CTRI/2018/02/011808
Active, not recruiting
Phase 2
The assessment of potential benefits of molecular analysis and in vitro chemo response directed at opening treatment options for relapsed and refractory metastatic solid organ tumors. - RESILIeNT (The assessment of potential benefits of molecular analysis directed at opening treatment options for RElapsed and refractory metaStatIc SoLId OrgaN Tumors.)
Datar Cancer Genetics Limited0 sites209 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Datar Cancer Genetics Limited
- Enrollment
- 209
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Age â?? 18 to 70 years (male or female);
- •2\.Cancer of any solid organ, Sarcomas, Melanomas
- •3\.Should have ECOG score of maximum 2;
- •4\.Patient should have progressed on at least 3 SOC lines, if any, of therapy and have no further SOC option/ option is beyond financial reach (such as immunotherapy/ targeted therapy etc.). Three SOC lines would include surgery / RT / Cytotoxic therapy / targeted therapy;
- •5\.Patient should be willing and fit for fresh tissue biopsy for obtaining live tumor cells / tapping of ascetic fluid / pleural fluid/ CSF etc. as the case may be;
- •6\.The last failed SOC therapy should have resulted in a Progression Free Survival of \<90 days;
- •7\.Patient should be able and willing to undertake treatment as may be advised after the analysis by DCGL with good compliance history in the past;
- •8\.Patient should be willing and ready for baseline PET Scan and/or CT and/or USG and/or MRI and follow\-up scans (usually the first follow\-up scan is after 30 days followed by further scans at 75 days and 120 days);
- •9\.Patient is willing and can tolerate cytotoxic and targeted therapy (labelled / off\-label / repurposed / natural tumor inhibiting supplements);
- •10\.Female patient is not pregnant / lactating;
Exclusion Criteria
- •1\. Lymphomas, Leukemias, Myelomas.
- •2\. Life threatening co\-morbidities such as HIV, HPV, HBV, HCV, Tuberculosis, CHF, Impaired Hepatic or Renal Function or any psychological deficits etc.
- •3\. Not fulfilling inclusion criteria
Outcomes
Primary Outcomes
Not specified
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