Cavity Boost Radiation Therapy vs. Observation in Cerebral Metastases After Complete Surgical Resection

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT02887651

Studienbeginn:
November 2016

Letztes Update:
22.03.2022

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplasm Metastasis

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Heinrich-Heine University, Duesseldorf

Collaborator:
-

Studienleiter

Michael Sabel, Prof. Dr.
Principal Investigator
Department of Neurosurgery

Wilfried Budach, Prof. Dr.
Principal Investigator
department of radiation oncology

Kontakt

Marcel A. Kamp, MD
Kontakt:
Phone: 0049 - 211 - 81 - 07461
E-Mail: marcelalexander.kamp@med.uni-duesseldorf.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Heinrich-Heine-University
40225 Düsseldorf
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Marcel A. Kamp, MD
Phone: 0049-211-81-07461
E-Mail: marcelalexander.kamp@med.uni-duesseldorf.de» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

The surgical resection of cerebral metastases as a key element in a multimodal therapeutic

concept of brain metastatic patients is included in the common recommendations and

international guidelines (level I evidence). These recommendations are based on a series of

prospective, randomized and controlled studies which addressed the impact of the surgical

metastases resection combined with a whole-brain radiation therapy (WBRT) in comparison to

WBRT alone. Achieving local tumor control is the major goal of surgery and local tumor

control rate after surgery alone has been addressed in few studies: A prospective, randomized

American multicenter study revealed a local recurrence rate of 46% by median follow-up of 43

weeks for patients who underwent surgery alone without an adjuvant radiation therapy.

Similarly, the 2-year local recurrence rate after metastases resection alone was 53.1% in a

retrospective Korean study and 59% in the prospective, randomized and controlled EORTC

22952-26001 study.

In conclusion, standard surgery alone is not sufficient to achieve local control in about 50%

of patients (evidence level I). Therefore, surgery of cerebral metastases is often followed

by an adjuvant radiation therapy, which is an important part of a multi-modal therapy.

Evidence for an additional adjuvant whole-brain radiation therapy (WBRT) after surgical

resection was gained from a first prospective, randomized study in 1998: Patients treated by

surgery followed by adjuvant WBRT had a significant lower local in-brain progression rate as

compared to patients randomized to surgery alone (46% with a median follow-up of 48 weeks in

the observation group vs. 10% with a median follow-up of 43 weeks). This result was recently

confirmed by the EORTC 22952-26001 study: The 2-year local in-brain progression rate after

surgical resection was reduced by a WBRT from 59% to 27%. But despite the lower local and

also lower distant in-brain progression rate, the WBRT had no significant influence on the

overall survival. The additional analysis of the quality of life data of the EORTC

22952-26001 study showed, that a WBRT negatively impacts the health-related quality of life

with a statistically relevant and clinically significant impairment of the physical

functioning (at 8 weeks), cognitive functioning and of the global health status. In

conclusion, WBRT after surgery of cerebral metastases significantly reduces the incidence of

local recurrences but has no impact on the overall survival and has a significant negative

impact on the patient´s quality of life and cognitive function. Therefore, WBRT is not

mandatory as adjuvant concept after surgical metastases resection and does not have an

additional oncological impact in comparison to observation.

A local fractionated radiation therapy in analogy to the WBRT might achieve a similar local

tumor control than observation alone but might be associated with an improved cognitive

functioning as compared to WBRT. The purpose of this study is to determine whether a local

fractionated radiation therapy achieves a better local tumor control after complete surgical

metastases resection at 6 month as compared to observation alone. Further it should be

evaluated if cognitive functioning and quality of life is similar in both groups.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- histologically confirmed metastasis of carcinoma (except small cell carcinoma) or

malignant melanoma

- 1-3 metastases in the preoperative MRI

- Karnofsky Performance Status (KPS) ≥ 70

- Age > / = 18 years

- Recursive partitioning analysis (RPA) 1-2

- life expectation ≥ 6 months

- no previous irradiation of the brain

- MRI examinations possible

- start of the radiation therapy possible within 6 weeks after surgery

- informed consent

Exclusion Criteria:

- confirmation of residual tumor in the postoperative MRI

- dementia or disease of central nervous system with a higher risk or radiogenic

toxicity

- contraindication for MRIs or lack of acceptance for a MRI

- Glasgow Coma Scale < 12

- Severe concomitant disease: severe cardiac, pulmonary, renal diseases with an

increased risk of surgery and radiation

- previous therapeutic irradiation of the brain

- no histological confirmation of carcinoma metastases or malignant melanoma metastases

- cerebral metastases of small cell cancer, undifferentiate neuro-endocrine carcinoma,

lymphoma, leucemia, sarcoma or germ cell tumor

- leptomeningeal carcinosis

- distance of the cerebral metastasis to the optic system or radiation sensible brain

parts < 10 mm

- metastases of the brain stem, Di- or Mesencephalons, Pons oder Medulla oblongata

- bone marrow dysfunction

- contrast agent allergy

- pregnancy

Studien-Rationale

Primary outcome:

1. Local tumor control of resected metastases at 6 month (Time Frame - 6 month):
Primary outcome measure is the local tumor control of resected metastases after local cavity boost radiation therapy or observation at 6 month

Secondary outcome:

1. Local tumor control of resected metastases at 12 and 18 month (Time Frame - 12, 18 month):
Secondary outcome measure is the local tumor control of resected metastases after local cavity boost radiation therapy or observation at 12 and 18 month

2. Distant tumor control of resected metastases at 6, 12 and 18 month (Time Frame - 6, 12 and 18 month):
Secondary outcome measure is the distant tumor control at 6, 12 and 18 month

3. Incidence of leptomeningeal carcinosis (Time Frame - 6, 12 and 18 month):
Secondary outcome measure is the incidence of a leptomeningeal carcinosis at 6, 12 and 18 month

4. Eortc qlq bn20 questionaire (Time Frame - 3, 6, 9 12, 15, 18 month):
Secondary outcome measure is the patients quality of life at 3, 6, 9 12, 15, 18 month as assessed by the Eortc qlq bn20 questionaire

5. Eortc qlq c30 questionaire (Time Frame - 3, 6, 9, 12, 15, 18 month):
Secondary outcome measure is the patients quality of life at 3, 6, 9, 12, 15 and 18 month as assessed by the Eortc qlq c30 questionaire

6. Mini-Mental State Examination (MMSE) (Time Frame - 3, 6, 9 12, 15, 18 month):
Secondary outcome measure is the patients neurocognitive functioning at 3, 6, 9 12, 15 and 18 month as assessed by the MMSE

7. Hopkins Verbal Learning Test (HVLT) (Time Frame - 3, 6, 9 12, 15, 18 month):
Secondary outcome measure is the patients neurocognitive functioning at 3, 6, 9, 12, 15 and 18 month as assessed by the Hopkins Verbal Learning Test (HVLT),

8. Controlled Oral Word Association (COWA) (Time Frame - 3, 6, 9 12, 15, 18 month):
Secondary outcome measure is the patients neurocognitive functioning at 3, 6, 9 12, 15 and 18 month as assessed by the Controlled Oral Word Association (COWA)

9. Test and Trail-Making Test (TMT) A & B (Time Frame - 3, 6, 9 12, 15, 18 month):
Secondary outcome measure is the patients neurocognitive functioning at 3, 6, 9 12, 15 and 18 month as assessed by the Test and Trail-Making Test (TMT) A & B

Studien-Arme

No Intervention: observation
patients in the observation arm receive no adjuvant local radiation therapy after complete surgical resection of a cerebral metastasis
Active Comparator: cavity boost radiation therapy
patients in the intervention arm receive an adjuvant local radiation therapy (cavity boost radiation therapy: 10 x 3 Gy ad 30 Gy; clinical target volume (CTV): resection cavity plus surrounding 5 mm; planning target volume (PTV): CTV + 1mm)

Geprüfte Regime

Cavity boost radiation:
Cavity boost radiation therapy with 10 x 3 Gy for patients suffering from complete resected cerebral metastases

Quelle: ClinicalTrials.gov

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