Introduction of the Maastro applicator for endoluminal boosting in rectal cancer: a pilot study

Conditions: rectal adenocarcinoma
rectal cancer
10017990
10017991
10017998

Registration Number: NL-OMON56474

Lead Sponsor: MAASTRO clinic

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

• >= 18 years of age and capable of giving informed consent.
• Adenocarcinoma of the rectum classified cT2-3ab, < 5 cm largest diameter and
< * circumference (MRI staging), N0-N1 (any node < 8 mm diameter), M0
• Operable patient
• Tumor accessible to the Maastro applicator with a distance from the lower
tumor border to the anal verge <=10 cm
• No comorbidity preventing treatment
• Adequate birth control for women of child-bearing potential
• Follow-up possible.

Exclusion Criteria

• Tumor extending into the anal canal.
• Stop of anti-coagulants (except <=100 mg aspirin/day) is medically
contraindicated.
• Presence of coagulation disorder resulting in an increased bleeding risk.
• Prior pelvic radiation therapy (excluding the abovementioned neoadjuvant
treatment).
• Prior surgery or chemotherapy for rectal cancer (excluding the abovementioned
neoadjuvant treatment).
• Inflammatory bowel disease (IBD).
• (Systemic) treatment possibly causing rectal or genitourinary toxicity for a
separate active malignancy.
• World Health Organization performance status (WHO-PS) >= 3.
• Life expectancy of < 6 months.
• Pregnant women.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To confirm clinical feasibility of the Maastro boosting technique. If at least<br /><br>7 out of 10 planned Maastro applicator treatment series (3 fractions per<br /><br>series) can be conducted successfully from a procedural point of view the<br /><br>treatment will be considered feasible.<br /><br><br /><br>The application procedure consists of several protocolised sequential steps. We<br /><br>have developed a checklist to score whether every procedural step has been<br /><br>completed adequately (appendix A of the study protocol). If all sub-items have<br /><br>been conducted successfully the procedure will be considered successful.</p><br>

Secondary Outcome Measures