years]
- Tumor Regression Grade [Time frame: 1 year]
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Time frame: 3 years]
- Organ Preservation Rate [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07200141 · I-25PJ2066