Skip to content

Feasibility study of external beam radiation therapy followed by high-dose rate endorectal brachytherapy (HDRBT) in inoperable rectal cancer patients

Feasibility study of external beam radiation therapy followed by high-dose rate endorectal brachytherapy (HDRBT) in inoperable rectal cancer patients - Feasibility of brachytherapy in rectal cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30965
Enrollment
20
Registered
2007-08-15
Start date
2007-06-01
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rectal cancer

Interventions

External beam raditoherapy 39 Gy will be given in 13 fractions of 3 Gy in 21 days After 6 weeks a MRI will be performed and if the tumor thickness is: * tumor 2 cm, patients will be treated with bra

Sponsors

Antoni van Leeuwenhoek Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Histologically verified adenocarcinoma of the rectum within 15 cm of the anal verge, = 6 months -Patients who are unfit for surgical treatment, due to co-morbidity, or patients who refuse surgery -WHO

Exclusion criteria

Exclusion criteria: -Pregnant women -Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Design outcomes

Primary

MeasureTime frame
To determine the feasibility and the maximum tolerated radiation dose in HDRBT of the rectum after EBRT in rectal cancer patients who are unfit for surgery or refuse surgery

Secondary

MeasureTime frame
*To determine the incidence and severity of acute and late toxicity of EBRT followed by HDRBT *To determine the patient*s sphincter function *To determine the clinical tumor response of EBRT followed by HDRBT *To correlate the isodose lines of the irradiated tumor and normal tissue volumes with toxicity (HDRBT)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)