CTRI/2017/05/008500Other未知
A PROSPECTIVE, MULTICENTER, OBSERVATIONAL STUDY EXAMINING THE CLINICAL UTILITY OF CANSCRIPT IN ROUTINE CLINICAL PRACTICE - ANCERS-1
Dr D C Doval0 sites649 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Other
- Sponsor
- Enrollment
- 649
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
Inclusion Criteria
- •1.Histologically- or cytologically-confirmed:
- •Locally advanced /metastatic/recurrent HNSCC;
- •Locally advanced / metastatic/recurrent Stage 3b or 4 NSCLC after failure of appropriate 1st line therapy
- •oPatients with known EGFR or ALK or ROS mutations must have received previous appropriate tyrosine kinase inhibitor therapy;
- •Locally advanced /metastatic/recurrent TNBC;
- •Locally advanced /metastatic/recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma after failure of 1st line platinum-based chemotherapy
- •oRecurrent or persistent stage 3 or 4 disease requiring relapse histologic documentation;
- •Stage 4 metastatic/recurrent CRC
- •2.The patientâ??s tumour (primary or metastatic sites) must be amenable to a fresh tumour biopsy sampling using surgical/excision biopsy or core biopsy, so that CANscript can be performed
- •3.The patient must have disease that is measurable by standard imaging techniques, as per the RECIST 1.1 (For patients with prior radiation therapy, measurable lesions must be outside of any prior radiation field[s], unless disease progression has been documented at that disease site subsequent to radiation)
- •4.Male or female patient who is >=18 years
- •5.ECOG performance status of <=2
- •6.Patient willing to provide written informed consent prior to initiation of any study-specific procedures
Exclusion Criteria
- •Note: Based onpatientâ??s clinical and medical history andno additional diagnostic test / investigations needs to be performed
- •1. The patient has persistent clinically significant toxicities (Grade >=2) from previous anticancer therapy (excluding chronic Grade 2 chemotherapy-related neuropathy which is permitted, and excluding Grade 2-3 laboratory abnormalities if they are not associated with symptoms, are not considered clinically significant by the site-investigator, and can be managed with available medical therapies).
- •2. The patient has received treatment with chemotherapy, external-beam radiation, or other systemic anticancer therapy within 14 days prior to study entry (42 days for prior nitrosourea or mitomycin-C)(Patients could have received supportive care therapeutics as appropriate).
- •3. The patient has an additional active malignancy that may confound the assessment of the study endpoints. Patients with a past cancer history (active malignancy within 2 years prior to study entry) with substantial potential for recurrence must be discussed with the site-investigatorbefore study entry. Patients with the following concomitant neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ (including transitional cell carcinoma, cervical intraepithelial neoplasia), organ-confined prostate cancer with no evidence of progressive disease.
- •4. The patient has clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association Class 3 or 4 congestive heart failure, uncontrolled angina, history of myocardial infarction, unstable angina or stroke within 6 months prior to study entry, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication).
- •5. The patient has uncontrolled, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, pulmonary hypertension) that in the opinion of the site-investigator would put the patient at significant risk for pulmonary complications during the study.
- •6. The patient has known active or suspected brain or leptomeningeal metastases(central nervous system [CNS] imaging is not required prior to study entry unless there is a clinical suspicion of CNS involvement). Patients with stable, treated brain metastases are eligible provided there is no evidence of CNS disease growth on imaging for at least 6 weeks following radiation therapy or other loco-regional ablative therapy to the CNS.
- •7. The patient is receiving immunosuppressive therapy for prophylaxis following a prior organ transplant (solid organ or allogeneic stem cell). Corticosteroid therapy is permitted.
- •8. The patient has uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness/social situations that would limit compliance with study requirements and/or treatment with standard dose-schedules of reasonable therapeutic regimens for the disease.
- •9. Female patient having known positive status for pregnancy or breast feeding.
- •10. The patient has known positive status for human immunodeficiency virus active or chronic Hepatitis B or Hepatitis C.
- •11. Participation in another research study within a period of 30 days prior to the date of enrollment.
Investigators
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