Clinical Trial Details
Braintumor Website

[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.]

NCT02058056 : Early Hippocampal Avoidance Prophylactic Cranial Irradiation in Patients With LD SCLC
PhasePhase 2
AgesMin: 18 Years Max: 75 Years
Eligibility
Inclusion Criteria:

- Newly diagnosed cytologically or histologically confirmed diagnosis of SCLC within 6
weeks before registration.

- Proven LD SCLC (CT thorax, abdomen, and bone scan (or PET/CT only) and brain MRI
within 6 weeks before registration) according to the TNM classification version 7
that can be encompassed within a radical radiation port

- Only patients assessed by an interdisciplinary tumor board should be declared
eligible taking into account eligibility for curative tRT and CHT according to NCCN
Guidelines version 2.2014

- Karnofsky Index ? 60%

- Age at registration 18 to 75 years

- Normal bone marrow function: neutrophils ? 1.5 x 109/L, platelets ? 100 x 109/L

- Calculated creatinine clearance ? 60 mL/min is required if chemotherapy with
cisplatin is scheduled. If cisplatin has to be replaced by carboplatin a creatinine
clearance ? 50 mL/min is required

- Normal liver function: bilirubin ? 1 x ULN, AST and ALT ?1.5 x ULN

- Fluency in either German, French or Italian

- Women are not breastfeeding. Women with child-bearing potential are using effective
contraception, are not pregnant and agree not to become pregnant during participation
in the trial and during the 6 months thereafter. A negative pregnancy test before
inclusion (within 7 days) into the trial is required for all women with child-bearing
potential. Men agree not to father a child during participation in the trial and
during 6 months thereafter.

- Baseline QoL questionnaires FACT-Br and GHQ-12 have been completed within 14 days
before registration

- Baseline NCF assessments have been completed within 14 days before registration:

- HVLT-R

- COWAT

- TMT A

- TMT B

- Patient must give written informed consent before registration

Exclusion Criteria:

- Previous malignancy within 5 years with the exception of adequately treated cervical
carcinoma in situ or localized non-melanoma skin cancer

- History of CNS metastases

- Prior brain RT

- History of RT to the thorax

- Psychiatric disorder precluding understanding of information on trial related topics,
giving informed consent, filling out QoL forms, participating in assessing NCF
testing or interfering with compliance for oral drug intake.

- Concurrent treatment with other experimental drugs or other anti-cancer therapy,
treatment in a clinical trial within 30 days prior to trial entry.

- Any serious underlying medical condition (at the judgment of the investigator) which
could impair the ability of the patient to participate in the trial (e.g. active
autoimmune disease, uncontrolled diabetes).

- Any concomitant drugs contraindicated for use with the treatment drugs according to
the approved product information.

- History of cerebrovascular disease or epilepsy requiring continuous treatment

- Symptomatic cardiac disease or a history of myocardial infarction within the previous
3 months

- Any psychological, familial or sociological/geographical conditions potentially
hampering compliance with the study protocol and follow-up schedule

- Legal incapacity or limited legal capacity
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02058056      |      Link to official Clinicaltrials.gov listing
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