RecruitingNCT06246344

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

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

Sponsor

Shandong Cancer Hospital and Institute

Enrollment

128 participants

Start Date

Dec 1, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a radiation approach called adaptive boost radiotherapy for rectal cancer — where the radiation dose to the primary tumor and involved lymph nodes is increased (boosted) and adjusted in real time using MRI guidance as the tumor changes shape during treatment, all given before surgery (neoadjuvant therapy). **You may be eligible if...** - You are 18 or older - You have been diagnosed with rectal adenocarcinoma (a type of rectal cancer confirmed by biopsy) - Your tumor is in the lower rectum (within 10 cm of the anal opening) - Your cancer is locally advanced (classified as cT3-4 or node-positive on MRI or ultrasound) - You have not received prior chemotherapy, radiation, or surgery for this rectal cancer - Your general health allows for chemoradiotherapy (combined chemo and radiation) **You may NOT be eligible if...** - You have had prior rectal cancer treatment of any kind - Your cancer is locally recurrent (came back in the same area) - You have inflammatory bowel disease - You have metastatic disease (cancer spread to other organs) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

RADIATIONAdaptive 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.

RADIATIONLong 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.

DRUGConcurrent chemotherapy

Capecitabine (825 mg/m2, po, twice daily)

DRUGConsolidation 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.

PROCEDURETotal mesorectal excision (TME) surgery

Total mesorectal excision surgery

Locations(1)

Department of Radiation Oncology, Shandong Cancer Hospital and Institute

Jinan, Shandong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06246344

Related Trials

Neoadjuvant Radiotherapy for Rectal Adenocarcinoma With Capecitabine Versus TAS-102 (Neo-REACT): A Multi-center, Randomized, Phase III Trial

NCT068500901 location

Low Rectal Cancer Treated With Total Neoadjuvant Therapy Plus Concurrent Tislelizumab Immunotherapy

NCT075610601 location

Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer

NCT075282091 location

Watch and Wait in PD-1 Monoclonal Antibody Treated dMMR/MSI-H Distal Rectal Cancer

NCT046430411 location

Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients

NCT031909411 location