Stage IV Non-Small Cell Lung CancerPhase 2NCT02045446
Maintenance Chemotherapy Versus Consolidative Stereotactic Body Radiation Therapy (SBRT) Plus Maintenance Chemotherapy for Stage IV Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II Trial
A Phase 2 study testing Stereotactic Body Radiation Therapy and Maintenance chemotherapy in people with Stage IV Non-Small Cell Lung Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The core hypothesis to be tested is that the use of consolidative SBRT followed by maintenance chemotherapy in patients with less than or equal to 6 metastatic sites (primary + 5) will improve progression free survival (PFS) compared to maintenance chemotherapy alone. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Stage IV Non-Small Cell Lung Cancer
- What is being tested?
- Stereotactic Body Radiation Therapy and Maintenance chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to 2 May 2022
- Phase
- Phase 2
- 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
- Patients must have biopsy proven metastatic NSCLC (Stage IV).
- Patients must have received first line chemotherapy, from 4-6 cycles, and achieved stable disease or a partial response.
- Patients receiving first-line erlotinib, crizotinib for EGFR mutant-positive or EML4-ALK positive NSCLC will be excluded.
- Age ≥ 18 years
- Patients must have measurable disease at baseline.
- Patients can have up to only 6 discrete active extracranial lesions (≤3 in the liver and ≤3 in the lung) identified by diagnostic CT or PET/CT scan or MRI within 8 weeks prior to the initiation of SBRT.
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- For patients who have received prior radiotherapy to the primary site in the lung, residual PET activity is difficult to interpret and will not be considered a site of active disease if the CT appearance is stable or improved over an interval of at least three months
- Patients who previously received radiotherapy to the primary site will be ineligible if there is CT evidence of disease progression within the past 3 months.
- Patients with previously un-irradiated primary sites will be potentially eligible, but special considerations apply (section 4.3.2).
- Up to 2 contiguous vertebral metastases will be considered a single site of disease.
- Patients must have a KPS >60
- AST, ALT \& Alkaline phosphates must be ≤ 2.5X the upper limit of normal. Total bilirubin must be within the limit of normal.
- Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm³.
- Patients should have adequate renal function (serum creatinine ≤1.5 times the ULN).
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- 11.1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Patients who would be receiving SBRT for lung tumors who are known or suspected by the treating radiation oncologist to have compromised lung function must have a documented forced expiratory volume in 1 second (FEV1) ≥ 1L.
- Patients must provide verbal and written informed consent to participate in the study.
Who cannot join
- Patients who previously received radiotherapy to the primary site with CT evidence of disease progression at the primary site within 3 months following the initial radiotherapy.
- Patients with untreated brain metastases Patients with serious, uncontrolled, concurrent infection(s).
- Significant weight loss (>10%) in the prior 3 months.
- Because the tolerance dose of SBRT to the gastrointestinal tract is not established, patients with metastatic disease invading the esophagus, stomach, intestines, or mesenteric lymph nodes will not be eligible.
- Patients with cutaneous metastasis of NSCLC.
- Patients with more than 6 discrete extra-cranial lesions.
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- Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
- Unwillingness to participate or inability to comply with the protocol for the duration of the study.
- Patients who are pregnant. Patients with reproductive capability will need to use adequate contraception during the time of participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
The core hypothesis to be tested is that the use of consolidative SBRT followed by maintenance chemotherapy in patients with less than or equal to 6 metastatic sites (primary + 5) will improve progression free survival (PFS) compared to maintenance chemotherapy alone.
Read the detailed description
This protocol is a randomized phase II trial of maintenance chemotherapy versus consolidative Stereotactic Body Radiation Therapy (SBRT) plus maintenance chemotherapy for patients with Stage IV non-small cell lung cancer (NSCLC).
Prior to accrual on the trial, patients with Stage IV NSCLC will be treated with standard first-line chemotherapy. Patients who achieve a partial response or stable disease by imaging criteria with fewer than or equal to six sites of oligometastatic disease will be randomized to maintenance chemotherapy or consolidative SBRT to all sites of disease (followed by maintenance chemotherapy at the medical oncologist's discretion). Choices of first line and maintenance chemotherapy will be determined by the medical oncologist based on clinical appropriateness.
- Conditions
- Stage IV Non-Small Cell Lung Cancer
- Being tested
- Stereotactic Body Radiation Therapy, Maintenance chemotherapy
- 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.
Stereotactic Body Radiation TherapyRadiation
Also called SBRT
Maintenance chemotherapyDrug
Maintenance chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Maintenance chemotherapy | Active comparator | FDA approved drugs for the study population: Bevacizumab, Docetaxel, Erlotinib, Gemcitabine, Pemetrexed Receives: Drug: Maintenance chemotherapy |
| Stereotactic Body Radiation Therapy | Experimental | consolidative Stereotactic Body Radiation Therapy (SBRT) plus maintenance chemotherapy Receives: Radiation: Stereotactic Body Radiation Therapy; Drug: Maintenance chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Evaluate the effect of SBRT with maintenance chemotherapy versus maintenance chemotherapy alone on progression free survival. Time to the development of new lesions, progression of existing lesions, or death, whichever came first, represented the primary end point of progression-free survival. All evaluations of disease response used RECIST (v1.1) criteria, in which progressive disease is defined as "At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm."
Measured: 5 years
Secondary outcomes (4)
In-field Local Control Versus Out-of-field Disease Progression
Number of occurances of in-field local control and rate of out-of-field disease progression
Measured: 5 years
Toxicities
To evaluate the safety of SBRT with metastatic NSCLC after prior chemotherapy
Measured: 2 years
Overall Survival
To evaluate overall survival after SBRT followed by maintenance chemotherapy in comparison to maintenance chemotherapy alone.
Measured: 5 years
Duration of Maintenance Chemotherapy
To evaluate the duration of maintenance chemotherapy and time to initiation of third line systemic agent (chemotherapy or biologic agent)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completion17 Feb 2022
- Study completion2 May 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage IV 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Puneeth Iyengar, University of Texas Southwestern Medical Center
- Investigators
- Puneeth Iyengar, MD, Principal investigator, UTSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045446
- Sponsor's protocol ID
- STU 092013-070
- Status last verified
- Apr 2023
- First submitted
- 14 Jan 2014
- Last updated
- 23 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Iyengar P, Wardak Z, Gerber DE, Tumati V, Ahn C, Hughes RS, Dowell JE, Cheedella N, Nedzi L, Westover KD, Pulipparacharuvil S, Choy H, Timmerman RD. Consolidative Radiotherapy for Limited Metastatic Non-Small-Cell Lung Cancer: A Phase 2 Randomized Clinical Trial. JAMA Oncol. 2018 Jan 11;4(1):e173501. doi: 10.1001/jamaoncol.2017.3501. Epub 2018 Jan 11.
PubMed 28973074
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Chemotherapy Versus Consolidative Stereotactic Body Radiation Therapy (SBRT) Plus Maintenance Chemotherapy for Stage IV Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II Trial
- ClinicalTrials.gov ID
- NCT02045446
- Acronym / sponsor ID
- STU 092013-070
- Conditions
- Stage IV Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 2 May 2022 (actual)
- First posted
- 24 Jan 2014 (estimated)
- Results
- Posted 7 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The core hypothesis to be tested is that the use of consolidative SBRT followed by maintenance chemotherapy in patients with less than or equal to 6 metastatic sites (primary + 5) will improve progression free survival (PFS) compared to maintenance chemotherapy alone.
Detailed description
This protocol is a randomized phase II trial of maintenance chemotherapy versus consolidative Stereotactic Body Radiation Therapy (SBRT) plus maintenance chemotherapy for patients with Stage IV non-small cell lung cancer (NSCLC).
Prior to accrual on the trial, patients with Stage IV NSCLC will be treated with standard first-line chemotherapy. Patients who achieve a partial response or stable disease by imaging criteria with fewer than or equal to six sites of oligometastatic disease will be randomized to maintenance chemotherapy or consolidative SBRT to all sites of disease (followed by maintenance chemotherapy at the medical oncologist's discretion). Choices of first line and maintenance chemotherapy will be determined by the medical oncologist based on clinical appropriateness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maintenance chemotherapy | Active comparator | Drug: Maintenance chemotherapyFDA approved drugs for the study population: Bevacizumab, Docetaxel, Erlotinib, Gemcitabine, Pemetrexed |
| Stereotactic Body Radiation Therapy | Experimental | Radiation: Stereotactic Body Radiation Therapy, Drug: Maintenance chemotherapyconsolidative Stereotactic Body Radiation Therapy (SBRT) plus maintenance chemotherapy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patients must have biopsy proven metastatic NSCLC (Stage IV).
- Patients must have received first line chemotherapy, from 4-6 cycles, and achieved stable disease or a partial response.
- Patients receiving first-line erlotinib, crizotinib for EGFR mutant-positive or EML4-ALK positive NSCLC will be excluded.
- Age ≥ 18 years
- Patients must have measurable disease at baseline.
Key exclusion criteria (9 listed)
- Patients who previously received radiotherapy to the primary site with CT evidence of disease progression at the primary site within 3 months following the initial radiotherapy.
- Patients with untreated brain metastases Patients with serious, uncontrolled, concurrent infection(s).
- Significant weight loss (>10%) in the prior 3 months.
- Because the tolerance dose of SBRT to the gastrointestinal tract is not established, patients with metastatic disease invading the esophagus, stomach, intestines, or mesenteric lymph nodes will not be eligible.
- Patients with cutaneous metastasis of NSCLC.
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 |
|---|---|---|
| Stereotactic Body Radiation TherapyAlso: SBRT | Radiation | Stereotactic Body Radiation Therapy |
| Maintenance chemotherapyMaintenance chemotherapy | Drug | Maintenance chemotherapy, Stereotactic Body Radiation Therapy |
Primary outcome
Progression Free Survival
Time frame: 5 years
Evaluate the effect of SBRT with maintenance chemotherapy versus maintenance chemotherapy alone on progression free survival. Time to the development of new lesions, progression of existing lesions, or death, whichever came first, represented the primary end point of progression-free survival. All evaluations of disease response used RECIST (v1.1) criteria, in which progressive disease is defined as "At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm."
4 secondary outcomes
In-field Local Control Versus Out-of-field Disease Progression
Time frame: 5 years
Toxicities
Time frame: 2 years
Overall Survival
Time frame: 5 years
Duration of Maintenance Chemotherapy
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28973074Iyengar P, Wardak Z, Gerber DE, Tumati V, Ahn C, Hughes RS, Dowell JE, Cheedella N, Nedzi L, Westover KD, Pulipparacharuvil S, Choy H, Timmerman RD. Consolidative Radiotherapy for Limited Metastatic Non-Small-Cell Lung Cancer: A Phase 2 Randomized Clinical Trial. JAMA Oncol. 2018 Jan 11;4(1):e173501. doi: 10.1001/jamaoncol.2017.3501. Epub 2018 Jan 11.
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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.
Puneeth Iyengar, MD principal investigator
UTSW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic Body Radiation Therapy and Maintenance chemotherapy in people with Stage IV Non-Small Cell Lung Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 20 inclusion and 9 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 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2023). 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?
Progression Free Survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02045446, which also lists 1 linked publication.
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 23 May 2023.