New adaptive radiation boosts rectal cancer response rates
NCT ID NCT07580027
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a personalized radiation approach for locally advanced rectal cancer. By adjusting the radiation dose halfway through treatment based on a special MRI scan, doctors hope to increase the number of patients whose tumors completely disappear before surgery. The trial will enroll 33 people to see if this method can raise the complete response rate from 41% to 70%.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radiation therapy (adaptive radiotherapy) and chemotherapy
- What this could lead to
- If successful, this approach could significantly increase the chance of eliminating the tumor before surgery, potentially reducing the need for more aggressive treatments.
- What could go wrong
- This is a small, early-phase study (33 participants) and the results may not apply to all patients. The treatment involves radiation and chemotherapy, which carry risks like fatigue, bowel issues, and skin reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 33 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Initial phase (standard phase). These criteria represent the conditions for which preoperative chemoradiotherapy treatment for rectal cancer is clinically indicated 1. Histologically confirmed rectal adenocarcinoma 2. Microsatellite status: stable 3. Stage T2N0 if lower rectal lesions are candidates for subsequent intersphincteric resection or abdominoperineal amputation with permanent colostomy 4. Stage T3-T4N0 or any T with positive lymph nodes 5. Lower margin of lesion no more than 12 cm from anal verge Adaptive radiotherapy phase (experimental phase) 6. ERI\_TCP \< 32.6 calculated as follows: ERITCP=-ln\[(1-(Vmid/Vpre)\]Vpre where Vpre is the volume of the rectal tumor pre-therapy, Vmid is the volume of the residual tumor still visible in the images of the MR intermediate to RT) 7. Lower margin of rectal lesion at least 1 cm from surgical resection line on images of the intermediate smc MRI 8. ECOG (Eastern Cooperative Oncology Group) Performance Status ≤ 2 9. Age: 18-80 years 10. Written informed consent Exclusion Criteria: 1. Distant metastases 2. Previous cancer excluding non-melanoma skin cancer diagnosed less than 5 years before rectal cancer appearance 3. Previous chemotherapy or radiotherapy to the pelvis 4. Contraindications to radiotherapy: active ulcerative colitis 5. Contraindications to chemotherapy: NE\<1.5x10/L, Plt \< 100x10/L), creatinine \>1,5mg/dl, bilirubin \> 2mg/dl, AST/ALT \> 3x normal upper limit, significant cardiac disease, peripheral neuropathy. 6. Pregnancy 7. Breastfeeding
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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I.R.C.C.S. San Raffaele Hospital
Milan, 20132, Italy
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Blood test aims to catch Cancer's return earlier
- Blood test guides immunotherapy for hidden cancer cells
- Can Pre-Surgery radiation stop rectal cancer from returning?