Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT00876759 : Whole-Brain Radiotherapy (WBRT) Versus WBRT and Integrated Boost Using Helical Tomotherapy for Multiple Brain Metastases
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Histologically or cytologically confirmed extracranial primary malignancy other than
small cell lung cancer, germ cell tumor and lymphoma. Histological confirmation may
have been from the primary tumor site, from another metastatic site, or from the
metastatic brain lesion(s)

- 4-10 brain metastases, which are radiologically proven by MRI scan. The size of each
metastasis must be between 3 mm and 4.0 cm in the largest diameter.
Contrast-enhancements on MRI which are smaller than 3 mm in diameter are not
considered. The total volume of the lesions must be smaller than 35 ml and the volume
of perilesional normal brain receiving more than 4 Gy per fraction must be smaller
than 40 ml. An evaluation of the latter criterion is strongly recommended for total
lesions volume > 20 ml prior to randomization of the patient according to figure 1.
OR

- 2-3 brain metastases, which are radiologically proven by MRI scan. The size of each
metastasis must be between 3 mm and 4.0 cm in the largest diameter.
Contrast-enhancements on MRI which are smaller than 3 mm in diameter are not
considered. The patient should not be considered as a good candidate for stereotactic
radiosurgery +/- whole brain radiotherapy.

- Each lesion has a distance of its margin to the chiasma opticum or the optic nerves
of > 5 mm.

- Male or female, Age 18 years or older

- Laboratory requirements: hematological status must be documented.

- Platelets >30 x 109/l. If platelets are below 30 x 109/l then correction by
transfusion is indicated before entry into the study according to institutional
guidelines.

- Hemoglobin > 8 g/dl. If anemia is present to the extent that the hemoglobin is less
than 8 g/dl then correction by transfusion and/or erythropoietin is indicated before
entry into the study according to institutional guidelines.

- Before patient registration, written informed consent must be given according to
ICH/GCP and national regulations.

Exclusion Criteria:

- Lesions located in the medulla oblongata or in the brainstem.

- Leptomeningeal metastases or meningosis carcinomatosa. If meningosis carcinomatosa is
suspected on MRI, the presence of tumor cells in the liquor cerebrospinalis must be
excluded prior study entry.

- Chemotherapy within 1 week prior to study treatment

- Need for systemic chemotherapy to control primary disease or extracranial metastases
within 3 weeks after study treatment (assessed before randomization)

- Prior treatment for brain metastases other than chemotherapy or resection of brain
metastases (with 2-10 measurable lesions remaining), prior cranial radiotherapy

- Severe coagulopathy

- Medical illnesses or psychiatric impairments which would prevent completion of
protocol therapy

- Female patients who are pregnant at the time of entering the study. Women must agree
to a beta-HCG pregnancy test if the possibility of pregnancy is believed to exist.
Women and men of child bearing potential who are admitted to the trial will be
advised that the treatment received may be teratogenic and are advised to take
adequate measures to prevent conception.

- Participation in other clinical trials within 4 weeks prior registration.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT00876759      |      Link to official Clinicaltrials.gov listing
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