Whole brain helical tomotherapy with integrated boost for brain metastases in patients with malignant melanoma – a randomized trial

Not Applicable

• Conditions: C79.3; C43; Secondary malignant neoplasm of brain and cerebral meninges; Malignant melanoma of skin

• Registration Number: DRKS00005127
• Lead Sponsor: niversitätsklinikum Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-03
• Study Completion: 2017-07-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• histologically confirmed malignant melanoma (MM)
• MR-imaging confirmed >1 cerebral metastases (in case of resection, >1 remaining metastases)
• age = 18 years of age
• Karnofsky Performance Score >/=60
• For women with childbearing potential, (and men) adequate contraception.
• Ability of subject to understand character and individual consequences of the clinical trial
• Written informed consent (must be available before enrolment in the trial)

Exclusion Criteria

• refusal of the patients to take part in the study
• previous radiotherapy of the brain
• Patients who have not yet recovered from acute high-grade toxicities of prior therapies
• Known carcinoma < 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
• Pregnant or lactating women
• Participation in another clinical study or observation period of competing trials, respectively
• MRI contraindication (i.e. cardiac pacemaker, implanted defibrillator, certain cardiac valve replacements, certain metal implants)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Toxicity quantified by absolute frequencies and percentages of side effects according to CTC Criteria Version 4. Follow-up visits every ~2 months for in total 1 year

Secondary Outcome Measures

Name	Time	Method
imaging response, local and loco-regional progression-free survival, overall survival and quality of life<br>Imaging response will be evaluated according to the RECIST criteria and represented by percentages. Kaplan-Meier curves will be plotted and Cox-regression analyses will be conducted to investigate possible factors influencing survival. QoL will be measured with the EORTC-QoL-Q C30 and brain module BN-20, and results will be summarized by median, minimum and maximum scores, and represented by box plots. Follow-up visits (as previously mentioned in section primary endpoint) every ~2 months for 1 year