What is this study trying to find out about rectal cancer?

This study is evaluating whether giving a higher radiation dose to the tumor can help preserve the rectum without surgery for patients with non-locally advanced rectal cancer. Researchers want to improve treatment options that reduce long-term side effects and improve quality of life. The study is led by Claudia Schuurhuizen.

Who may be eligible for this rectal cancer clinical trial?

Adults aged 18 years or older with confirmed non-locally advanced rectal adenocarcinoma who are suitable for organ preservation may be eligible. Both men and women can participate. Important factors include no prior pelvic radiotherapy or local tumor surgery and the ability to consent. Please review eligibility criteria for more details.

Is there any cost to participate in this rectal cancer clinical trial?

Study-related care, including the radiation treatment and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID07616297

Using CBCT-Based Adaptive Radiotherapy Boost to Improve Organ Preservation in Non-Locally Advanced Rectal Cancer

Led by Claudia Schuurhuizen · Updated on 2026-06-01

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating whether a higher radiation dose to the tumor can increase the rate of preserving the rectum in patients with non-locally advanced rectal cancer. This prospective study focuses on patients who want to avoid surgery and aims to improve quality of life by reducing long-term side effects. The trial explores a new radiation approach using cone-beam computed tomography CBCT for more accessible and adaptive treatment compared to MRI-guided methods. The study involves adding a simultaneous integrated boost SIB to the standard chemoradiotherapy regimen. Patients receive 25 radiation sessions where the mesorectum gets 2.0 Gy per fraction and the tumor plus affected lymph nodes receive 2.4 Gy per fraction. This single-arm trial includes 25 patients and uses CBCT imaging daily to guide treatment and monitor tumor and organ movement. Participants will have five MRI scans during treatment weeks, complete questionnaires at five time points, and provide blood samples to assess treatment effects and safety. Researchers will track organ preservation rates over two years, clinical and pathological responses, survival outcomes, bowel function, quality of life, and any treatment-related toxicities. The total follow-up lasts up to three years for some outcomes, with regular assessments to understand the effectiveness and impact of this adapted radiation therapy.

CONDITIONS

Brief Title

Higher Radiation Dose to the Tumor May Help Avoid Surgery in Rectal Cancer Patients

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older
Eastern Cooperative Oncology Group (ECOG) performance status 2 or less
Histologically confirmed rectal adenocarcinoma
Non-locally advanced rectal cancer defined as MRI-based T1-3, N0/N1 (up to 3 positive mesorectal lymph nodes), MX/M0
Suitable for curative treatment aiming for organ preservation
Case discussed in multidisciplinary tumor board
Provided written informed consent

You will not qualify if you...

Previous radiotherapy in the pelvic area
Other cancers except adequately treated basal cell carcinoma within 3 years prior
Contraindications for chemoradiotherapy or surgery
Presence of lateral lymph nodes, cN2 status, extramural vascular invasion, or mesorectal fascia involvement on MRI
Mucinous type tumor on MRI
Prior local excision of the primary tumor
Dihydropyrimidine dehydrogenase (DPD) deficiency
Unable to understand study requirements or provide informed consent as determined by physician

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