Non-small Cell Lung CancerNCT03623334
Phase I Study of Accelerated Hypofractionated Image-Guided Radiation Therapy
A study testing Image-Guided Radiation Therapy in people with Non-small Cell Lung Cancer, run by University of Texas Southwestern Medical Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Image-Guided Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 5 Oct 2009to 10 Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients must be willing and capable to provide informed consent to participate in the protocol.
- Patients must have appropriate staging studies identifying them as AJCC stage II, III or IV non small cell lung cancer, [according to AJCC Staging, 6th edition; see appendix III], or recurrent non small cell lung cancer. Histologic confirmation of cancer will be required by biopsy or cytology.
- Patients must have the potential for benefit from local therapy (at the discretion of the investigator).
- Patient must have a Zubrod performance status of 2 or greater Or Patient must have had >10% weight loss in the past 6 months Or Patient is not eligible for concurrent chemoradiation as determined by a Medical Oncologist and Radiation Oncologist
- Age ≥ 18.
- The tumor must be ineligible for definitive surgical resection.
Show all 11Show fewer
- The tumor must be ineligible for stereotactic body radiation therapy.
- Patients must have measurable or evaluable disease.
- Women of childbearing potential and male participants must agree to use an effective method of contraception.
- Patients must sign study specific informed consent prior to study entry.
- Patients must complete all required pretreatment evaluations
Who cannot join
- Evidence of small cell histology.
- Tumor eligible for definitive surgical resection.
- Tumor eligible for definitive stereotactic body radiation therapy.
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
- Chemotherapy given within one week of study registration.
- Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.
About this study
Official title: Phase I Study of Accelerated Hypofractionated Image-Guided Radiation Therapy (IGRT) in Patients With Stage II-IV Non-Small Cell Lung Cancer and Poor Performance Status
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.
Read the detailed description
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
- 15 3.33 50 7-15
- 15 3.67 55 7-15
- 15 4.00 60 7-15
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 :
- Computed tomographic (CT) with contrast of the lung and upper abdomen. a CT done in conjunction with a Positron emission Tomography (PeT) scan is satisfactory as long as the images are of adequate quality to be interpreted by a radiologist.
- an MRi of the brain with contrast (or CT if MRi is medically contraindicated).
- Complete Blood Count (CBC) with differential
- Charleston Comorbidity index completion
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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Image-Guided Radiation Therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image-Guided Radiation TherapyRadiation
Radiotherapy to a potent tumorcidal dose
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: Image-Guided Radiation Therapy |
| 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 Receives: Radiation: Image-Guided Radiation Therapy |
| 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 Receives: Radiation: Image-Guided Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 90 days after start of treatment up to 1 year
Secondary outcomes (7)
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.
Measured: 3 months
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 20 months
Overall Survival at 6 Months
Overall survival is defined as participants alive during the research period.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start5 Oct 2009
- Primary completion2 Nov 2012
- Study completion10 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Timmerman, University of Texas Southwestern Medical Center
- Investigators
- Robert Timmerman, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623334
- Sponsor's protocol ID
- STU 072010-050
- Status last verified
- Apr 2021
- First submitted
- 14 May 2018
- Last updated
- 4 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Accelerated Hypofractionated Image-Guided Radiation Therapy (IGRT) in Patients With Stage II-IV Non-Small Cell Lung Cancer and Poor Performance Status
- ClinicalTrials.gov ID
- NCT03623334
- Acronym / sponsor ID
- STU 072010-050
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 5 Oct 2009 (actual)
- Primary completion
- 2 Nov 2012 (actual)
- Study completion
- 10 Feb 2018 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Posted 4 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- 15 3.33 50 7-15
- 15 3.67 55 7-15
- 15 4.00 60 7-15
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 :
- Computed tomographic (CT) with contrast of the lung and upper abdomen. a CT done in conjunction with a Positron emission Tomography (PeT) scan is satisfactory as long as the images are of adequate quality to be interpreted by a radiologist.
- an MRi of the brain with contrast (or CT if MRi is medically contraindicated).
- Complete Blood Count (CBC) with differential
- Charleston Comorbidity index completion
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Level A: IGRT 3.33Gy x 15 Fractions | Experimental | Radiation: Image-Guided Radiation TherapyImage-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 | Radiation: Image-Guided Radiation TherapyImage-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 | Radiation: Image-Guided Radiation TherapyImage-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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- All patients must be willing and capable to provide informed consent to participate in the protocol.
- Patients must have appropriate staging studies identifying them as AJCC stage II, III or IV non small cell lung cancer, [according to AJCC Staging, 6th edition; see appendix III], or recurrent non small cell lung cancer. Histologic confirmation of cancer will be required by biopsy or cytology.
- Patients must have the potential for benefit from local therapy (at the discretion of the investigator).
- Patient must have a Zubrod performance status of 2 or greater Or Patient must have had >10% weight loss in the past 6 months Or Patient is not eligible for concurrent chemoradiation as determined by a Medical Oncologist and Radiation Oncologist
- Age ≥ 18.
Key exclusion criteria (6 listed)
- Evidence of small cell histology.
- Tumor eligible for definitive surgical resection.
- Tumor eligible for definitive stereotactic body radiation therapy.
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
- Chemotherapy given within one week of study registration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Image-Guided Radiation TherapyRadiotherapy to a potent tumorcidal dose | Radiation | Dose Level A: IGRT 3.33Gy x 15 Fractions, Dose Level B: IGRT 3.67Gy x 15 Fractions, Dose Level C: IGRT 4.00Gy x 15 Fractions |
Primary outcome
Number of Participants With Dose Limiting Toxicity
Time frame: 90 days after start of treatment up to 1 year
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)
7 secondary outcomes
Number of Participants With Local Regional Tumor Control at 3 Months
Time frame: 3 months
Number of Participants With Local Regional Tumor Control at 6 Months
Time frame: 6 months
Number of Participants With Local Regional Tumor Control at 9 Months
Time frame: 9 months
Number of Participants With Local Regional Tumor Control at 12 Months
Time frame: 12 months
Number of Participants With Local Regional Tumor Control at 16 Months
Time frame: 16 months
Number of Participants With Local Regional Tumor Control at 20 Months
Time frame: 20 months
Overall Survival at 6 Months
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Timmerman principal investigator
University of Texas Southwestern Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Image-Guided Radiation Therapy in people with Non-small Cell Lung Cancer, run by University of Texas Southwestern Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose Limiting Toxicity (time frame: 90 days after start of treatment up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.