Carbon ion boost versus proton boost after radiochemotherapy with temozolomide in patients with primary glioblastoma

Phase 2

Completed

• Conditions: Primary glioblastoma; Cancer; Malignant neoplasm of brain

• Registration Number: ISRCTN37428883
• Lead Sponsor: niversity Hospital of Heidelberg (Germany)

Brief Summary

2010 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/20819220 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-08
• Study Completion: 2013-10-31
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Histologically confirmed unifocal, supratentorial primary glioblastoma
2. Macroscopic tumour after biopsy or subtotal resection
3. Indication for combined radiochemotherapy with temozolomide
4. Prior photon irradiation of 50 Gy to the T2-hyperintense area, resection cavity, areas of contrast enhancement adding 2 - 3 cm safety margin
5. Registration prior to photon RT or within photon RT allowing the beginning of C12 greater than or equal to 4 days after completion of photon irradiation
6. Beginning of study treatment (proton or carbon ion RT) no later than 10 weeks after primary diagnosis
7. Aged greater than or equal to 18 years, either sex
8. Karnofsky Performance Score less than or equal to 60
9. Life expectancy greater than 12 weeks
10. For women with childbearing potential, (and men) adequate contraception
11. Ability of subject to understand character and individual consequences of the clinical trial
12. Written informed consent (must be available before enrolment in the trial)

Exclusion Criteria

1. Refusal of the patients to take part in the study
2. Previous radiotherapy of the brain or chemotherapy with dacarbazine (DTIC) or TMZ
3. More than 50.4 Gy applied via photon-RT prior to carbon ion RT
4. Time interval of greater than 10 weeks after primary diagnosis and beginning of study treatment (proton or carbon ion RT)
5. Patients who have not yet recovered from acute toxicities of prior therapies
6. Clinically active kidney-liver or cardiac disease
7. Known carcinoma less than 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
8. Human immunodeficiency virus (HIV)
9. Pregnant or lactating women
10. Participation in another clinical study or observation period of competing trials, respectively

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival during the follow-up phase of at least 12 months (starting with initial diagnosis)

Secondary Outcome Measures

Name	Time	Method
<br> 1. Progression-free survival<br> 2. Safety<br> 3. Toxicity<br>