Adaptive Boost Radiotherapy for 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
This study is testing a new type of targeted radiotherapy combined with chemotherapy to see if it can help people with locally advanced rectal cancer have better treatment results.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 128 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shandong Cancer Hospital and Institute Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06246344 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of adaptive boost radiotherapy combined with concurrent chemotherapy in patients with locally advanced rectal cancer. The approach focuses on targeting both primary tumors and positive lymph nodes to improve treatment outcomes. By utilizing advanced imaging techniques like MR or CBCT, the study aims to optimize radiotherapy delivery and enhance tumor regression. The trial includes a multicenter, randomized, controlled design to ensure robust data collection and analysis.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histopathologically confirmed rectal adenocarcinoma located within 10 cm of the anal verge and suitable for chemoradiotherapy.
Not a fit: Patients with a history of prior treatments for rectal cancer or those with locally recurrent disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve tumor response rates and reduce local recurrence in patients with locally advanced rectal cancer.
How similar studies have performed: While there have been studies on dose escalation in radiotherapy for rectal cancer, this specific approach of adaptive boost radiotherapy targeting both primary lesions and lymph nodes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Jinan, Shandong
- Department of Radiation Oncology, Shandong Cancer Hospital and Institute — Jinan, Shandong, China (Recruiting)
Study contacts
- Principal investigator: Jinbo Yue, Doctor — Shandong Cancer Hospital and Institute
- Study coordinator: Jinbo Yue, doctor
- Email: jbyue@sdfmu.edu.cn
- Phone: 0531-67626442
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.