Adaptive Boost Radiotherapy to Primary Lesions and Positive Nodes in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer

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.

Eligibility

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.

Conditions2

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