NCT06246344Active, not recruitingPhase 3
Adaptive Boost Radiotherapy to Primary Lesions and Positive Nodes in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer
Online Adaptive Radiotherapy With a Boost to the Primary Tumor and Clinically Involved Lymph Nodes in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer: A Prospective, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
This prospective, single-center, randomized controlled trial evaluates whether online adaptive radiotherapy (ART) with a sequential boost to both the primary rectal tumor and clinically involved lymph nodes improves pathologic complete response in patients with high-risk, node-positive locally advanced rectal cancer. Participants were randomly assigned 1:1 to online ART with a sequential boost or conventional non-adaptive intensity-modulated radiotherapy (IMRT). Both groups received concurrent capecitabine during long-course chemoradiotherapy, followed by 3-4 cycles of CAPEOX consolidation chemotherapy and planned total mesorectal excision. The planned sample size was 128 participants. Enrollment was discontinued after an interim review after 76 participants had been randomized; long-term follow-up of enrolled participants is ongoing.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 128 (estimated)
- First submitted
- 28 Jan 2024
- Start date
- 1 Dec 2023
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Diseases
- Colorectal cancer
- NCT number
- NCT06246344
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 128
- From 1 Dec 2023 to the primary completion date, 1 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior pelvic radiotherapy.
- Prior rectal surgery for the index cancer, including local excision or transanal procedures.
Other illness
- Locally recurrent rectal cancer.
- Active inflammatory bowel disease.
- History of another primary malignancy within the preceding 5 years, except adequately treated non-melanoma skin cancer or carcinoma in situ.
- Severe or uncontrolled medical condition contraindicating chemoradiotherapy or surgery.
- Clinically significant hypersensitivity to protocol systemic therapy that precludes treatment.
Other
- Radiologically or pathologically confirmed distant metastasis.
- Pregnancy or lactation.
Who the study is looking for
- Age 18 years or older.
- ECOG performance status of 0 or 1.
- Histologically confirmed rectal adenocarcinoma.
- Primary tumor located within 10 cm of the anal verge by pelvic MRI and/or rigid sigmoidoscopy.
- Clinically involved regional lymph nodes (cN1-2) according to the AJCC 8th edition.
- At least one additional high-risk feature: cT4 disease, cN2 disease, extramural vascular invasion, mesorectal fascia involvement, lateral pelvic lymph-node involvement, tumor deposits, or low rectal cancer (≤5 cm from the anal verge).
- Baseline locoregional staging with contrast-enhanced pelvic MRI and chest/abdominal imaging excluding distant metastases.
- Treatment-naïve with respect to systemic therapy and pelvic radiotherapy for the index rectal cancer and suitable for total mesorectal excision.
- Adequate organ function and no medical contraindication to chemoradiotherapy.
- Written informed consent before study-specific procedures.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Radiation Oncology, Shandong Cancer Hospital and Institute Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.