HDR endorectal brachytherapy with 3D-printed guidance and shielding for organ-preserving rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm phase II trial evaluating a non-operative treatment strategy for localized rectal cancer. Eligible patients have histologically confirmed rectal adenocarcinoma without distant metastases and are unsuitable or unwilling to undergo radical surgery, or are deemed technically unresectable. Participants receive pelvic external beam radiotherapy, with potential concurrent capecitabine, followed by HDR endorectal brachytherapy guided by patient-specific 3D-printed templates and local tungsten shielding to spare non-target rectal tissue. The regimen includes a planned external beam total of 45 Gy to the planning target volume, with possible boosts to involved nodes, and an HDR boost of 6 Gy per fraction for 3 fractions. Reassessment occurs 4-6 weeks after external-beam radiotherapy before HDR delivery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18-80 years.
2. Histologically confirmed rectal adenocarcinoma.
3. Clinical stage cT2-4, any N, M0.
4. Patients who are elderly or frail, medically unsuitable for radical surgery, refuse radical surgery, or are considered by a multidisciplinary team (MDT) to have disease for which safe R0 resection is technically difficult.
5. Considered by the MDT and investigators to be suitable for a definitive non-operative treatment strategy.
6. ECOG performance status 0-2; patients with ECOG performance status 3 may be eligible if considered by the MDT to be able to tolerate the study treatment.
7. Estimated life expectancy of at least 6 months.
8. Considered suitable for pelvic external beam radiotherapy and HDR endorectal brachytherapy.
9. Tumor location, endorectal access, and local anatomy suitable for HDR brachytherapy using the individualized 3D-printed guide template.
10. Adequate hematologic, hepatic, and renal function for the planned treatment.
11. Ability to understand the study requirements and provide written informed consent.

Exclusion Criteria:

1. Distant metastatic disease or disease considered unsuitable for definitive local non-operative treatment.
2. Prior definitive pelvic radiotherapy.
3. Intestinal perforation, complete bowel obstruction, uncontrolled active bleeding, or severe active infection.
4. Anatomical or clinical conditions precluding HDR endorectal brachytherapy or use of the individualized guide template/local shielding platform.
5. Inflammatory bowel disease.
6. Severe uncontrolled cardiopulmonary disease, significant bone marrow suppression, or severe hepatic or renal dysfunction.
7. Pregnancy or breastfeeding.
8. Concurrent participation in another clinical trial that may interfere with evaluation of the study treatment or endpoints.
9. Any other condition considered by the investigator to make the patient unsuitable for participation in the study.

Where it's running

• Tianjin Medical University Cancer Institute and Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Principal investigator: Yuanjie Cao, MD — Tianjin Medical University Cancer Institute and Hospital
• Study coordinator: Yuanjie Cao, MD
• Email: cyjro325@tjmuch.com
• Phone: 86-18522123151

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.