Not provided
Not provided
Not provided
Not provided
Not provided
Lack of enrollment
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The treatment of cervical cancer with chemotherapy and radiation will make women post menopausal (no estrogen from the ovaries), if a woman is not already in menopause. Estrogen plays a key role in maintaining bone health. Therefore, these women are at higher risk of getting osteoporosis (decrease minerals in the bone) and bone fractures. The overall purpose of this research is to look at the effects of zoledronic acid (Zometa) on preventing bone loss. Studies have also shown that zoledronic acid may prevent metastasis to the bone which can occur in women with cervical cancer. Zometa is investigational (not approved by the Food and Drug Administration (FDA)) in this study to prevent metastasis to the bone in women with cervical cancer. Therefore, the goal of this study is to also look at the effects of zoledronic acid (Zometa) on circulating tumor cells in the bone marrow and blood. This study is being done to find a way to prevent bone loss and metastasis to the bone in women undergoing chemotherapy and radiation for cervical cancer. An additional component of the study is to assess the importance of stress on immune markers in blood during standard treatment.
OBJECTIVES
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (No Zometa) | No Intervention | Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care. | |
| Arm 2 (Zometa) | Experimental | Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronic acid | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Circulating Tumor Cells (CTCs) | At time of diagnosis, 3 months after completion of treatment, and 9 months after completion of treatment | |
| Incidence of Disseminated Tumor Cells in Bone Marrow | At time of diagnosis, 3 months after completion of treatment, and 9 months after completion of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bone Mineral Density | At the time of diagnosis and 9 months after completion of treatment | |
| Change in Biochemical Markers of Bone Turnover | At the time of diagnosis and 9 months after completion of treatment |
Not provided
Inclusion Criteria:
Histologically proven squamous, adenosquamous or adenocarcinoma International Federation of Gynecology and Obstetrics (FIGO) Stage IB-IVA of the uterine cervix undergoing initial radiation and cisplatin based chemotherapy for primary treatment.
Gynecologic Oncology Group performance status of 0, 1, or 2.
Patients with ureteral obstruction must undergo stent placement or nephrostomy tube placement prior to study entry.
Age >= 18 years.
Patients must have signed informed consent.
Patients must have adequate:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Perry Grigsby, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | St Louis | Missouri | 63110 | United States |
Not provided
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
Not provided
Not provided
The study opened to participant enrollment on 08/12/2009 and closed to participant enrollment on 08/31/2010.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 (No Zometa) | Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care. |
| FG001 | Arm 2 (Zometa) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| If Depressed and Anxious Moods Are Associated With Greater Impairment of Adaptive Immunity and Higher Levels of Angiogenesis in Peripheral Blood | At diagnosis, 6 months after completion of treatment, and 9 months after completion of treatment |
| Relationship of SUVmax and Metabolic Heterogeneity in the Primary Tumor and Evidence of Persistent/Recurrent Disease | 3 months after completion of treatment and 9 months after completion of treatment |
Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies. Zoledronic acid |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 (No Zometa) | Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care. |
| BG001 | Arm 2 (Zometa) | Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies. Zoledronic acid |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Number | participants |
| |||||||||||||||||||||||
| Gender | Number | participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Circulating Tumor Cells (CTCs) | This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm. | Posted | At time of diagnosis, 3 months after completion of treatment, and 9 months after completion of treatment |
|
| |||||||||||||||||||||||
| Primary | Incidence of Disseminated Tumor Cells in Bone Marrow | This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm. | Posted | At time of diagnosis, 3 months after completion of treatment, and 9 months after completion of treatment |
|
| |||||||||||||||||||||||
| Secondary | Change in Bone Mineral Density | This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm. | Posted | At the time of diagnosis and 9 months after completion of treatment |
|
| |||||||||||||||||||||||
| Secondary | Change in Biochemical Markers of Bone Turnover | This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm. | Posted | At the time of diagnosis and 9 months after completion of treatment |
|
| |||||||||||||||||||||||
| Secondary | If Depressed and Anxious Moods Are Associated With Greater Impairment of Adaptive Immunity and Higher Levels of Angiogenesis in Peripheral Blood | This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm. | Posted | At diagnosis, 6 months after completion of treatment, and 9 months after completion of treatment |
|
| |||||||||||||||||||||||
| Secondary | Relationship of SUVmax and Metabolic Heterogeneity in the Primary Tumor and Evidence of Persistent/Recurrent Disease | This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm. | Posted | 3 months after completion of treatment and 9 months after completion of treatment |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 (No Zometa) | Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care. | 0 | 3 | 3 | 3 | ||
| EG001 | Arm 2 (Zometa) | Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies. | 0 | 0 | 0 | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hemoglobin | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Leukocytes (WBC) | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pelvis pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Perry Grigsby, M.D. | Washington University School of Medicine | 314-362-8502 | pgrigsby@radonc.wustl.edu |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| >=65 years |
|
| Title | Measurements |
|---|---|
|
|