Bladder Cancer, Esophageal Cancer, Lung Cancer, Ovarian Cancer, Skin Cancer, Stomach Cancer, Uterine Cancer
Conditions
Keywords
INST 0813, Standard of Care
Brief summary
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
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.
Interventions
OTHERstandard of care
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.
Sponsors
New Mexico Cancer Research Alliance
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of courses delivered (relative dose intensity for adjuvant studies) | 6 months |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed