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Early Hippocampal Avoidance Prophylactic Cranial Irradiation in Patients With LD SCLC

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ClinicalTrials.gov Identifier: NCT02058056
Recruitment Status : Completed
First Posted : February 7, 2014
Last Update Posted : January 29, 2020
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

Brief Summary:
The main objective of this trial is to assess NCF after early HA-PCI concomitant to the second cycle of CHT and to tRT for patients with LD SCLC.

Condition or disease Intervention/treatment Phase
Small-Cell Lung Cancer Radiation: Irradiation: HA-PCI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Prophylactic Cranial Irradiation With Hippocampal Avoidance in Patients With Limited Disease Small-cell Lung Cancer. A Multicenter Phase II Trial
Actual Study Start Date : July 11, 2014
Actual Primary Completion Date : June 7, 2018
Actual Study Completion Date : December 3, 2018

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Arm Intervention/treatment
Experimental: Experimental: HA-PCI treatment
Irradiation HA-PCI concomitant to the second cycle of CHT and to tRT for patients with LD SCLC
Radiation: Irradiation: HA-PCI
25 Gy in 10 daily factions, five times a week

Primary Outcome Measures :
  1. Neurocognitive functioning (NCF) [ Time Frame: at 6 months ]
    NCF at 6 months after end of HA-PCI treatment measured by Hopkins Verbal Learning Test Revised (HVLT-R), Controlled Oral Word Association (COWAT) and Trail Making Test Part A and B (TMT A/B). A neurocognitive decline is defined as a decrease of one standard error of measurement (SEM) in any of the four NCF tests.

Secondary Outcome Measures :
  1. Brain metastasis free survival (BMFS) [ Time Frame: At 6 months and 12 months. ]
  2. Adverse events according to NCI CTCAE version 4.0 [ Time Frame: Until 1 year after the end of HA-PCI treatment. ]
  3. Neurotoxicity [ Time Frame: Until 1 year after HA-PCI treatment. ]
    Neurotoxicity according to NCI CTCAE version 4.0

  4. Individual tests for each cognitive domain (memory, verbal fluency, visual motor speed, executive function). [ Time Frame: At 6 weeks, 6 and 12 months after the end of HA-PCI treatment. ]
  5. Overall survival (OS) [ Time Frame: From time of registration (expected average of 20 months) ]
  6. Quality of Life (QoL) measured by functional assessment of cancer therapy-brain (FACT-Br) and general health questionnaire (GHQ-12) [ Time Frame: At 6 weeks, 6 and 12 months after the end of HA-PCI treatment. ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02058056

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Universitätsspital Basel
Basel, Switzerland, CH-4031
Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli
Bellinzona, Switzerland, 6500
Inselspital Bern
Bern, Switzerland, CH-3010
Kantonsspital Graubuenden
Chur, Switzerland, 7000
Hopital Fribourgeois
Fribourg, Switzerland, 1708
Hopitaux Universitaires de Geneve
Genève 14, Switzerland, 1211
Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007
Kantonsspital Winterthur
Winterthur, Switzerland, CH-8400
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
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Study Chair: Francesca Caparrotti, MD Hôpitaux Universitaires de Genève, Genève
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Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT02058056    
Other Study ID Numbers: SAKK 15/12
First Posted: February 7, 2014    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Swiss Group for Clinical Cancer Research:
Early prophylactic
cranial irradiation
hippocampal avoidance
limited disease small-cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms