Comparison of Standard of Care or Treatment on Protocol

Study Overview
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Brief Summary
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Patient will choose to either receive the standard of care according to National Comprehensive Cancer Network (NCCN) or approved guidelines for their condition or to be treated according to one arm of the protocol that they could not be enrolled on. The selection of the arm will be at physician discretion.

Detailed Description
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All patients failing to enroll in a specific therapeutic research protocol using FDA approved drugs or CTMS accepted therapies will be screened for this study. Patients will be randomized (Patient own choice) to either standard of care described in the NCCN guidelines and published as peer-reviewed phase II or III studies which show an efficacy or to one of the arms of the protocol they fail to enroll in, as determined by the treating physician.

Official Title
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Randomized Study of Patients (Patient Choice) Who Are Not Eligible for Variations of Standard of Care Protocols When Treated Either on Best Standard of Care Pathways or Per a Protocol Arm That They Failed to Enroll to

Conditions
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Stomach Cancer, Esophageal Cancer, Bladder Cancer, Skin Cancer, Lung Cancer, Uterine Cancer, Ovarian Cancer

Intervention / Treatment
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* Other: standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have a cancer requiring chemotherapy or radiotherapy Exclusion Criteria: Inability to comply with study and/or follow-up procedures Any contraindication per the FDA notice to the selected drugs Pregnant (positive pregnancy test) or lactating. No effective means of contraception (men and women) in subjects of child-bearing potential

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>Standard of Care Treatment | Other: standard of care<br>* All patients failing to enroll in a specific therapeutic research protocol using FDA approved drugs or CTMS accepted therapies will be screened for this study. Patients will be randomized (Patient own choice) to either standard of care described in the NCCN guidelines and published as peer-reviewed phase II or III studies which show an efficacy, OR to one of the arms of the protocol they failed to enroll in, as determined by the treating physician.<br>* Other names: VARIIOUS experimental therapies (based on protocol for which pt failed eligibility);|
| Experimental: Arm 2<br>Treatment Arm of a separate protocol (physician discretion) | Other: standard of care<br>* All patients failing to enroll in a specific therapeutic research protocol using FDA approved drugs or CTMS accepted therapies will be screened for this study. Patients will be randomized (Patient own choice) to either standard of care described in the NCCN guidelines and published as peer-reviewed phase II or III studies which show an efficacy, OR to one of the arms of the protocol they failed to enroll in, as determined by the treating physician.<br>* Other names: VARIIOUS experimental therapies (based on protocol for which pt failed eligibility);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of courses delivered (relative dose intensity for adjuvant studies) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | 6 months | 
| Progression- or disease-free survival (for metastatic disease) |  | 6 months | 
| Overall survival |  | 6 months | 
| Describe all adverse events of grade > 3 and Serious Adverse Events |  | 6 months | 
| Measure quality of life using a FACT G tool, before and at best response and at the end of the treatment |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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INST 0813, Standard of Care