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Simultaneous Boost in Neoadjuvant Radiotherapy for Rectal Cancer

NCT ID: NCT07200141

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2028-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Locally Advanced Rectal Adenocarcinoma

Keywords

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locally advanced rectal cancer Neoadjuvant Chemoradiotherapy Dose Escalation Simultaneous Integrated Boost

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental Arm (GTV 58.75 Gy/25f)

Radiotherapy: long course simultaneous integrated boost radiotherapy

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

Group Type EXPERIMENTAL

GTV 58.75 Gy/25 fractions(Simultaneous Integrated Boost)

Intervention Type 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;

Concurrent Chemotherapy

Intervention Type 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

Intervention Type PROCEDURE

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.

Control Arm (PGTV 50 Gy/25f)

Radiotherapy: long course simultaneous integrated boost radiotherapy Gross tumor volume (GTV): A total dose of 50Gy 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 Concurrent Chemotherapy: Concurrent administration of capecitabine (825 mg/m² twice daily, 5 days per week) or XELOX regimen during radiotherapy 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.

Group Type ACTIVE_COMPARATOR

GTV 50 Gy/25 fractions(Simultaneous Integrated Boost)

Intervention Type 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

Intervention Type 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

Intervention Type PROCEDURE

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.

Interventions

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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;

Intervention Type 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）

Intervention Type RADIATION

Concurrent Chemotherapy

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

Intervention Type DRUG

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18 and \<80 years
2. Histologically confirmed rectal adenocarcinoma
3. Tumor located within 10 cm from the anal verge
4. MRI staging: T3-T4 and/or N+, M0 (AJCC 8th edition)
5. ECOG performance status 0-2
6. Adequate bone marrow function: WBC ≥3×10⁹/L, ANC ≥1.5×10⁹/L, PLT ≥100×10⁹/L, Hb ≥90 g/L
7. Adequate liver function: TBIL ≤1.5 × ULN, ALT/AST ≤2.5 × ULN
8. Adequate renal function: Cr ≤1.5 × ULN or CCr ≥60 mL/min
9. Signed informed consent

Exclusion Criteria

1. Prior rectal cancer surgery
2. Prior induction chemotherapy, immunotherapy, or pelvic radiotherapy
3. History of other malignancies
4. History of chronic colitis, ulcerative colitis, or nonspecific proctitis
5. Pregnant or breastfeeding women
6. Active infection or fever
7. Severe uncontrolled comorbidities (e.g., unstable heart disease, renal disease, chronic hepatitis, uncontrolled diabetes, psychiatric disorders)
8. Inability to comply with study protocol
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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I-25PJ2066

Identifier Type: -

Identifier Source: org_study_id