A Phase 2 interventional study of Docetaxel and cisplatin and Docetaxel and cisplatin Plus Hypofractionated Radiotherapy in Non-small Cell Lung Cancer, sponsored by University of Chicago. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-06.
Sponsored by University of Chicago · Phase 2, Interventional, and Treatment
Primary goal of the study is to assess the overall survival of the addition of hypofractionated image guided radiotherapy concurrently with Docetaxel and cisplatin. Survival will be assessed at 1 year from the date of study enrollment to date of death.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 11 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.
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Inclusion Criteria:
Patients with AJCC stage IV cancer with distant metastases and without malignant pleural or pericardial effusion at diagnosis and before start of study
Exclusion Criteria:
Chemotherapy only
Drug: Docetaxel and cisplatin
Chemotherapy and hypofractionated image guided radiotherapy
Radiation: Docetaxel and cisplatin Plus Hypofractionated Radiotherapy
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 IV repeated every 21 days for 2 additional cycles. For patients randomized to group 1, the chemotherapy is identical to that administered for the first 2 cycles
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 IV for 2 cycles along with hypofractionated radiotherapy to all known sites of disease
1-Year Overall Survival
Overall survival is assessed at 1 year from the date of study enrollment to date of death.
Time frame: Baseline to death from any cause, 1 year
Overall PFS and CT Rate
Overall PFS and CT rate is assessed response with PET and CT. Toxicity of addition of high dose focused RT to systemic therapy.Late (\>90 day) radiotherapy toxicity will be assessed with RTOG/EORTC late RT toxicity guidelines
Time frame: >90 days
Funding was withdrawn before conclusions were reached so the study was terminated.
| Milestone | Chemo Only | Chemo and Radiation |
|---|---|---|
| Started | 7 | 4 |
| Completed | 0 | 0 |
| Not completed | 7 | 4 |
| Withdrew: Study termination | 7 | 4 |
Overall survival is assessed at 1 year from the date of study enrollment to date of death.
No measurements were reported for this outcome.
Overall PFS and CT rate is assessed response with PET and CT. Toxicity of addition of high dose focused RT to systemic therapy.Late (\>90 day) radiotherapy toxicity will be assessed with RTOG/EORTC late RT toxicity guidelines
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Chemo Only | — | — | — |
| Chemo and Radiation | — | — | — |
| Age, Categorical(Participants) | Chemo Only | Chemo and Radiation | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 0 | 3 |
| >=65 years | 4 | 4 | 8 |
| Age Continuous(years) | Chemo Only | Chemo and Radiation | Total |
|---|---|---|---|
| Mean | 66.4 ± 10.6 | 74 ± 3.2 | 69.1 ± 9.2 |
| Sex: Female, Male(Participants) | Chemo Only | Chemo and Radiation | Total |
|---|---|---|---|
| Female | 5 | 2 | 7 |
| Male | 2 | 2 | 4 |
This study is terminated, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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