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The study is designed to determine whether daily image guidance and motion assessment/control will allow treatment of poor performance status patients with stage II-IV NSCLC, who would benefit from local therapy, with an accelerated course of hypofractionated radiation therapy.
Subjects for this study will be enrolled by the Moncrief Radiation oncology Department at the Simmons Cancer Center.
Primary objective: To escalate the dose of accelerated, hypofractionated, image-guided conformal radiotherapy to a potent tumorcidal dose without exceeding the maximum tolerated dose in treatment of stage ii-iV nSCLC in patients with poor performance status.
Secondary objectives: To evaluate local regional tumor control and overall survival in patients with stage ii-iV nSCLC and poor performance status treated with accelerated, hypofractionated, image-guided conformal radiotherapy.
Schema
number of patients between 7-45 (depending on tolerance)
Patients in each dose cohort will all be treated as a single group for dose escalation. The starting dose will be 3.33 Gy per fraction for 15 fractions (total dose 50 Gy). Subsequent cohorts of patients will receive a higher dose per fraction as follows:
Cohort No. Fractions Dose per fraction (Gy) Total Dose (Gy) No. Patients
Minimum waiting periods will be assigned between each dose cohort to observe toxicity.
Screening Procedures
each study participant will have the following exams, tests or procedure to help determine if they are qualified to be in this study:
Within 8 weeks of enrollment :
Within 3 days prior to radiotherapy: urine or serum pregnancy test in females of child-bearing capacity.
Within 12 weeks of enrollment:
* Pulmonary function tests including spirometry for forced expiratory volume in 1 second (FeV-1), diffusing capacity (DLCo), and arterial blood gas (Pao-2).
Prior to enrollment on the study: Tissue biopsy or cytology confirming non-small cell lung cancer.
Treatment Protocol treatment must begin within 4 weeks after patient registration to the trial. Patients will receive 15 fractions of radiation. Total dose will depend on the dose cohort of the study (see schema). The starting dose level will be 3.33 Gy per fraction for 15 fractions (total dose [?] 50 Gy).
Patients must not receive other concomitant antineoplastic therapy (including standard fractionated radiotherapy to the chest, chemotherapy, biological therapy, vaccine therapy, and surgery) within a week prior to, during, or within one week after completing hypofractionated image-guided radiation therapy on protocol.
Follow-up Patients will be followed until death.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Level A: IGRT 3.33Gy x 15 Fractions | Experimental | Image-guided radiation therapy (IGRT) dose of 3.33Gy for 15 fractions (total dose = 50 Gy) which is given over the course of about 3 weeks |
|
| Dose Level B: IGRT 3.67Gy x 15 Fractions | Experimental | Image-guided radiation therapy (IGRT) dose of 3.67Gy for 15 fractions (total dose = 55 Gy) which is given over the course of about 3 weeks |
|
| Dose Level C: IGRT 4.00Gy x 15 Fractions | Experimental | Image-guided radiation therapy (IGRT) dose of 3.67Gy for 15 fractions (total dose = 60 Gy) which is given over the course of about 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Image-Guided Radiation Therapy | Radiation | Radiotherapy to a potent tumorcidal dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicity | A dose limiting toxicity (DLT) is defined as treatment-related (definitely and probably, but not possibly related to treatment*) grade 3 adverse events (per CTCAE, v.3.0, with the exception of pulmonary function tests) | 90 days after start of treatment up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Local Regional Tumor Control at 3 Months | Local control is defined as the absence of isolated progression (stable disease or responsive disease at last follow-up) within the primary tumor. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Timmerman | University of Texas Southwestern Medical Center | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Level A: IGRT 3.33Gy x 15 Fractions (Total 50 Gy) | Image-guided radiation therapy (IGRT) dose which is given over the course of about 3 weeks Patients with stage II to IV or recurrent NSCLC and Eastern Cooperative Oncology Group performance status of 2 or greater and not candidates for surgical resection, stereotactic radiation, or concurrent chemoradiation were eligible. Highly conformal radiation therapy was given to treat intrathoracic disease in 15 fractions to a total of 50, 55, or 60 Gy. |
| FG001 | Dose Level B: IGRT 3.67Gy x 15 Fractions (Total 55-Gy ) | Image-guided radiation therapy (IGRT) which is given over the course of about 3 weeks Patients with stage II to IV or recurrent NSCLC and Eastern Cooperative Oncology Group performance status of 2 or greater and not candidates for surgical resection, stereotactic radiation, or concurrent chemoradiation were eligible. Highly conformal radiation therapy was given to treat intrathoracic disease in 15 fractions to a total of 50, 55, or 60 Gy. |
| FG002 | Dose Level C: IGRT 4Gy x 15 Fractions ( Total 60Gy) | 4 Gy per fraction for a total dose of 60 Gy will be tested. Image-guided radiation therapy (IGRT) dose which is given over the course of about 3 weeks Patients with stage II to IV or recurrent NSCLC and Eastern Cooperative Oncology Group performance status of 2 or greater and not candidates for surgical resection, stereotactic radiation, or concurrent chemoradiation were eligible. Highly conformal radiation therapy was given to treat intrathoracic disease in 15 fractions to a total of 50, 55, or 60 Gy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Level A: IGRT 3.33Gy x 15 Fractions (Total 50Gy) | Image-guided radiation therapy (IGRT) does of 3.33Gy for 15 fractions (total dose = 50 Gy) which is given over the course of about 3 weeks |
| BG001 | Dose Level B: IGRT 3.67Gy x 15 Fractions (Total 55Gy) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Number of Participants With Dose Limiting Toxicity | A dose limiting toxicity (DLT) is defined as treatment-related (definitely and probably, but not possibly related to treatment*) grade 3 adverse events (per CTCAE, v.3.0, with the exception of pulmonary function tests) | Posted | Count of Participants | Participants | 90 days after start of treatment up to 1 year |
|
This was collected over a period of 12 months.
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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 A: IGRT 3.33Gy x 15 Fractions (50 Gy) | 14 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| G2 or higher dyspnea | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ≤G2 Esophagitis | General disorders | Systematic Assessment |
Planned statistical analysis was not able to be performed due to the poor overall survival of the study population.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Hardee | UT Southwestern Medical Center | 214-648-1836 | sarah.hardee@utsouthwestern.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 6, 2014 | Aug 9, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D061089 | Radiotherapy, Image-Guided |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| Number of Participants With Local Regional Tumor Control at 6 Months | Local control is defined as the absence of isolated progression (stable disease or responsive disease at last follow-up) within the primary tumor. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions. | 6 months |
| Number of Participants With Local Regional Tumor Control at 9 Months | Local control is defined as the absence of isolated progression (stable disease or responsive disease at last follow-up) within the primary tumor. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions. | 9 months |
| Number of Participants With Local Regional Tumor Control at 12 Months | Local control is defined as the absence of isolated progression (stable disease or responsive disease at last follow-up) within the primary tumor. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions. | 12 months |
| Number of Participants With Local Regional Tumor Control at 16 Months | Local control is defined as the absence of isolated progression (stable disease or responsive disease at last follow-up) within the primary tumor. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions. | 16 months |
| Number of Participants With Local Regional Tumor Control at 20 Months | Local control is defined as the absence of isolated progression (stable disease or responsive disease at last follow-up) within the primary tumor. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions. | 20 months |
| Overall Survival at 6 Months | Overall survival is defined as participants alive during the research period. | 6 months |
Image-guided radiation therapy (IGRT) dose of 3.67Gy for 15 fractions (total dose = 55 Gy) which is given over the course of about 3 weeks |
| BG002 | Dose Level C: IGRT 4Gy x 15 Fractions ( Total 60Gy) | 4 Gy per fraction for a total dose of 60 Gy will be tested. Image-guided radiation therapy (IGRT) dose which is given over the course of about 3 weeks Patients with stage II to IV or recurrent NSCLC and Eastern Cooperative Oncology Group performance status of 2 or greater and not candidates for surgical resection, stereotactic radiation, or concurrent chemoradiation were eligible. Highly conformal radiation therapy was given to treat intrathoracic disease in 15 fractions to a total of 50, 55, or 60 Gy. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Dose Level C: IGRT 4.00Gy x 15 Fractions (60 Gy) | In this cohort, the starting dose of Image-Guided Radiation Therapy (IGRT) will be 4.00 Gy per fraction for 15 fractions (total dose = 60 Gy). |
|
|
| Secondary | Number of Participants With Local Regional Tumor Control at 3 Months | Local control is defined as the absence of isolated progression (stable disease or responsive disease at last follow-up) within the primary tumor. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions. | Only convenient sample were included. Those who died, lost to follow-up, refused scans were not included | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Number of Participants With Local Regional Tumor Control at 6 Months | Local control is defined as the absence of isolated progression (stable disease or responsive disease at last follow-up) within the primary tumor. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions. | Only convenient sample were included. Those who died, lost to follow-up, refused scans were not included | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Number of Participants With Local Regional Tumor Control at 9 Months | Local control is defined as the absence of isolated progression (stable disease or responsive disease at last follow-up) within the primary tumor. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions. | Only convenient sample were included. Those who died, lost to follow-up, refused scans were not included | Posted | Count of Participants | Participants | 9 months |
|
|
|
| Secondary | Number of Participants With Local Regional Tumor Control at 12 Months | Local control is defined as the absence of isolated progression (stable disease or responsive disease at last follow-up) within the primary tumor. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions. | Only convenient sample were included. Those who died, lost to follow-up, refused scans were not included | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Number of Participants With Local Regional Tumor Control at 16 Months | Local control is defined as the absence of isolated progression (stable disease or responsive disease at last follow-up) within the primary tumor. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions. | Only convenient sample were included. Those who died, lost to follow-up, refused scans were not included | Posted | Count of Participants | Participants | 16 months |
|
|
|
| Secondary | Number of Participants With Local Regional Tumor Control at 20 Months | Local control is defined as the absence of isolated progression (stable disease or responsive disease at last follow-up) within the primary tumor. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions. | Only convenient sample were included. Those who died, lost to follow-up, refused scans were not included | Posted | Count of Participants | Participants | 20 months |
|
|
|
| Secondary | Overall Survival at 6 Months | Overall survival is defined as participants alive during the research period. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 5 |
| 15 |
| 15 |
| 15 |
| EG001 | Dose Level B: IGRT 3.67Gy x 15 Fractions (55 Gy) | 14 | 21 | 4 | 21 | 20 | 21 |
| EG002 | Dose Level C: IGRT 4.00Gy x 15 Fractions (60 Gy | 11 | 19 | 4 | 19 | 18 | 19 |
| G2 or higher Esophagitis | General disorders | Systematic Assessment |
|
| ≤G2 Dyspnea | Cardiac disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Anorexia | Psychiatric disorders | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dysphagia | General disorders | Systematic Assessment |
|
| Pain | Nervous system disorders | Systematic Assessment |
|
| Anxiety | Nervous system disorders | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Confusion | Nervous system disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | Systematic Assessment |
|
| Delirium | Psychiatric disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Dysarthria | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypotension | Cardiac disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Neuropathy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment | Pulmonary/ Upper Respiratory Infection: Lung (Pnemonia) |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Syncope | Nervous system disorders | Systematic Assessment |
|
| Thrombosis | Vascular disorders | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |