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

NCT02887651 | Unknown

• 1 other identifier: 5405
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Metastases; Surgery

Keywords

cerebrale metastases; radiotherapy; surgery; complete surgical resection; resection; cavity boost radiation therapy; observation

Outcome Measures

Primary Outcomes (1)

• Local tumor control of resected metastases at 6 month

  Primary outcome measure is the local tumor control of resected metastases after local cavity boost radiation therapy or observation at 6 month

  6 month

Secondary Outcomes (9)

• Local tumor control of resected metastases at 12 and 18 month

  12, 18 month

• Distant tumor control of resected metastases at 6, 12 and 18 month

  6, 12 and 18 month

• Incidence of leptomeningeal carcinosis

  6, 12 and 18 month

• Eortc qlq bn20 questionaire

  3, 6, 9 12, 15, 18 month

• Eortc qlq c30 questionaire

  3, 6, 9, 12, 15, 18 month

Study Arms (2)

observation

NO INTERVENTION

patients in the observation arm receive no adjuvant local radiation therapy after complete surgical resection of a cerebral metastasis

cavity boost radiation therapy

ACTIVE COMPARATOR

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)

Radiation: Cavity boost radiation

Interventions

Cavity boost radiation RADIATION

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

cavity boost radiation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically confirmed metastasis of carcinoma (except small cell carcinoma) or malignant melanoma
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

Heinrich-Heine-University

Düsseldorf, North Rhine-Westphalia, 40225, Germany

RECRUITING

Study Officials

• Michael Sabel, Prof. Dr.

  Department of Neurosurgery

  PRINCIPAL INVESTIGATOR

• Wilfried Budach, Prof. Dr.

  department of radiation oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcel A. Kamp, MD

CONTACT

0049 - 211 - 81 - 07461; marcelalexander.kamp@med.uni-duesseldorf.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: September 2, 2016
• Study Start: November 14, 2016
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: March 22, 2022

Record last verified: 2022-03

Locations

DE (1)