Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT02058056
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02058056
Study Brief:
Protocol Section:
NCT02058056