Contact radiotherapy for rectal cancer treatment

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 study aims to evaluate the effectiveness of a combination of Contact x-ray brachytherapy (CXB) and short-course radiotherapy (SCRT) in preserving organs for patients with early and early intermediate rectal cancer. Participants will be randomly assigned to receive either the standard treatment of CXB combined with chemoradiotherapy or the experimental treatment of CXB with SCRT. The primary goal is to determine if the new treatment is non-inferior in terms of the two-year organ preservation rate while potentially reducing side effects compared to existing therapies. This approach is particularly relevant for patients who may not tolerate more intensive treatments.

Why it matters

Who can join: the full rules

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

Where it's running

• Karolinska University Hospital, Theme Cancer, Dept of Pelvic cancer
  Stockholm, Solna, Sweden Recruiting
• Uppsala University Hospital, Colorectal Surgery
  Uppsala, Sweden Recruiting

Study contacts

• Study coordinator: Alexander Valdman, MD, PhD
• Email: alexander.valdman@regionstockholm.se
• Phone: +46 70 002 13 17

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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.