New radiation approach aims to control inoperable rectal cancer recurrence
NCT ID NCT07297004
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial is testing whether a high-precision radiation technique called stereotactic body radiation therapy (SBRT) can help control locally recurrent rectal cancer that cannot be surgically removed. The study will enroll 40 adults aged 18-75 with unresectable tumors and no distant spread. The main goal is to see if SBRT can improve the chance that the cancer does not grow for at least one year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Stereotactic body radiation therapy (SBRT)
- What this could lead to
- If successful, this could offer a non-surgical option to control tumor growth in patients with recurrent rectal cancer that cannot be removed by surgery.
- What could go wrong
- This is a small, early-phase study with only 40 participants and no comparison group. The expected improvement in local control is modest (from 20% to 40%), and results may not apply to all patients.
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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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Nov 2026
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 75 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: 1. Written informed consent; 2. 18-75 years of age; 3. Histologically, cytologically, or radiologically confirmed tumor recurrence, and the MDT assesses that the recurrent lesion cannot achieve R0 resection (unresectable defined as: 1) Pelvic MRI shows infiltration of S2 or above, 2) and/or lateral pelvic invasion, 3) and/or neurovascular invasion of the pelvic, 4) No indication for R0 resection after MDT discussion); 4. No clear distant metastasis at the time of diagnosis of locally recurrent rectal adenocarcinoma or MDT assesses that oligometastatic lesions are resectable or controlable (UICC 8th edition); 5. No previous radiotherapy for initial treatment, or more than 6 months between completion of initial radiotherapy and start of re-radiotherapy, with a previous radiotherapy dose of less than 50.4 Gy, and no grade 3-4 radiotherapy side effects in the small intestine or bladder; 6. ECOG score for performance status is 0-1 (Appendix 1); 7. Peripheral blood cell counts and liver and kidney function within the following acceptable ranges (tested within 15 days before treatment): * White blood cell count more than 3.0×10\^9/L or neutrophils more than 1.5×10\^9/L; * Hemoglobin more than 80 g/L; ③ Platelets more than 100×10\^9/L; ④ ALT or AST less than 3 times the upper limit of normal; ⑤ Total bilirubin less than 1.5 times the upper limit of normal; ⑥ Creatinine less than 1.5 times the upper limit of normal; 8. No history of other malignant tumors, non-pregnant or lactating patients, participants must use effective contraception during the study and for 6 months after the last treatment; 9. Expected survival more than 12 months. Exclusion Criteria: 1. Patients with a history of severe allergies to drugs, including platinum-based drugs, 5-FU, LV, and 5-HT3 receptor antagonists; 2. Patients who have participated in or are participating in other clinical trials within 4 weeks of enrollment; 3. Severe electrolyte abnormalities; 4. Presence of gastrointestinal diseases, such as active ulcers in the stomach or duodenum, ulcerative colitis, or unresected tumors that are actively bleeding; or other conditions that may lead to gastrointestinal bleeding or perforation; or unhealed gastrointestinal perforation after surgical treatment; 5. History of arterial thrombosis or deep vein thrombosis within 6 months; evidence of bleeding history or bleeding tendency within 2 months; 6. Pregnant or lactating women or women with a positive pregnancy test before the first medication; or female participants and their partners unwilling to strictly use contraception during the study; 7. Brain metastases with a diameter greater than 3 cm or a total volume greater than 30 cc; 8. Clinical or radiological evidence of spinal cord compression, or tumors within 3 mm of the spinal cord on MRI; 9. History of other active malignant tumors (except for those who have received curative treatment and have been disease-free for over 3 years or in situ cancers that can be cured with adequate treatment); 10. Severe ECG abnormalities, active coronary artery disease, or severe and uncontrolled angina, newly diagnosed angina, or myocardial infarction within 12 months before participating in the study, congestive heart failure of NYHA class II or above; 11. Patients with active infections (fever above 38°C due to infection); 12. Patients with poorly controlled hypercalcemia, high blood pressure, or diabetes; 13. Patients with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.); 14. Patients with mental disorders affecting clinical treatment or a history of central nervous system diseases; 15. Patients with severe complications (intestinal obstruction, renal failure, liver failure, cerebrovascular disorders, etc.); 16. Any unresolved toxicity from previous treatments that is grade 2 or higher according to CTCAE (excluding anemia, alopecia, skin pigmentation); 17. Any medical condition that is unstable or may affect patient safety and study compliance; 18. Patients deemed unsuitable for participation in this study by the investigator.
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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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The Sixth Affiliated Hospital, Sun Yat-sen University
RECRUITINGGuangzhou, Guangdong, 510655, China
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