Non-small Cell Lung CancerPhase 1/2NCT01222572
Stereotactic Boost for Locally Advanced Non-Small Cell Lung Cancer
A Phase 1/2 study testing Stereotactic boost, Conventional RT and Etoposide in people with Non-small Cell Lung Cancer and Lung Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
In this research study the investigators are looking for the highest dose of a stereotactic radiation boost that can be given safely. Because stereotactic radiation is so precise, the investigators are testing whether it can be used to increase the dose to the primary tumor without significantly increasing the side… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Lung Cancer, NSCLC
- What is being tested?
- Stereotactic boost, Conventional RT and Etoposide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Oct 2012
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed stage II or stage III non-small cell lung cancer, or stage IV non-small cell lung cancer that will be treated with curative intent
- Evaluated by a surgeon and deemed inoperable
- Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as 10mm or greater with chest CT scan.
- No active malignancy within the past 5 years, except for non-melanoma skin cancers or carcinoma in situ of the cervix
- 18 years or older
- Life expectancy of greater then 6 months
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Normal organ and marrow function as outlined in the protocol
- Forced expiratory volume (FEV1) of 1 L or greater OR 50% or greater of predicted
Who cannot join
- Primary tumor size greater then 6cm
- Prior history of thoracic radiotherapy
- May not be receiving any other study agents
- History of pulmonary fibrosis
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin or etoposide
- Primary tumor < 1.5 cm beyond hilar lymphadenopathy (if any) and 1.5 cm from proximal bronchial tree, defined as the trachea, right and left mainstem bronchus, and lobar bronchi until the 1st lobar segment
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- Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or breast feeding women
- Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin
- Human immunodeficiency virus (HIV)-positive individuals on combination antiretroviral therapy
- Patients who are planned to receive the following medication: granulocyte colony-stimulating factor (G-CSF), bevacizumab, cetuximab, cyclosporine, anti-tumor necrosis factor agents, amifostine.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
In this research study the investigators are looking for the highest dose of a stereotactic radiation boost that can be given safely. Because stereotactic radiation is so precise, the investigators are testing whether it can be used to increase the dose to the primary tumor without significantly increasing the side effects the participant experiences; the goal is to improve the likelihood of killing the tumor.
Read the detailed description
Primary Objectives Phase I: Determination of the MTD and dose-limiting toxicities of a stereotactic boost to chemoradiotherapy for stage II/III non-small cell lung cancer.
Phase II: Two-year local control rate
Secondary Objectives
- To evaluate the safety and tolerability of a stereotactic boost to chemoradiotherapy.
- To determine the 2-year overall survival.
- To determine the 2-year disease-free survival.
- To determine the 2-year regional control rate.
- To characterize the change in pulmonary function tests over the first 2 years after chemoradiotherapy.
Statistical Design The Phase I study followed a standard 3+3 dose escalation design. Three dose levels were evaluated. The DLT observation period was the 7-week chemoradiotherapy period and the subsequent 8-week recovery period.
To better study the toxicity at the MTD of the stereotactic boost, there was a 10 patient expansion cohort.The primary endpoint of the phase II portion of the study was two-year local failure rate of the protocol treatment. Local failure was defined as biopsy-proven recurrent disease, or if a biopsy was not attainable, by increasing FDG-avidity on PET-CT on 2 consecutive scans at least 1 month apart. Based on prior studies, a 2-year local failure rate of 15% would be worthy of further study, while a 2-year local failure rate of 35% would not justify further utilization of the treatment. With 32 eligible patients on this study, the treatment will be deemed promising if at least 25 patients are free of local failure at 2 years. Using this design, there was an 8% probability of declaring the treatment worthy of further study if the true 2-year local failure rate was 35%, and a 90% probability of declaring the treatment worthy of further study if the true 2-year local failure rate was 15% by using a one-sided one-sample exact binomial test.
- Conditions
- Non-small Cell Lung Cancer, Lung Cancer, NSCLC
- Keywords
- radiation therapy, stereotactic radiotherapy, stereotactic boost
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic boostRadiation
Also called Stereotactic Body Radiotherapy (SBRT)
Conventional RTRadiation
EtoposideDrug
CisplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Boost to Chemoradiotherapy (Dose Level 1) | Experimental | Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 54 Gy; Stereotactic Boost to Primary: 10 Gy; Total Dose to Primary: 64 Gy
- Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point. Receives: Radiation: Stereotactic boost; Radiation: Conventional RT; Drug: Etoposide; Drug: Cisplatin |
| Stereotactic Boost to Chemoradiotherapy (Dose Level 2) | Experimental | Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 50 Gy; Stereotactic Boost to Primary: 15 Gy; Total Dose to Primary: 65 Gy
- Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point. Receives: Radiation: Stereotactic boost; Radiation: Conventional RT; Drug: Etoposide; Drug: Cisplatin |
| Stereotactic Boost to Chemoradiotherapy (Dose Level 3) | Experimental | Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 46 Gy; Stereotactic Boost to Primary: 20 Gy; Total Dose to Primary: 66 Gy
- Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point. Receives: Radiation: Stereotactic boost; Radiation: Conventional RT; Drug: Etoposide; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
The MTD is determined by the number of patients who experience a dose limiting toxicity (DLT). The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached.
DLTs were defined as follows (CTCAE v4.0):
Grade 2 non-hematologic toxicities: Myelitis; Esophageal fistula, perforation, hemorrhage
Grade 3 non-hematologic toxicities considered to be a direct result of therapy:
Radiation pneumonitis; Pericarditis, pericardial effusion, pericardial tamponade; Esophageal necrosis, stenosis, ulcer; Dyspnea; Myelitis Grade 4 non-hematologic toxicities: Radiation pneumonitis; Pericarditis, pericardial effusion, pericardial tamponade; Esophagitis (not due to mediastinal irradiation unrelated to the stereotactic boost), esophageal necrosis, stenosis, ulcer; Dyspnea; Myelitis Grade 5 non-hematologic toxicity: Any
Measured: 7-week chemoradiotherapy period and the subsequent 8-week recovery period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startDec 2010
- Primary completionMar 2012
- Study completionOct 2012
Why it stopped: Slow accrual due to restrictive eligibility criteria
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 Dana-Farber Cancer InstituteThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Raymond H. Mak, Dana-Farber Cancer Institute
- Investigators
- Raymond H. Mak, MD, Principal investigator, Dana-Farber Cancer Institute/Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222572
- Sponsor's protocol ID
- 10-240
- Status last verified
- May 2015
- First submitted
- 8 Oct 2010
- Last updated
- 4 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Boost for Locally Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01222572
- Acronym / sponsor ID
- 10-240
- Conditions
- Non-small Cell Lung Cancer, Lung Cancer, NSCLC
- Keywords
- radiation therapy, stereotactic radiotherapy, stereotactic boost
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual due to restrictive eligibility criteria
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- Dec 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 18 Oct 2010 (estimated)
- Results
- Posted 5 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this research study the investigators are looking for the highest dose of a stereotactic radiation boost that can be given safely. Because stereotactic radiation is so precise, the investigators are testing whether it can be used to increase the dose to the primary tumor without significantly increasing the side effects the participant experiences; the goal is to improve the likelihood of killing the tumor.
Detailed description
Primary Objectives Phase I: Determination of the MTD and dose-limiting toxicities of a stereotactic boost to chemoradiotherapy for stage II/III non-small cell lung cancer.
Phase II: Two-year local control rate
Secondary Objectives
- To evaluate the safety and tolerability of a stereotactic boost to chemoradiotherapy.
- To determine the 2-year overall survival.
- To determine the 2-year disease-free survival.
- To determine the 2-year regional control rate.
- To characterize the change in pulmonary function tests over the first 2 years after chemoradiotherapy.
Statistical Design The Phase I study followed a standard 3+3 dose escalation design. Three dose levels were evaluated. The DLT observation period was the 7-week chemoradiotherapy period and the subsequent 8-week recovery period.
To better study the toxicity at the MTD of the stereotactic boost, there was a 10 patient expansion cohort.The primary endpoint of the phase II portion of the study was two-year local failure rate of the protocol treatment. Local failure was defined as biopsy-proven recurrent disease, or if a biopsy was not attainable, by increasing FDG-avidity on PET-CT on 2 consecutive scans at least 1 month apart. Based on prior studies, a 2-year local failure rate of 15% would be worthy of further study, while a 2-year local failure rate of 35% would not justify further utilization of the treatment. With 32 eligible patients on this study, the treatment will be deemed promising if at least 25 patients are free of local failure at 2 years. Using this design, there was an 8% probability of declaring the treatment worthy of further study if the true 2-year local failure rate was 35%, and a 90% probability of declaring the treatment worthy of further study if the true 2-year local failure rate was 15% by using a one-sided one-sample exact binomial test.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Boost to Chemoradiotherapy (Dose Level 1) | Experimental | Radiation: Stereotactic boost, Radiation: Conventional RT, Drug: Etoposide, Drug: CisplatinChemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 54 Gy; Stereotactic Boost to Primary: 10 Gy; Total Dose to Primary: 64 Gy - Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point. |
| Stereotactic Boost to Chemoradiotherapy (Dose Level 2) | Experimental | Radiation: Stereotactic boost, Radiation: Conventional RT, Drug: Etoposide, Drug: CisplatinChemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 50 Gy; Stereotactic Boost to Primary: 15 Gy; Total Dose to Primary: 65 Gy - Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point. |
| Stereotactic Boost to Chemoradiotherapy (Dose Level 3) | Experimental | Radiation: Stereotactic boost, Radiation: Conventional RT, Drug: Etoposide, Drug: CisplatinChemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 46 Gy; Stereotactic Boost to Primary: 20 Gy; Total Dose to Primary: 66 Gy - Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically confirmed stage II or stage III non-small cell lung cancer, or stage IV non-small cell lung cancer that will be treated with curative intent
- Evaluated by a surgeon and deemed inoperable
- Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as 10mm or greater with chest CT scan.
- No active malignancy within the past 5 years, except for non-melanoma skin cancers or carcinoma in situ of the cervix
- 18 years or older
Key exclusion criteria (11 listed)
- Primary tumor size greater then 6cm
- Prior history of thoracic radiotherapy
- May not be receiving any other study agents
- History of pulmonary fibrosis
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin or etoposide
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 boostAlso: Stereotactic Body Radiotherapy (SBRT) | Radiation | Stereotactic Boost to Chemoradiotherapy (Dose Level 1), Stereotactic Boost to Chemoradiotherapy (Dose Level 2), Stereotactic Boost to Chemoradiotherapy (Dose Level 3) |
| Conventional RT | Radiation | Stereotactic Boost to Chemoradiotherapy (Dose Level 1), Stereotactic Boost to Chemoradiotherapy (Dose Level 2), Stereotactic Boost to Chemoradiotherapy (Dose Level 3) |
| Etoposide | Drug | Stereotactic Boost to Chemoradiotherapy (Dose Level 1), Stereotactic Boost to Chemoradiotherapy (Dose Level 2), Stereotactic Boost to Chemoradiotherapy (Dose Level 3) |
| Cisplatin | Drug | Stereotactic Boost to Chemoradiotherapy (Dose Level 1), Stereotactic Boost to Chemoradiotherapy (Dose Level 2), Stereotactic Boost to Chemoradiotherapy (Dose Level 3) |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 7-week chemoradiotherapy period and the subsequent 8-week recovery period
The MTD is determined by the number of patients who experience a dose limiting toxicity (DLT). The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached. DLTs were defined as follows (CTCAE v4.0): Grade 2 non-hematologic toxicities: Myelitis; Esophageal fistula, perforation, hemorrhage Grade 3 non-hematologic toxicities considered to be a direct result of therapy: Radiation pneumonitis; Pericarditis, pericardial effusion, pericardial tamponade; Esophageal necrosis, stenosis, ulcer; Dyspnea; Myelitis Grade 4 non-hematologic toxicities: Radiation pneumonitis; Pericarditis, pericardial effusion, pericardial tamponade; Esophagitis (not due to mediastinal irradiation unrelated to the stereotactic boost), esophageal necrosis, stenosis, ulcer; Dyspnea; Myelitis Grade 5 non-hematologic toxicity: Any
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Raymond H. Mak, MD principal investigator
Dana-Farber Cancer Institute/Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Stereotactic boost, Conventional RT and Etoposide in people with Non-small Cell Lung Cancer and Lung Cancer, run by Dana-Farber Cancer Institute 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 9 inclusion and 11 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: stopped early, as of the sponsor's last update on 4 Jun 2015. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 5 Sep 2014). 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?
Maximum Tolerated Dose (MTD) (time frame: 7-week chemoradiotherapy period and the subsequent 8-week recovery period). 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 Jun 2015.