Contact Radiotherapy for Rectal Cancer

Launched by ALEXANDER VALDMAN · Jul 11, 2024

Keywords

ClinConnect Summary

The CORRECT clinical trial is studying a new treatment approach for patients with early-stage rectal cancer. Specifically, it aims to compare a combination of Contact X-ray Brachytherapy (CXB) and short-course radiotherapy (SCRT) to an existing treatment to see if it can effectively preserve the rectum while treating the cancer. This trial is currently looking for participants who are between 18 and 74 years old and have a specific type of rectal cancer that is not too advanced. Eligible participants should have tumors that are small and can be treated with special techniques.

If you decide to join this trial, you will receive the new treatment and be monitored closely by a medical team to see how well it works for you. It's important to note that not everyone can participate; for instance, patients with more advanced cancer or certain medical conditions may not be eligible. Overall, this study aims to provide a safe and effective option for managing early rectal cancer, helping patients keep their organs while receiving necessary treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Adenocarcinoma of the rectum classified as:
• • cT1-cT3ab, \< 5 cm largest diameter and \< ½ circumference (MRI staging), N0-N1 (\<= 3 nodes \< 8mm diameter), M0
• • Performance status (ECOG) 0-1
• • Operable patient
• • Tumor accessible to endocavitary contact X-ray brachytherapy with a distance from the lower tumor border to the anal verge ≤10 cm
• • 18 years or above
• • No comorbidity preventing treatment
• • Patient having read the information note and having signed the informed consent
• • Follow-up possible
• Exclusion Criteria:
• • Inoperable patient
• • T3cd, T4, T≥ 5cm, Involvement of more than half of the bowel circumference
• • Distance from the lower tumor border to the anal verge \>10 cm
• • N2-status at diagnosis or N1 with any node\>= 8 mm diameter
• • Patient presenting with metastasis at diagnosis (M1)
• • Previous pelvic irradiation
• • Tumor with extramural vascular invasion
• • Poorly differentiated tumor
• • Simultaneous progressive cancer
• • Tumor invading external anal sphincter or growth within 1 mm of the levator
• • Tumor within 1 mm from MRF (mesorectal fascia)
• • Patient unable to receive CXB or CRT
• • Any significant concurrent medical illness that in the opinion of the investigator would preclude protocol therapy
• • Patient with history of poor compliance or current or past psychiatric conditions or severe acute or chronic medical conditions that would interfere with the ability to comply with the study protocol
• • Concurrent enrolment in another clinical trial using an investigational anti-cancer treatment within 28 days prior to the first dose of study treatment
• • Total DPD deficiency