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To determine if treatment with cisplatin and radiation followed by carbo and taxol reduces the rate of recurrence when compared to sandwich therapy.
To determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of recurrence (increases recurrence-free survival) when compared to sandwich therapy (control arm).
To determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of death (increases survival) when compared to sandwich therapy (control arm).
To compare the regimens with respect to tolerability and acute and late adverse effects of therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen I | Experimental | Cisplatin 50 mg/m2 IV Days 1 and 29 plus Volume-directed radiation therapy followed by Carboplatin AUC 5 or 6 plus Paclitaxel 175 mg/m2 q 21 days for 4 cycles |
|
| Regimen II | Active Comparator | Carboplatin AUC 6 plus Paclitaxel 175 mg/m2 q 21 days for 3 cycles followed by Volume-directed radiation therapy followed by Carboplatin AUC 5 or 6 plus Paclitaxel 175 mg/m2 q 21 days for 3 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-free survival (RFS) | RFS will be assessed by radiology tests, patient's clinical symptoms or physical exam. | From study entry until disease recurrence, death, or date of last contact, assessed up to 8 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | OS assessed by the contact with patient in person or by telephone | from study entry to death or date of last contact, assessed up to 8 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute and adverse effects as graded by the NCI Common Toxicity Criteria for Adverse Events version (CTCAE) version 4.0 | From study entry through completion of study treatment, assessed for 1 year. |
Inclusion Criteria:
WBC ≥ 3000/mcl Absolute neutrophil count (ANC) ≥ 1500/mcl Platelet count ≥ 100,000/mcl SGOT, SGPT, and alkaline phosphatase ≤ 2.5 X upper limit of normal (ULN) Bilirubin ≤ 1.5 X ULN Creatinine ≤ institutional ULN
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joyce N Barlin, MD | Women's Cancer Care Associates, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | United States | ||
| Munson Health Care |
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| Carboplatin |
| Drug |
Given IV |
|
|
| Paclitaxel | Drug | Given IV |
|
|
| Radiation Therapy | Radiation | Undergo Radiation Therapy |
|
|
| Traverse City |
| Michigan |
| 49684 |
| United States |
| Atlantic Health | Morristown | New Jersey | 07960 | United States |
| Women's Cancer Care Associates, LLC | Albany | New York | 12208 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Gunderson Lutheran Medical Foundation | La Crosse | Wisconsin | 54601 | United States |
| CHUM Hopital Notre-Dame | Montreal | Quebec | H2L4M1 | Canada |
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |
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