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Simultaneous Boost in Neoadjuvant Radiotherapy for Rectal Cancer

ConditionLocally Advanced Rectal Adenocarcinoma
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • GTV 58.75 Gy/25 fractions(Simultaneous Integrated Boost)

    Radiation

    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;

  • GTV 50 Gy/25 fractions(Simultaneous Integrated Boost)

    Radiation

    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）

  • Concurrent Chemotherapy

    Drug

    Concurrent administration of capecitabine (825 mg/m² twice daily, 5 days per week) or XELOX regimen during radiotherapy.

  • Total mesorectal excision (TME) surgery or non-operative management

    Procedure/Surgery

    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.

Treatment groups

156 Participants
are divided into 2 treatment groups
Group A: Experimental Arm (GTV 58.75 Gy/25f)Experimental treatment 3 interventions
Group B: Control Arm (PGTV 50 Gy/25f)Active comparator 3 interventions

Trial outcomes

Primary outcomes

1

CR

primary tumor achieved pathological complete response or clinical complete response.

Time frame
1 year

Secondary outcomes

1

3-year disease free suvival rate

The proportion of patients from the initiation of surgery to tumor recurrence or death within 3 years

Time frame
3 years
2

3-year local control rate

The proportion of patients absence of pelvic tumor progression, including primary tumor regrowth or regional lymph node progression, within 3 years after randomization.

Time frame
3 years
3

Tumor Regression Grade

Pathological tumor regression grade (TRG) according to CAP criteria.

Time frame
1 year
4

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Acute and late adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking Union Medical College Hospital

Lead sponsor

Source ClinicalTrials.gov
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