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The purpose of this research study is to determine whether the amount of radiation given to the normal areas around the anal cancer can be reduced by using Proton Therapy while reducing the side effects that are seen with standard therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proton Therapy and Chemotherapy | Experimental | Standard chemoradiation using 5-FU, Mitomycin, with pencil beam proton radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton therapy | Radiation | Primary target volume 50.4-54 CGE in 28-30 fractions; Nodal volumes 42-54 CGE in 28-30 fractions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rates of Acute Toxicity | Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of Late Toxicity | Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity | every 6 months up to 60 months |
| Complete Response Rate | Complete response was clinically determined by digital rectal examination and proctosigmoidoscopy supplemented with pelvic axial imaging. Biopsy was not required. The complete response was the absence of disease based on these evaluations. Any measurable disease at 6 months from the completion of chemoradiation will be considered a local treatment failure. Any tumor recurrence in the anus in patients who initially had a complete response will be considered a local recurrence. |
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Inclusion Criteria:
Exclusion Criteria:
• Patients with a life expectancy of < 3 months.
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| Name | Affiliation | Role |
|---|---|---|
| Jordan Kharofa, MD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Health | Cincinnati | Ohio | 45044 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Stage II and III Anal Cancer | Patients with histologically confirmed squamous or basaloid carcinoma of the anal canal were eligible if they were at least 18 years old with a Karnofsky performance status > 70%, AJCC eighth edition cT2-4 disease with any N category, life expectancy >3 months, and acceptable organ and bone marrow function. Women who were not postmenopausal had to have a negative urine or serum pregnancy test. History and physical examination (including anal and groin evaluation) had to be performed within 21 days of trial registration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Proton Therapy and Chemotherapy | Standard chemoradiation using 5-FU, Mitomycin, with pencil beam proton radiotherapy Proton therapy: Primary target volume 50.4-54 CGE in 28-30 fractions; Nodal volumes 42-54 CGE in 28-30 fractions Chemotherapy: 5FU 1000 mg/m2/day as 96 hour infusion days 1-5 and 29-33; Mitomycin 10mg/m2 days 1 and 29 |
| 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 | Rates of Acute Toxicity | Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity | The population is the subjects that had at least one adverse event that was grade 3 or higher in one of the following categories: hematologic, gastrointestinal, genitourinary, and dermatologic | Posted | Count of Participants | Participants | 3 months |
|
|
AEs were collected from the start of treatment to 90 days after post treatment. If an AE was one of the subset of AEs listed below, then the AE was tracked beyond 90 days until resolution or the end of the study (60 months). The subset of AEs are: (1) AEs that may be reasonably related to the organ systems within the study treatment field (such as the GI/GU/Vaginal/Skin/pelvic bone organ systems) and (2) all SAEs.
The definition does not differ from clinicaltrials.gov.
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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 | Adverse Events for All 14 Subjects | This is a summary of adverse events for all 14 subjects in the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jordan Kharofa, MD | University of Cincinnati Cancer Center | 513-584 4775 | kharofjr@ucmail.uc.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 | Aug 31, 2020 | May 8, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001005 | Anus Neoplasms |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
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| ID | Term |
|---|---|
| D061766 | Proton Therapy |
| D004358 | Drug Therapy |
| D005472 | Fluorouracil |
| D016685 | Mitomycin |
| ID | Term |
|---|---|
| D063193 | Heavy Ion Radiotherapy |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D014498 | Uracil |
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| Chemotherapy | Drug | 5FU 1000 mg/m2/day as 96 hour infusion days 1-5 and 29-33; Mitomycin 10mg/m2 days 1 and 29 |
|
|
| at 6 months from the completion of chemoradiation |
| Local Progression Free Survival | This is the percentage of subjects that were free of local progression. | every 6 months up to 60 months |
| Overall Survival | This is an estimated percentage of participants that is alive at 2 years. | every 6 months up to 24 months |
| Distant Metastases Free Survival | This is the percentage of subjects that were free of distant metastases. | every 6 months up to 60 months |
| Quality of Life Changes | Utilization of the Patient Reported Outcomes- Common Toxicity Criteria for Adverse Events at pretreatment and up to 12 months. This measure used the difference total score for each subject's baseline and latest PROCTCAE available. The reported statistic is the number of subjects that showed a reduction in scores between the two time points. | before treatment and 12 months after start of treatment |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Rates of Late Toxicity | Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity | The population is the subjects that had at least one adverse event that was grade 3 or higher in one of the following categories: hematologic, gastrointestinal, genitourinary, and dermatologic | Posted | Count of Participants | Participants | every 6 months up to 60 months |
|
|
|
| Secondary | Complete Response Rate | Complete response was clinically determined by digital rectal examination and proctosigmoidoscopy supplemented with pelvic axial imaging. Biopsy was not required. The complete response was the absence of disease based on these evaluations. Any measurable disease at 6 months from the completion of chemoradiation will be considered a local treatment failure. Any tumor recurrence in the anus in patients who initially had a complete response will be considered a local recurrence. | Posted | Count of Participants | Participants | at 6 months from the completion of chemoradiation |
|
|
|
| Secondary | Local Progression Free Survival | This is the percentage of subjects that were free of local progression. | Posted | Count of Participants | Participants | every 6 months up to 60 months |
|
|
|
| Secondary | Overall Survival | This is an estimated percentage of participants that is alive at 2 years. | time from the date of registration to the date of death due to all causes | Posted | Number | 95% Confidence Interval | percentage of subjects | every 6 months up to 24 months |
|
|
|
| Secondary | Distant Metastases Free Survival | This is the percentage of subjects that were free of distant metastases. | Posted | Count of Participants | Participants | every 6 months up to 60 months |
|
|
|
| Secondary | Quality of Life Changes | Utilization of the Patient Reported Outcomes- Common Toxicity Criteria for Adverse Events at pretreatment and up to 12 months. This measure used the difference total score for each subject's baseline and latest PROCTCAE available. The reported statistic is the number of subjects that showed a reduction in scores between the two time points. | This measure examines all 14 subjects. | Posted | Count of Participants | Participants | before treatment and 12 months after start of treatment |
|
|
|
| 2 |
| 14 |
| 7 |
| 14 |
| 13 |
| 14 |
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Bullous dermatitis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Cardiac disorders - Other, specify | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment | Cardiac Pain-unspecified |
|
| Cardiac disorders - Other, specify | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment | NSTEMI - type 1 |
|
| Chest pain - cardiac | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment | Pneumonia |
|
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment | E. Coli Sepsis |
|
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment | Failure to Thrive |
|
| Pregnancy, puerperium and perinatal conditions - Other, specify | Pregnancy, puerperium and perinatal conditions | CTCAE (4.0) | Non-systematic Assessment | Placenta Increta |
|
| Psychiatric disorders - Other, specify | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment | Altered Mental Status |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Rectal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment | Acute Exacerbation of COPD |
|
| Respiratory, thoracic and mediastinal disorders - Other, specify | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment | Acute on chronic Hypoxic and Hypercarbic Respiratory Failure |
|
| Urinary tract infection | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Anal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Anal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
|
| Bullous dermatitis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Burn | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Chills | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Edema limbs | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fecal incontinence | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Floaters | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment | Stinging sensation in anal region |
|
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment | Rectal Cramping |
|
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment | dark red mucous small clot in stool |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hot flashes | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Immune system disorders - Other, specify | Immune system disorders | CTCAE (4.0) | Non-systematic Assessment | Neutropenic Fever |
|
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment | E. Coli Sepsis |
|
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment | C. Diff |
|
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment | Hospital Acquired Pneumonia |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Localized edema | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment | Failure to Thrive |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Muscle cramp | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nervous system disorders - Other, specify | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment | Sciatica |
|
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Proctitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Rectal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Renal and urinary disorders - Other, specify | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment | Urinary Hesitancy |
|
| Renal and urinary disorders - Other, specify | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment | Nocturia |
|
| Renal and urinary disorders - Other, specify | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment | Weak Stream |
|
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment | Acute Respiratory Failure |
|
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment | Erythema on face from 5FU |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment | Perianal Skin Irritation |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment | Perianal Skin Pain |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Skin ulceration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Superficial soft tissue fibrosis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Urinary tract pain | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Urinary urgency | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Urine discoloration | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Vaginal dryness | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Vaginal hemorrhage | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Weight gain | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Weight loss | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
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| D004067 |
| Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| D011744 |
| Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D008937 | Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
| D001389 | Azirines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |