Locally Advanced Rectal AdenocarcinomaPhase 2SIB-NCRTNCT07200141
Simultaneous Boost in Neoadjuvant Radiotherapy for Rectal Cancer
A Phase 2 study testing GTV 58.75 Gy/25 fractions(Simultaneous Integrated Boost), GTV 50 Gy/25 fractions(Simultaneous Integrated Boost) and Concurrent Chemotherapy in people with Locally Advanced Rectal Adenocarcinoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Locally Advanced Rectal Adenocarcinoma
- What is being tested?
- GTV 58.75 Gy/25 fractions(Simultaneous Integrated Boost), GTV 50 Gy/25 fractions(Simultaneous Integrated Boost) and Concurrent Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 1 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
ke hu, huke8000@126.com
About this study
Official title: Simultaneous Boost in Neoadjuvant Radiotherapy for Rectal Cancer：A Phase 2, Randomized Controlled Study
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:
- Does GTV simultaneously boost to 58.75 Gy/25f increase complete response (pCR or cCR) compared with 50 Gy/25f?
- 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.
Read more
Participants will:
- Receive neoadjuvant radiotherapy with one of the two PGTV dose escalated regimens (with concurrent chemotherapy: oral capecitabine or XELOX).
- Undergo restaging with imaging and clinical assessment before surgery or observation.
- Proceed to total mesorectal excision (TME), local excision, or "watch-and-wait" strategy depending on treatment response and patient preference.
- Be followed regularly with clinical exams, imaging, endoscopy, and laboratory tests to assess efficacy, safety, and long-term outcomes.
Read the detailed description
This study is a randomized controlled trial designed to evaluate the clinical efficacy and safety of simultaneous integrated boost (SIB) dose escalation in the neoadjuvant treatment of locally advanced rectal cancer (LARC).Standard neoadjuvant chemoradiotherapy (nCRT) typically utilizes a dose of 50 Gy to the gross tumor volume (GTV). This trial investigates whether escalating the radiation dose specifically to the GTV to 58.75 Gy, delivered in 25 fractions, can significantly enhance tumor downstaging and increase the rates of pathologic complete response (pCR) or sustained clinical complete response (cCR).Study Arms and Radiation Technique:Participants are randomized into two arms. Both arms receive intensity-modulated radiation therapy (IMRT) or volumetric-modulated arc therapy (VMAT) with concurrent fluoropyrimidine-based chemotherapy.Experimental Arm: The planned target volume of the GTV (PGTV) receives a total dose of 58.75 Gy in 25 fractions ($2.35 \text{ Gy/fraction}$), while the elective lymphatic drainage areas (PTV) receive 45-50 Gy.Control Arm: The PGTV receives a total dose of 50 Gy in 25 fractions ($2.0 \text{ Gy/fraction}$), consistent with standard-of-care protocols.Clinical Workflow:Following the completion of neoadjuvant therapy, patients will undergo a mandatory restaging assessment 6-12 weeks post-radiation. This evaluation includes digital rectal examination (DRE), pelvic multiparametric MRI (mpMRI), and endoscopy.Surgical Intervention and Organ Preservation:Patients achieving a cCR may be offered a "Watch-and-Wait" (W\&W) strategy with intensive surveillance, aiming for organ preservation.Patients with a good but incomplete response may undergo local excision (LE) or total mesorectal excision (TME).The primary endpoint is the combined complete response (CR) rate, defined as pCR for those undergoing surgery and cCR (sustained for at least 6 months) for those entering the W\&W protocol.Secondary Objectives:The study will also perform a comparative analysis of progression-free survival (PFS), local control (LC) rates, and the distribution of Tumor Regression Grade (TRG). Safety profiles will be rigorously monitored using the Common Terminology Criteria for Adverse Events (CTCAE), focusing on acute and late gastrointestinal and genitourinary toxicities.
- Conditions
- Locally Advanced Rectal Adenocarcinoma
- Being tested
- 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
- Keywords
- locally advanced rectal cancer, Neoadjuvant Chemoradiotherapy, Dose Escalation, Simultaneous Integrated Boost
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 ChemotherapyDrug
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 managementProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm (GTV 58.75 Gy/25f) | Experimental | 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. Receives: Radiation: GTV 58.75 Gy/25 fractions(Simultaneous Integrated Boost); Drug: Concurrent Chemotherapy; Procedure: Total mesorectal excision (TME) surgery or non-operative management |
| Control Arm (PGTV 50 Gy/25f) | Active comparator | 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. Receives: Radiation: GTV 50 Gy/25 fractions(Simultaneous Integrated Boost); Drug: Concurrent Chemotherapy; Procedure: Total mesorectal excision (TME) surgery or non-operative management |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR
primary tumor achieved pathological complete response or clinical complete response.
Measured: 1 year
Secondary outcomes (5)
3-year disease free suvival rate
The proportion of patients from the initiation of surgery to tumor recurrence or death within 3 years
Measured: 3 years
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.
Measured: 3 years
Tumor Regression Grade
Pathological tumor regression grade (TRG) according to CAP criteria.
Measured: 1 year
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.
Measured: 3 years
Organ Preservation Rate
The proportion of patients who retain anal sphincter function without permanent stoma, including watch-and-wait, Dixon procedure or sphincter-preserving resection.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start1 Oct 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200141
- Sponsor's protocol ID
- I-25PJ2066
- Acronym
- SIB-NCRT
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Boost in Neoadjuvant Radiotherapy for Rectal Cancer：A Phase 2, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07200141
- Acronym / sponsor ID
- SIB-NCRT / I-25PJ2066
- Conditions
- Locally Advanced Rectal Adenocarcinoma
- Keywords
- locally advanced rectal cancer, Neoadjuvant Chemoradiotherapy, Dose Escalation, Simultaneous Integrated Boost
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does GTV simultaneously boost to 58.75 Gy/25f increase complete response (pCR or cCR) compared with 50 Gy/25f?
- 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:
- Receive neoadjuvant radiotherapy with one of the two PGTV dose escalated regimens (with concurrent chemotherapy: oral capecitabine or XELOX).
- Undergo restaging with imaging and clinical assessment before surgery or observation.
- Proceed to total mesorectal excision (TME), local excision, or "watch-and-wait" strategy depending on treatment response and patient preference.
- Be followed regularly with clinical exams, imaging, endoscopy, and laboratory tests to assess efficacy, safety, and long-term outcomes.
Detailed description
This study is a randomized controlled trial designed to evaluate the clinical efficacy and safety of simultaneous integrated boost (SIB) dose escalation in the neoadjuvant treatment of locally advanced rectal cancer (LARC).Standard neoadjuvant chemoradiotherapy (nCRT) typically utilizes a dose of 50 Gy to the gross tumor volume (GTV). This trial investigates whether escalating the radiation dose specifically to the GTV to 58.75 Gy, delivered in 25 fractions, can significantly enhance tumor downstaging and increase the rates of pathologic complete response (pCR) or sustained clinical complete response (cCR).Study Arms and Radiation Technique:Participants are randomized into two arms. Both arms receive intensity-modulated radiation therapy (IMRT) or volumetric-modulated arc therapy (VMAT) with concurrent fluoropyrimidine-based chemotherapy.Experimental Arm: The planned target volume of the GTV (PGTV) receives a total dose of 58.75 Gy in 25 fractions ($2.35 \text{ Gy/fraction}$), while the elective lymphatic drainage areas (PTV) receive 45-50 Gy.Control Arm: The PGTV receives a total dose of 50 Gy in 25 fractions ($2.0 \text{ Gy/fraction}$), consistent with standard-of-care protocols.Clinical Workflow:Following the completion of neoadjuvant therapy, patients will undergo a mandatory restaging assessment 6-12 weeks post-radiation. This evaluation includes digital rectal examination (DRE), pelvic multiparametric MRI (mpMRI), and endoscopy.Surgical Intervention and Organ Preservation:Patients achieving a cCR may be offered a "Watch-and-Wait" (W\&W) strategy with intensive surveillance, aiming for organ preservation.Patients with a good but incomplete response may undergo local excision (LE) or total mesorectal excision (TME).The primary endpoint is the combined complete response (CR) rate, defined as pCR for those undergoing surgery and cCR (sustained for at least 6 months) for those entering the W\&W protocol.Secondary Objectives:The study will also perform a comparative analysis of progression-free survival (PFS), local control (LC) rates, and the distribution of Tumor Regression Grade (TRG). Safety profiles will be rigorously monitored using the Common Terminology Criteria for Adverse Events (CTCAE), focusing on acute and late gastrointestinal and genitourinary toxicities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm (GTV 58.75 Gy/25f) | Experimental | Radiation: GTV 58.75 Gy/25 fractions(Simultaneous Integrated Boost), Drug: Concurrent Chemotherapy, Procedure: Total mesorectal excision (TME) surgery or non-operative managementRadiotherapy: 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. |
| Control Arm (PGTV 50 Gy/25f) | Active comparator | Radiation: GTV 50 Gy/25 fractions(Simultaneous Integrated Boost), Drug: Concurrent Chemotherapy, Procedure: Total mesorectal excision (TME) surgery or non-operative managementRadiotherapy: 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Experimental Arm (GTV 58.75 Gy/25f) |
| 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） | Radiation | Control Arm (PGTV 50 Gy/25f) |
| Concurrent ChemotherapyConcurrent administration of capecitabine (825 mg/m² twice daily, 5 days per week) or XELOX regimen during radiotherapy. | Drug | Control Arm (PGTV 50 Gy/25f), Experimental Arm (GTV 58.75 Gy/25f) |
| Total mesorectal excision (TME) surgery or non-operative managementAfter 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. | Procedure or surgery | Control Arm (PGTV 50 Gy/25f), Experimental Arm (GTV 58.75 Gy/25f) |
Primary outcome
CR
Time frame: 1 year
primary tumor achieved pathological complete response or clinical complete response.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GTV 58.75 Gy/25 fractions(Simultaneous Integrated Boost), GTV 50 Gy/25 fractions(Simultaneous Integrated Boost) and Concurrent Chemotherapy in people with Locally Advanced Rectal Adenocarcinoma, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ke hu (86-010-69155482, huke8000@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CR (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.