NCT04927897 DETECT: Target Volume for Rectal Endoluminal Radiation Boosting
| NCT ID | NCT04927897 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maastricht Radiation Oncology |
| Condition | Rectal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2022-08-16 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2022-08-16 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of the study is to provide prospective data regarding microscopic tumor spread in all directions from the macroscopic tumor in pathology specimens, as seen by eye, and on imaging to define the target volume for endoluminal radiation boosting in rectal cancer patients.
Eligibility Criteria
Inclusion Criteria: * ≥18 years of age and capable of giving informed consent. * ycT1-3N0(\*) residual(\*\*) histology confirmed rectal adenocarcinoma after neoadjuvant radiotherapy or long-course chemoradiotherapy for which patients will undergo TME surgery. * Minimal interval between end of neoadjuvant chemoradiotherapy or radiotherapy: 6 weeks. (\*)= as determined by clinical assessment (digital rectal examination, endoscopy with or without biopsy) and/or MRI. Biopsy/histology around the time of diagnosis is adequate; no biopsy/histology is needed after neoadjuvant therapy. (\*\*)= including tumor regrowths/local recurrence after an initial clinical complete response and a "watch and wait" approach. These patients will also be included after the local recurrence has been determined using endoscopy and/or MRI. Exclusion Criteria: * Patient has received brachytherapy as part of neoadjuvant treatment. * \<18 years of age or incapable of giving informed consent. * Patient has not been treated with neoadjuvant radiotherapy or long-course chemoradiotherapy. * Patient will not undergo TME surgery for a ycT1-3N0 residual histology confirmed rectal adenocarcinoma. * Interval between end of neoadjuvant therapy and surgery is \<6 weeks.
Contact & Investigator
Maaike Berbée, MD, PhD
PRINCIPAL INVESTIGATOR
Maastro
Frequently Asked Questions
Who can join the NCT04927897 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04927897 currently recruiting?
Yes, NCT04927897 is actively recruiting participants. Contact the research team at maaike.berbee@maastro.nl for enrollment information.
Where is the NCT04927897 trial being conducted?
This trial is being conducted at Maastricht, Netherlands, Maastricht, Netherlands, Eindhoven, Netherlands.
Who is sponsoring the NCT04927897 clinical trial?
NCT04927897 is sponsored by Maastricht Radiation Oncology. The principal investigator is Maaike Berbée, MD, PhD at Maastro. The trial plans to enroll 50 participants.
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