Rectal CancerNCT07080411
the Efficacy of MR-guided Online Adaptive Radiotherapy for Locally Advanced Rectal Cancer
A study testing short course radiotherapy using MR-linac in people with Rectal Cancer and Adaptive Radiotherapy, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Trial summary
Based on preliminary findings on the motion error of the clinical target volume (CTV) in MR-guided adaptive radiotherapy (MRgART) for locally advanced rectal cancer (LARC), this study aims to reduce CTV-to-PTV margins and evaluate the complete response (CR) rate following MRgART in LARC patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer, Adaptive Radiotherapy
- What is being tested?
- short course radiotherapy using MR-linac
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 31 Dec 2029
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years, regardless of gender;
- Staged as II/III (cT3-T4N0 or cT2-4N+, no distant metastasis) by MRI or endoscopic ultrasound (according to the AJCC Cancer Staging Manual, 8th Edition);
- Fibrocolonoscopy or digital rectal examination confirms the lower border of the lesion is ≤10 cm from the anal verge;
- Pathologically confirmed or reviewed diagnosis of rectal adenocarcinoma;
- ECOG performance status of 0-1;
- Laboratory test results meeting the following criteria: Hemoglobin ≥ 90 g/L, white blood cells ≥ 3.5×10⁹/L; Neutrophils ≥ 1.5×10⁹/L, platelets ≥ 100×10⁹/L; Creatinine ≤ 1.0× upper normal limit (UNL), blood urea nitrogen (BUN) ≤ 1.0× UNL; Alanine aminotransferase (ALT) ≤ 1.5× UNL; Aspartate aminotransferase (AST) ≤ 1.5× UNL; Alkaline phosphatase (ALP) ≤ 1.5× UNL; Total bilirubin (TBIL) ≤ 1.5× UNL; Urine protein (-); normal bleeding and clotting time.
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- No history of allergy to 5-Fu drugs or platinum-based drugs;
- Primary rectal cancer patients must not have undergone surgery (except palliative colostomy), chemotherapy, or other antitumor treatments from diagnosis to enrollment;
- No prior radiation therapy to the intended treatment site;
- Signed informed consent form.
Who cannot join
- Presence of MRI-incompatible metal implants or claustrophobia;
- Previous treatment with anti-PD-1/L1, anti-CTLA-4 immunotherapy, or other experimental immunotherapeutic drugs;
- History of severe autoimmune diseases, including active inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (e.g., Wegener's granulomatosis), etc.;
- Symptomatic interstitial lung disease or active infectious/non-infectious pneumonia;
- Risk factors for intestinal perforation, such as active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal malignancies, or other known predisposing conditions;
- History of other malignancies, except for curable non-melanoma skin cancer or cervical carcinoma in situ;
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- Active infections, heart failure, myocardial infarction within the past 6 months, unstable angina, or unstable arrhythmia;
- Physical examination or clinical findings that, in the investigator's judgment, may interfere with results or increase the patient's risk of treatment complications, or other uncontrolled medical conditions;
- Women who are pregnant or breastfeeding;
- Congenital or acquired immunodeficiency disorders, including human immunodeficiency virus (HIV) infection, or history of organ transplantation or allogeneic stem cell transplantation.
- Active hepatitis B virus (HBV) infection (HBV-DNA ≥2000 U/mL), hepatitis C virus (HCV) infection, or active tuberculosis infection;
- Prior administration of a cancer vaccine or receipt of any other vaccine within 4 weeks before treatment initiation.
- (Note: Inactivated vaccines, such as seasonal flu shots, are permitted, whereas live attenuated vaccines, such as intranasal formulations, are prohibited.)
- Concurrent use of other immunomodulators, chemotherapy, investigational drugs, or long-term corticosteroid therapy will exclude the patient from enrollment.
- Patients with psychiatric disorders, substance abuse, or social issues that may compromise compliance, as assessed by the investigator, will be excluded.
- Patients with a known allergy or contraindication to the study treatment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Study on the Efficacy of MR-guided Online Adaptive Radiotherapy for Locally Advanced Rectal Cancer
Based on preliminary findings on the motion error of the clinical target volume (CTV) in MR-guided adaptive radiotherapy (MRgART) for locally advanced rectal cancer (LARC), this study aims to reduce CTV-to-PTV margins and evaluate the complete response (CR) rate following MRgART in LARC patients. Additionally, it will investigate the safety and tolerability of MRgART, as well as its impact on:
3-year organ preservation rate
Read more
Local recurrence rate in patients under a "watch-and-wait" approach
3-year overall survival (OS), disease-free survival (DFS), and local progression-free survival (LPFS).
Furthermore, by analyzing ADC maps of the gross tumor volume (GTV), this study will characterize treatment responses and spatial deformation in metabolically active tumor subregions. These insights may inform future dose-escalation strategies for LARC radiotherapy, with the ultimate goal of improving prognosis and quality of life in this patient population.
- Conditions
- Rectal Cancer, Adaptive Radiotherapy
- Being tested
- short course radiotherapy using MR-linac
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short course radiotherapy using MR-linacRadiation
Patients in the MRgART group will receive standard total neoadjuvant therapy (TNT) and surgical treatment, including short-course radiotherapy and chemotherapy, with the addition of immunotherapy at the investigator's discretion based on individual patient characteristics.
| Study group | Role | What they receive |
|---|---|---|
| MRgART group | Experimental | Not described Receives: Radiation: short course radiotherapy using MR-linac |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response (CR)
Absence of residual cancer cells on the final analysis of the tumor and lymph node
Measured: 8 weeks post chemoradiotherapy
Secondary outcomes (6)
adverse events (AE)
Toxicity including anorexia, nausea, vomiting, diarrhoea, dermatitis, proctitis, urinary frequency/urgency according to CTCAE criteria v5.0
Measured: 2 years after radiotherapy
organ preservation rate
Sphincter Preservation rates 8 weeks post chemoradiotherapy at surgery.Percentage of patients who underwent sphincter salvage surgery after chemoradiotherapy
Measured: 8 weeks after chemoradiotherapy
local recurrence rate (LCR)
Measured: From the completion of total neoadjuvant therapy (TNT) or post-surgery until 3 years post-treatment follow-up
disease-free survival (DFS)
Time from study entry to disease recurrence or death
Measured: From the completion of total neoadjuvant therapy (TNT) or post-surgery until 3 years post-treatment follow-up
overall survival (OS)
Time from study entry to death
Measured: From enrollment until 3 years post-treatment follow-up
local progression-free survival (LPFS)
Time from study entry to local recurrence
Measured: From the completion of total neoadjuvant therapy (TNT) or post-surgery until 3 years post-treatment follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TangYuan, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080411
- Sponsor's protocol ID
- 2025062017264502
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Efficacy of MR-guided Online Adaptive Radiotherapy for Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT07080411
- Acronym / sponsor ID
- 2025062017264502
- Conditions
- Rectal Cancer, Adaptive Radiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 23 Jul 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.
Based on preliminary findings on the motion error of the clinical target volume (CTV) in MR-guided adaptive radiotherapy (MRgART) for locally advanced rectal cancer (LARC), this study aims to reduce CTV-to-PTV margins and evaluate the complete response (CR) rate following MRgART in LARC patients. Additionally, it will investigate the safety and tolerability of MRgART, as well as its impact on:
3-year organ preservation rate
Local recurrence rate in patients under a "watch-and-wait" approach
3-year overall survival (OS), disease-free survival (DFS), and local progression-free survival (LPFS).
Furthermore, by analyzing ADC maps of the gross tumor volume (GTV), this study will characterize treatment responses and spatial deformation in metabolically active tumor subregions. These insights may inform future dose-escalation strategies for LARC radiotherapy, with the ultimate goal of improving prognosis and quality of life in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRgART group | Experimental | Radiation: short course radiotherapy using MR-linac |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-75 years, regardless of gender;
- Staged as II/III (cT3-T4N0 or cT2-4N+, no distant metastasis) by MRI or endoscopic ultrasound (according to the AJCC Cancer Staging Manual, 8th Edition);
- Fibrocolonoscopy or digital rectal examination confirms the lower border of the lesion is ≤10 cm from the anal verge;
- Pathologically confirmed or reviewed diagnosis of rectal adenocarcinoma;
- ECOG performance status of 0-1;
Key exclusion criteria (16 listed)
- Presence of MRI-incompatible metal implants or claustrophobia;
- Previous treatment with anti-PD-1/L1, anti-CTLA-4 immunotherapy, or other experimental immunotherapeutic drugs;
- History of severe autoimmune diseases, including active inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (e.g., Wegener's granulomatosis), etc.;
- Symptomatic interstitial lung disease or active infectious/non-infectious pneumonia;
- Risk factors for intestinal perforation, such as active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal malignancies, or other known predisposing conditions;
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 |
|---|---|---|
| short course radiotherapy using MR-linacPatients in the MRgART group will receive standard total neoadjuvant therapy (TNT) and surgical treatment, including short-course radiotherapy and chemotherapy, with the addition of immunotherapy at the investigator's discretion based on individual patient characteristics. | Radiation | MRgART group |
Primary outcome
complete response (CR)
Time frame: 8 weeks post chemoradiotherapy
Absence of residual cancer cells on the final analysis of the tumor and lymph node
6 secondary outcomes
adverse events (AE)
Time frame: 2 years after radiotherapy
organ preservation rate
Time frame: 8 weeks after chemoradiotherapy
local recurrence rate (LCR)
Time frame: From the completion of total neoadjuvant therapy (TNT) or post-surgery until 3 years post-treatment follow-up
disease-free survival (DFS)
Time frame: From the completion of total neoadjuvant therapy (TNT) or post-surgery until 3 years post-treatment follow-up
overall survival (OS)
Time frame: From enrollment until 3 years post-treatment follow-up
local progression-free survival (LPFS)
Time frame: From the completion of total neoadjuvant therapy (TNT) or post-surgery until 3 years post-treatment follow-up
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 23 Jul 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing short course radiotherapy using MR-linac in people with Rectal Cancer and Adaptive Radiotherapy, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
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 10 inclusion and 16 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: opening soon, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Yuan Tang (8610-87787631, tangyuan82@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete response (CR) (time frame: 8 weeks post chemoradiotherapy). 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 23 Jul 2025.