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Didn't meet accrual goal, change in standard of care.
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| Name | Class |
|---|---|
| East Carolina University | OTHER |
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It is the hypothesis of this protocol that a subset of NSCLC patients with stage IVa disease can benefit from curative therapy and extends beyond the very limited subset of oligometastatic patients that have already been studied.
In this study, patiently will be aggressively treated with 4 cycles of full dose platinum-based chemotherapy with concurrent radiation therapy to the primary tumor and identified mediastinal lymph nodal metastatic drainage. Local curative radiation will then target the oligometastatic tumor sites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm study | Other | Induction chemotherapy and concurrent radiation to primary tumor Cycle 1: irinotecan 65mg/m2 and cisplatin 30 mg/m2 on Day 1 and 8 Q 21 days Cycles 2-4: irinotecan 65 mg/m2, and cisplatin 30 mg/m2 Day 1 and 8 Q 21 days PLUS radiation therapy 66 Gy/7weeks/33 daily fractions Consolidation Radiation: therapy to metastatic sites At least 60 Gy total (taking into account a possible 3 Gy x 4 pre-treatment or equivalent) to all metastatic sites. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Induction chemotherapy and concurrent radiation | Other | Cycle 1: irinotecan 65mg/m2 and cisplatin 30 mg/m2 on Day 1 and 8 Q 21 days Cycles 2-4: irinotecan 65 mg/m2, and cisplatin 30 mg/m2 Day 1 and 8 Q 21 days PLUS radiation therapy 66 Gy/7weeks/33 daily fractions |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Measure time of survival from enrollment to death from any cause, assessed up to 100 months. | Anticipated medial survival time is 8 - 10 months, however, all participants will be followed until death, assessed up to 100 months. |
| Measure | Description | Time Frame |
|---|---|---|
| New metastatic disease | Measure of time from patient entry to time of new disease or progression of disease or date of death from any cause, whichever came first, assessed up to 100 months. | Anticipated time to progression is unknown, however, all patients will be followed for survival, up to 100 months. |
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Inclusion Criteria:
Metastatic disease; either biopsy proven or with strong radiographic evidence suggesting its existence.
As determined by CT, MRI or PET no more than five distinct metastatic sites. All metastatic disease must be anatomically located in such a way as to permit a reasonable attempt at permanent ablation. Ablative measures may include surgery, stereotactic radiosurgery, and external beam therapy. Patients who meet the minimal metastatic disease requirement and who would otherwise have been staged II, IIIA or IIIB.
A medical history, physical exam, and Zubrod performance status within 3 weeks prior to study entry.
Complete blodd count (CBC) with differential and platelet count, and laboratory profile must be completed within 3 weeks prior to study entry.
FEV1, CT scan of the chest or whole body PET (preferred), and a CT scan or MRI (preferred) of the brain within 4 weeks prior to study entry.
For women of childbearing potential, a serum or urine pregnancy test within a week prior to the start of protocol treatment.
Medical Oncology and Radiation Oncology consultation and approval.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Walker, MD, PhD | Brody School of Medicine ar East Carolina University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leo W. Jenkins Cancer Center | Greenville | North Carolina | 27834 | United States |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| ID | Term |
|---|---|
| D060828 | Induction Chemotherapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D012074 | Remission Induction |
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| Consolidation: Radiation therapy to metastatic sites | Other | At least 60 Gy total (taking into account a possible 3 Gy x 4 pre-treatment or equivalent) to all metastatic sites. For brain, 2.5 Gy x 14 to whole brain to follow stereotactic radiosurgery (SRS). |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |