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The purpose of this study is to determine the maximum tolerated dose of integrated boost radiation therapy when given with concurrent chemotherapy (cisplatin).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Boost Radiation: Dose Level 1 | Experimental | 2.4 Gy X 25 fractions = 60 Gy |
|
| Boost Radiation: Dose level 2 | Experimental | 2.6 Gy X 25 fractions = 65 Gy |
|
| Boost Radiation: Dose level 3 | Experimental | 2.8 Gy x 25 fractions = 70 Gy |
|
| Experimental: Boost Radiation Dose Level 0 | Experimental | If the 2 dose limiting toxicities are documented at dose level 1, therapy will be de-escalated to Dose level 0 defined below. Dose level 0: 2.2 Gy X 25 fractions = 55 Gy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boost radiation | Radiation | Many studies have utilized a sequential boost to deliver a total dose of 55 - 60 Gy to the pelvic sidewall (covering the lower pelvic lymph nodes), including 8-10 Gy that is usually delivered with brachytherapy (1-3). This study treatment plan will escalate the dose to pelvic and para-aortic nodal disease from 60 Gy in 2.4 Gy per fraction to 70Gy in 2.8 Gy per fraction in 3 dose cohorts, using an integrated boost technique utilizing the same number of fractions for all cohorts (25 fractions) while the elective volumes are held constant at 45Gy |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose of Integrated Boost Radiation Therapy, Administered With IMRT Technique With Concurrent Chemotherapy (Cisplatin). | Concurrent radiation therapy and chemotherapy is the standard of care for node positive cervical cancer. While there are several acceptable means to boost the disease in the low pelvis (i.e. brachytherapy, IMRT, or external beam), there is limited research into boosting gross disease in the pelvis or para-aortic region. This protocol is designed to determine the maximum tolerated dose of treating tumor bearing regions within the abdomen and pelvis, using an integrated boost technique and concurrent chemotherapy. | During RT to 6 weeks post RT |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Local-regional Control With Integrated Boost Radiation Therapy (TTLR) | Local-regional control is defined as local control without any nodal recurrence. | 3 years following treatment |
| Time to Distant Recurrence (TTDR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Junzo Chino, MD | Duke Cancer Center/Radiation Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiation Oncology, DUMC | Durham | North Carolina | 27710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Boost Radiation: Dose Level 1 | 2.4 Gy X 25 fractions = 60 Gy |
| FG001 | Boost Radiation: Dose Level 2 | 2.6 Gy X 25 fractions = 65 Gy |
| FG002 | Boost Radiation: Dose Level 3 | 2.8 Gy x 25 fractions = 70 Gy |
| FG003 | Boost Radiation Dose Level 0 | If the 2 dose limiting toxicities are documented at dose level 1, therapy will be de-escalated to Dose level 0 defined below. Dose level 0: 2.2 Gy X 25 fractions = 55 Gy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No subjects were reduced to Boost Radiation Level 0
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| ID | Title | Description |
|---|---|---|
| BG000 | Boost Radiation: Dose Level 1 | 2.4 Gy X 25 fractions = 60 Gy |
| BG001 | Boost Radiation: Dose Level 2 | 2.6 Gy X 25 fractions = 65 Gy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Maximum Tolerated Dose of Integrated Boost Radiation Therapy, Administered With IMRT Technique With Concurrent Chemotherapy (Cisplatin). | Concurrent radiation therapy and chemotherapy is the standard of care for node positive cervical cancer. While there are several acceptable means to boost the disease in the low pelvis (i.e. brachytherapy, IMRT, or external beam), there is limited research into boosting gross disease in the pelvis or para-aortic region. This protocol is designed to determine the maximum tolerated dose of treating tumor bearing regions within the abdomen and pelvis, using an integrated boost technique and concurrent chemotherapy. | Posted | Number | Gray (Gy) | During RT to 6 weeks post RT |
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose Level 1 | Participants received increasing doses of Radiation at 12.4 Gy X 25 fractions = 60 Gy (N=3) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Mewshaw, MS RN | Duke University Health System | (919) 668-5211 | Jennifer.Mewshaw@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 3, 2015 | Dec 10, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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|
| 3 years after treatment |
| Disease Free Survival (DFS) | 3 years after treatment |
| Overall Survival (OS) | 3 years after treatment |
| Number of Participants With Acute Dose Limiting Toxicities (DLT) | Acute DLT will be defined based on the side effects inherent from radiation therapy for gynecologic cancers, including effects on bowel, bladder, and skin.Since integrated radiation dose escalation is unlikely to substantially affect the hematopoietic system, only non-hematologic, grade 3-4, acute toxicity will be considered the primary dose-limiting toxicity (acute DLT). Dose limiting toxicity will include any of the following during treatment or within 6 weeks of completion: Acute Grade 3-4 enteritis or proctitis, Acute Grade 3-4 bladder toxicity, Acute Grade 4 dermatologic toxicity. | 6 weeks following treatment |
| Number of Participants With Late Dose Limiting Toxicities (DLT) | Late DLTs will be defined at grade 3-4 GI or GU toxicity with onset after 6 weeks of treatment. | 3 years following treatment |
| BG002 | Boost Radiation: Dose Level 3 | 2.8 Gy x 25 fractions = 70 Gy |
| BG003 | Boost Radiation Dose Level 0 | If the 2 dose limiting toxicities are documented at dose level 1, therapy will be de-escalated to Dose level 0 defined below. Dose level 0: 2.2 Gy X 25 fractions = 55 Gy |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Time to Local-regional Control With Integrated Boost Radiation Therapy (TTLR) | Local-regional control is defined as local control without any nodal recurrence. | Posted | Mean | Standard Deviation | years | 3 years following treatment |
|
|
|
| Secondary | Time to Distant Recurrence (TTDR) | Posted | Mean | Standard Deviation | years | 3 years after treatment |
|
|
|
| Secondary | Disease Free Survival (DFS) | Posted | Mean | Standard Deviation | years | 3 years after treatment |
|
|
|
| Secondary | Overall Survival (OS) | Posted | Mean | Standard Deviation | years | 3 years after treatment |
|
|
|
| Secondary | Number of Participants With Acute Dose Limiting Toxicities (DLT) | Acute DLT will be defined based on the side effects inherent from radiation therapy for gynecologic cancers, including effects on bowel, bladder, and skin.Since integrated radiation dose escalation is unlikely to substantially affect the hematopoietic system, only non-hematologic, grade 3-4, acute toxicity will be considered the primary dose-limiting toxicity (acute DLT). Dose limiting toxicity will include any of the following during treatment or within 6 weeks of completion: Acute Grade 3-4 enteritis or proctitis, Acute Grade 3-4 bladder toxicity, Acute Grade 4 dermatologic toxicity. | Posted | Count of Participants | Participants | 6 weeks following treatment |
|
|
|
| Secondary | Number of Participants With Late Dose Limiting Toxicities (DLT) | Late DLTs will be defined at grade 3-4 GI or GU toxicity with onset after 6 weeks of treatment. | Posted | Count of Participants | Participants | 3 years following treatment |
|
|
|
| 1 |
| 3 |
| 2 |
| 3 |
| 3 |
| 3 |
| EG001 | Dose Level 2 | 2.6 Gy X 25 fractions = 65 Gy (N=3), | 1 | 3 | 0 | 3 | 3 | 3 |
| EG002 | Dose Level 3 | 2.8 Gy x 25 fractions = 70 Gy (N=6) | 1 | 6 | 1 | 6 | 6 | 6 |
| Rectal necrosis | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Urinary fistula | Renal and urinary disorders | Systematic Assessment |
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| Urinary tract obstruction | Renal and urinary disorders | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Gastrointestinal disorders | Gastrointestinal disorders | Systematic Assessment |
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| Hemorrhoiids | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Proctitis | Gastrointestinal disorders | Systematic Assessment |
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| Rectal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Rectal pain | Gastrointestinal disorders | Systematic Assessment |
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| Salivary duct inflammation | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Edema limbs | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | Systematic Assessment |
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| ry tract infection | Infections and infestations | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | Systematic Assessment |
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| Neutrophil count decreased | Investigations | Systematic Assessment |
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| Platelet count decreased | Investigations | Systematic Assessment |
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| Weight loss | Investigations | Systematic Assessment |
|
| White blood cell decreased | Investigations | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
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| Avascular necrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Muscle weakness upper limb | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
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| Cystitis noninfective | Renal and urinary disorders | Systematic Assessment |
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| Renal and urinary disorders | Renal and urinary disorders | Systematic Assessment |
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| Urinary frequency | Renal and urinary disorders | Systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | Systematic Assessment |
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| Urinary tract pain | Renal and urinary disorders | Systematic Assessment |
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| Urinary urgency | Renal and urinary disorders | Systematic Assessment |
|
| Dyspareunia | Reproductive system and breast disorders | Systematic Assessment |
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| Pelvic pain | Reproductive system and breast disorders | Systematic Assessment |
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| Vaginal hemorrhage | Reproductive system and breast disorders | Systematic Assessment |
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| Vaginismus | Reproductive system and breast disorders | Systematic Assessment |
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| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hot flashes | Vascular disorders | Systematic Assessment |
|
| Lymphedema | Vascular disorders | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | Systematic Assessment |
|
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| 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 |