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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00136258 | Other Identifier | University of Michigan | |
| U01CA183848 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| VA Ann Arbor Healthcare System | FED |
| National Cancer Institute (NCI) | NIH |
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This prospective study aims to utilize pre- and mid-treatment PET-CT to guide de-escalation of radiation therapy in HPV-related squamous cell carcinoma of the oropharynx.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Treatment | Active Comparator | Patients will receive a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy) |
|
| De-escalation Treatment | Experimental | Patients will initially receive a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). If certain parameters are met radiation therapy will be reduced to 54Gy to high risk Planned Target Volume (PTV) and 43.2Gy to low risk PTV all in 27 fractions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin | Drug | AUC=1 weekly during radiation therapy. Carboplatin will be given once a week in combination with paclitaxel (standard treatment), concurrent with radiation therapy. Given IV. |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Patients With Local Regional Recurrence (LRR) of Disease | RECIST (Response Evaluation Criteria In Solid Tumors) will be used to evaluate response and recurrence. All patients will be analyzed together as the goal of the study is to estimate risk of LRR in this patient population treated with this particular strategy in which some patients continue to receive standard therapy while others are de-escalated. Results will also be estimated and reported separately for patients receiving standard or de-escalated therapy. | 1 Year |
| Change in Metabolic Tumor Volume 50% (MTV 50%) | The change in metabolic tumor volume (MTV)50% at the mid-treatment timepoint will be calculated as percent change from baseline and used as a continuous variable in a Cox model for an outcome of time to LRR. Will also evaluate more non-parametrically, the relation between hazard of LRR and mid-treatment MTV50% using a kernel estimator in a Cox model. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Assessed Per the Functional Assessment of Cancer Therapy-Head and Neck (FACTHN) | Quality of life (QOL) outcomes and swallowing study results will be summarized descriptively by timepoint. If there is substantial missingness in the QOL outcomes the study will assess for informative missingness by comparing earlier QOL scores and change in earlier QOL scores between patients missing QOL at later time points (e.g. 1 or 2 years). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Mierzwa, M.D. | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Hospital | Ann Arbor | Michigan | 48109 | United States | ||
| VA Ann Arbor Healthcare System |
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6 subjects were removed from the trial before being assigned a cohort.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Treatment | Patients received a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy) Carboplatin: AUC=1 weekly during radiation therapy. Carboplatin will be given once a week in combination with paclitaxel (standard treatment), concurrent with radiation therapy. Given IV. Radiation Therapy: Patients will initially receive a single prescription of 70 Gy to PTV1 in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). Dose will be reduced to 54Gy to high risk PTV and 43.2Gy to low risk PTV all in 27 fractions for patients who meet pPET-CT and iPET-CT parameters. Paclitaxel: 30 mg/m2 weekly during radiation therapy. Paclitaxel will be given once a week in combination with carboplatin (standard treatment), concurrent with radiation therapy. Given IV. |
| FG001 | De-escalation Treatment | Patients initially received a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). If certain parameters are met radiation therapy will be reduced to 54Gy to high risk Planned Target Volume (PTV) and 43.2Gy to low risk PTV all in 27 fractions. Carboplatin: AUC=1 weekly during radiation therapy. Carboplatin will be given once a week in combination with paclitaxel (standard treatment), concurrent with radiation therapy. Given IV. Radiation Therapy: Patients will initially receive a single prescription of 70 Gy to PTV1 in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). Dose will be reduced to 54Gy to high risk PTV and 43.2Gy to low risk PTV all in 27 fractions for patients who meet pPET-CT and iPET-CT parameters. Paclitaxel: 30 mg/m2 weekly during radiation therapy. Paclitaxel will be given once a week in combination with carboplatin (standard treatment), concurrent with radiation therapy. Given IV. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Treatment | Patients received a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy) Carboplatin: AUC=1 weekly during radiation therapy. Carboplatin will be given once a week in combination with paclitaxel (standard treatment), concurrent with radiation therapy. Given IV. Radiation Therapy: Patients will initially receive a single prescription of 70 Gy to PTV1 in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). Dose will be reduced to 54Gy to high risk PTV and 43.2Gy to low risk PTV all in 27 fractions for patients who meet pPET-CT and iPET-CT parameters. Paclitaxel: 30 mg/m2 weekly during radiation therapy. Paclitaxel will be given once a week in combination with carboplatin (standard treatment), concurrent with radiation therapy. Given IV. |
| 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 | The Percentage of Patients With Local Regional Recurrence (LRR) of Disease | RECIST (Response Evaluation Criteria In Solid Tumors) will be used to evaluate response and recurrence. All patients will be analyzed together as the goal of the study is to estimate risk of LRR in this patient population treated with this particular strategy in which some patients continue to receive standard therapy while others are de-escalated. Results will also be estimated and reported separately for patients receiving standard or de-escalated therapy. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 Year |
|
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
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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 | Standard Treatment | Patients received a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy) Carboplatin: AUC=1 weekly during radiation therapy. Carboplatin will be given once a week in combination with paclitaxel (standard treatment), concurrent with radiation therapy. Given IV. Radiation Therapy: Patients will initially receive a single prescription of 70 Gy to PTV1 in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). Dose will be reduced to 54Gy to high risk PTV and 43.2Gy to low risk PTV all in 27 fractions for patients who meet pPET-CT and iPET-CT parameters. Paclitaxel: 30 mg/m2 weekly during radiation therapy. Paclitaxel will be given once a week in combination with carboplatin (standard treatment), concurrent with radiation therapy. Given IV. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin | University of Michigan Rogel Cancer Center | 734-936-9499 | ClinicalTrialsgov_CCAdmin@umich.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 | Apr 12, 2022 | May 3, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 12, 2023 | Oct 25, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009959 | Oropharyngeal Neoplasms |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D011878 | Radiotherapy |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D013812 | Therapeutics |
| D043823 | Taxoids |
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| Radiation Therapy | Radiation | Patients will initially receive a single prescription of 70 Gy to PTV1 in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). Dose will be reduced to 54Gy to high risk PTV and 43.2Gy to low risk PTV all in 27 fractions for patients who meet pPET-CT and iPET-CT parameters. |
|
| Paclitaxel | Drug | 30 mg/m2 weekly during radiation therapy. Paclitaxel will be given once a week in combination with carboplatin (standard treatment), concurrent with radiation therapy. Given IV. |
|
| 2 Years |
| The Proportion of Patients Alive | 2 Years |
| Incidence of Toxicity | Toxicity outcomes will be estimated as proportions of patients with available toxicity data at 3, 6 12 and 24 months. | 3, 6, 12 and 24 Months |
| Detectable Circulating Tumor Deoxyribonucleic Acid (ctDNA) in Participants | The proportion of patients in whom ctDNA is detectable will be summarized as a binomial proportion at each timepoint. Additionally, the relation between ctDNA presence or other characteristics and patient outcomes including time to local or distant progression will be assessed by including ctDNA as a covariate in Cox models for local or distant control. | 4 weeks |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| BG001 | De-escalation Treatment | Patients initially received a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). If certain parameters are met radiation therapy will be reduced to 54Gy to high risk Planned Target Volume (PTV) and 43.2Gy to low risk PTV all in 27 fractions. Carboplatin: AUC=1 weekly during radiation therapy. Carboplatin will be given once a week in combination with paclitaxel (standard treatment), concurrent with radiation therapy. Given IV. Radiation Therapy: Patients will initially receive a single prescription of 70 Gy to PTV1 in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). Dose will be reduced to 54Gy to high risk PTV and 43.2Gy to low risk PTV all in 27 fractions for patients who meet pPET-CT and iPET-CT parameters. Paclitaxel: 30 mg/m2 weekly during radiation therapy. Paclitaxel will be given once a week in combination with carboplatin (standard treatment), concurrent with radiation therapy. Given IV. |
| BG002 | 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 | Number | participants |
|
| OG001 | De-escalation Treatment | Patients initially received a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). If certain parameters are met radiation therapy will be reduced to 54Gy to high risk Planned Target Volume (PTV) and 43.2Gy to low risk PTV all in 27 fractions. Carboplatin: AUC=1 weekly during radiation therapy. Carboplatin will be given once a week in combination with paclitaxel (standard treatment), concurrent with radiation therapy. Given IV. Radiation Therapy: Patients will initially receive a single prescription of 70 Gy to PTV1 in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). Dose will be reduced to 54Gy to high risk PTV and 43.2Gy to low risk PTV all in 27 fractions for patients who meet pPET-CT and iPET-CT parameters. Paclitaxel: 30 mg/m2 weekly during radiation therapy. Paclitaxel will be given once a week in combination with carboplatin (standard treatment), concurrent with radiation therapy. Given IV. |
|
|
| Primary | Change in Metabolic Tumor Volume 50% (MTV 50%) | The change in metabolic tumor volume (MTV)50% at the mid-treatment timepoint will be calculated as percent change from baseline and used as a continuous variable in a Cox model for an outcome of time to LRR. Will also evaluate more non-parametrically, the relation between hazard of LRR and mid-treatment MTV50% using a kernel estimator in a Cox model. | 2 patients were not evaluable | Posted | Mean | Standard Deviation | percent change from baseline | 2 months |
|
|
|
| Secondary | Quality of Life Assessed Per the Functional Assessment of Cancer Therapy-Head and Neck (FACTHN) | Quality of life (QOL) outcomes and swallowing study results will be summarized descriptively by timepoint. If there is substantial missingness in the QOL outcomes the study will assess for informative missingness by comparing earlier QOL scores and change in earlier QOL scores between patients missing QOL at later time points (e.g. 1 or 2 years). | Not Posted | 2 Years | Participants |
| Secondary | The Proportion of Patients Alive | Not Posted | 2 Years | Participants |
| Secondary | Incidence of Toxicity | Toxicity outcomes will be estimated as proportions of patients with available toxicity data at 3, 6 12 and 24 months. | Not Posted | 3, 6, 12 and 24 Months | Participants |
| Secondary | Detectable Circulating Tumor Deoxyribonucleic Acid (ctDNA) in Participants | The proportion of patients in whom ctDNA is detectable will be summarized as a binomial proportion at each timepoint. Additionally, the relation between ctDNA presence or other characteristics and patient outcomes including time to local or distant progression will be assessed by including ctDNA as a covariate in Cox models for local or distant control. | Not Posted | 4 weeks | Participants |
| 2 |
| 49 |
| 5 |
| 49 |
| 49 |
| 49 |
| EG001 | De-escalation Treatment | Patients initially received a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). If certain parameters are met radiation therapy will be reduced to 54Gy to high risk Planned Target Volume (PTV) and 43.2Gy to low risk PTV all in 27 fractions. Carboplatin: AUC=1 weekly during radiation therapy. Carboplatin will be given once a week in combination with paclitaxel (standard treatment), concurrent with radiation therapy. Given IV. Radiation Therapy: Patients will initially receive a single prescription of 70 Gy to PTV1 in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). Dose will be reduced to 54Gy to high risk PTV and 43.2Gy to low risk PTV all in 27 fractions for patients who meet pPET-CT and iPET-CT parameters. Paclitaxel: 30 mg/m2 weekly during radiation therapy. Paclitaxel will be given once a week in combination with carboplatin (standard treatment), concurrent with radiation therapy. Given IV. | 1 | 36 | 3 | 36 | 36 | 36 |
| Aspiration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | Non-systematic Assessment |
|
| Oral hemorrhage | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Oral pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Thromboembolic event | Vascular disorders | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment |
|
| Anemia | Investigations | Non-systematic Assessment |
|
| Anorexia | Psychiatric disorders | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dehydration | General disorders | Non-systematic Assessment |
|
| Dermatitis radiation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dizziness | General disorders | Non-systematic Assessment |
|
| Dry mouth | General disorders | Non-systematic Assessment |
|
| Dysgeusia | General disorders | Non-systematic Assessment |
|
| Dysphagia | General disorders | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Esophageal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| Lymphedema | Vascular disorders | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | Non-systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Oral pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain | General disorders | Non-systematic Assessment |
|
| Radiation recall reaction (dermatologic) | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Sore throat | General disorders | Non-systematic Assessment |
|
| Thrush | Infections and infestations | Non-systematic Assessment |
|
| Trismus | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Weight loss | Investigations | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | Non-systematic Assessment |
|
Not provided
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| D009369 | Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D043822 |
| Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |