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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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.

Detailed Summary:

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 l
Sponsor: Heinrich-Heine University, Duesseldorf

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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
  • 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
  • Eortc qlq bn20 questionaire [ Time Frame: 6 weeks, 3, 6, 9 12, 15, 18, 21, 24 month ]
    Secondary outcome measure is the patients quality of life at 6 weeks, 3, 6, 9 12, 15, 18, 21 and 24 month as assessed by the Eortc qlq bn20 questionaire
  • Eortc qlq c30 questionaire [ Time Frame: 6 weeks, 3, 6, 9 12, 15, 18, 21, 24 month ]
    Secondary outcome measure is the patients quality of life at 6 weeks, 3, 6, 9 12, 15, 18, 21 and 24 month as assessed by the Eortc qlq c30 questionaire
  • Mini-Mental State Examination (MMSE) [ Time Frame: 6 weeks, 3, 6, 9 12, 15, 18, 21, 24 month ]
    Secondary outcome measure is the patients neurocognitive functioning at 6 weeks, 3, 6, 9 12, 15, 18, 21 and 24 month as assessed by the MMSE,
  • Hopkins Verbal Learning Test (HVLT) [ Time Frame: 6 weeks, 3, 6, 9 12, 15, 18, 21, 24 month ]
    Secondary outcome measure is the patients neurocognitive functioning at 6 weeks, 3, 6, 9 12, 15, 18, 21 and 24 month as assessed by the Hopkins Verbal Learning Test (HVLT),
  • Controlled Oral Word Association (COWA) [ Time Frame: 6 weeks, 3, 6, 9 12, 15, 18, 21, 24 month ]
    Secondary outcome measure is the patients neurocognitive functioning at 6 weeks, 3, 6, 9 12, 15, 18, 21 and 24 month as assessed by the Controlled Oral Word Association (COWA)
  • Test and Trail-Making Test (TMT) A & B [ Time Frame: 6 weeks, 3, 6, 9 12, 15, 18, 21, 24 month ]
    Secondary outcome measure is the patients neurocognitive functioning at 6 weeks, 3, 6, 9 12, 15, 18, 21 and 24 month as assessed by the Test and Trail-Making Test (TMT) A & B


Original Secondary Outcome: Same as current

Information By: Heinrich-Heine University, Duesseldorf

Dates:
Date Received: July 14, 2016
Date Started: October 2016
Date Completion: May 2020
Last Updated: August 29, 2016
Last Verified: August 2016