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Adaptive Boost Radiotherapy to Primary Lesions and Positive Nodes in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer
Sponsor: Shandong Cancer Hospital and Institute
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.
Official title: Efficacy and Safety of Adaptive Boost Radiotherapy to Primary Lesions and Positive Nodes in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer: A Prospective, Randomized, Controlled, Phase III Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
OBSERVATIONAL
Enrollment
128
Start Date
2023-12-01
Completion Date
2028-12-01
Last Updated
2025-03-12
Healthy Volunteers
No
Conditions
Interventions
Adaptive Boost Radiotherapy
The choice of adaptive protocol and delivery system is based on individual tumor characteristics, patient anatomy and institutional capabilities. This approach provides flexibility in treatment planning while adhering to evidence-based dose constraints. Adaptive radiotherapy is delivered using one of the following advanced platforms: the Elekta Unity MRI Linac (MR-guided) or Varian Ethos (CBCT-guided), or the United Imaging uRT-linac 506c (FBCT-guided). ART Option 1 (simultaneous integrated boost, SIB): GTVp+GTVn: A total dose of 60-65 Gy delivered in 25 fractions using a simultaneous integrated boost approach. CTV: A total dose of 45-50 Gy delivered in 25 fractions. ART Option 2 (sequential boost, SB) GTVp+GTVn: An initial hypofractionated boost with a total dose of either 9-12 Gy delivered in 3 fractions or 10 Gy delivered in 2 fractions. CTV: Followed by standard fractionation delivering 45-50 Gy in 25 fractions.
Long course non-ART radiotherapy
Conventional long-course radiotherapy administered in a non-adaptive manner without dose escalation. Treatment will be targeted to the pelvic lymphatic drainage region only. A total dose of 45-50 Gy will be delivered in 25 fractions over the course of treatment.
Concurrent chemotherapy
Capecitabine (825 mg/m2, po, twice daily)
Consolidation Chemotherapy
Following the completion of concurrent chemoradiotherapy, consolidation chemotherapy will commence 7 to 10 days later. Patients will receive two cycles of the CAPEOX regimen. Each cycle comprises: Capecitabine: 1.0 g/m² administered orally twice daily on days 1 through 14, and Oxaliplatin: 130 mg/m² administered intravenously on day 1.
Total mesorectal excision (TME) surgery
Total mesorectal excision surgery
Locations (1)
Department of Radiation Oncology, Shandong Cancer Hospital and Institute
Jinan, Shandong, China