Adaptive Boost Radiotherapy to Primary Lesions and Positive Nodes in the Neoadjuvant Treatment of… (NCT06246344) | Clinical Trial Compass
SuspendedNot Applicable
Adaptive Boost Radiotherapy to Primary Lesions and Positive Nodes in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer
Stopped: The study was terminated early for futility based on the interim analysis. The results indicated a low probability of achieving the primary endpoint.
China128 participantsStarted 2023-12-01
Plain-language summary
This is a multicenter, randomized, controlled phase III trial to evaluate the efficacy and safety of adaptive boost radiotherapy to the primary lesions and positive lymph nodes based on MR or CBCT or FBCT-guided adaptive radiotherapy in the neoadjuvant treatment of locally advanced rectal cancer.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histopathologically confirmed rectal adenocarcinoma.
* Tumor located ≤10cm from the anal verge.
* Age ≥18 years.
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1.
* Primary treatment-naive tumor confirmed by endorectal ultrasound (ERUS) or -
* Magnetic resonance imaging (MRI) as cT3-4/N+ according to the 8th edition of AJCC staging.
* Ability to provide tissue and blood samples for translational research.
* Anticipated survival of ≥6 months.
* Normal major organ function (within 14 days prior to enrollment) and suitability for receiving chemoradiotherapy.
Exclusion Criteria:
* History of prior chemotherapy, radiotherapy, or surgical treatment for rectal cancer, including transanal tumor resection.
* Locally recurrent rectal cancer.
* History of familial adenomatous polyposis.
* Active Crohn's disease or ulcerative colitis.
* Allergy or hypersensitivity history to 5-fluorouracil (fluorouracil) and/or oxaliplatin.
* History of difficulty or inability to take or absorb oral medications.
* Diagnosis of malignancy other than rectal cancer within the past 5 years (excluding completely cured basal cell carcinoma, squamous cell carcinoma of the skin, and/or in situ carcinoma treated with radical resection).
* Confirmed distant metastasis, i.e., cM1, through imaging or biopsy.
* History of pelvic radiotherapy.
* Pregnant or lactating women.
* Presence of any severe or uncontrollable systemic illness.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.