EXtendedAnalysis for Cancer Treatment
- Conditions
- Malignant Solid Tumor
- Interventions
- Other: individual therapy
- Registration Number
- NCT02999750
- Lead Sponsor
- Medical University of Vienna
- Brief Summary
The purpose of this study is to prospectively validate treatment benefit of an individualized treatment concept based on molecular profiling (MP) from paraffin-embedded tumor tissue sections obtained before the start of treatment (real time biopsy).
- Detailed Description
The treatment concept will be considered to be of clinical benefit for the individual patient if a progression-free survival (PFS) ratio (PFS on MP-based therapy / best PFS achieved by prior therapy) will be \> 1.0 thus generating a patient cohort with this very property. Thereby, the null hypothesis (that ≤ 40 % of this patient population would have a PFS ratio of \> 1.0) will be evaluated with each patient being his own control. For tumor types with high numbers of patients per cohort, the overall response rate (ORR) will be evaluated.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 55
Consenting patients of >19 years with advanced cancer fulfilling the criteria of having:
- an advanced malignancy with metastatic spread refractory to conventional treatment
- a life expectancy of >4 months,
- the possibility to access and biopsy tumour material within 4 weeks before onset of individualized treatment,
- a malignancy amenable to further treatment options with either cytotoxic drugs, tyrosine kinase inhibitors, monoclonal antibodies or related molecules with anti-proliferative potential to cancer cells, as assessed by the ex vivo analysis and a likelihood of treatment response according to the mathematical model (all outlined in detail above),
- agreed to participate by their signature on an informed consent form are eligible.
- Presence of further treatment options, as defined by NCCN guidelines which are available in Austria representing a possible further treatment-related response by conventional therapies according to generally accepted medical evidence.
- No fresh and viable tumor material available.
- Current use of therapeutic warfarin.
- Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE v4.0) Grade 2 or higher from previous anti-cancer therapy, except alopecia.
- Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption of drugs.
- A history of known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection.
- A history of known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- History of other malignancy. Subjects who have been disease-free for 5 years or those with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
- Uncontrolled medical conditions (i.e, diabetes mellitus, hypertension, etc), psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol)
- unwillingness or inability to follow the procedures required in the protocol.
- pregnant or lactating females.
- History of alcohol or drug abuse within 6 months prior to screening.
- No informed consent available.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description individual therapy individual therapy individual therapy
- Primary Outcome Measures
Name Time Method Use of real time biopsy to establish an individual molecular profile by using next generation sequencing 2 years pathological examination (includes genetic and target expression profiling, and drug sensitivity screening) to rank treatment options and the potential correlation between treatment response and progression free survival
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
AKH Vienna
🇦🇹Vienna, Austria