Lung CancerNCT00852644

Stereotactic Radiosurgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer

A study testing computed tomography, fludeoxyglucose F 18 and hypofractionated radiation therapy in people with Lung Cancer, run by Boston Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with stage I or stage II non-small cell lung cancer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Cancer
What is being tested?: computed tomography, fludeoxyglucose F 18 and hypofractionated radiation therapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteUnited States
Study dates: Jan 2009to Aug 2016
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer
Stage I or II disease (T1-3, N0, M0)
T2 or T3 tumor ≤ 5 cm
No T3 tumors involving the central chest or mediastinum (only chest wall involvement allowed)
Tumor deemed technically resectable, in the opinion of an experienced thoracic surgeon, AND patient deemed "medically inoperable"

Show all 11Show fewer

Patients with fluorodeoxyglucose (FDG)-avidity in mediastinal lymph nodes are eligible provided they are able to undergo mediastinoscopy to confirm N0 status
PATIENT CHARACTERISTICS:
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Not pregnant or nursing
Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment

Who cannot join

No history of contrast allergy
No psychological issues that would preclude the completion of study treatment
PRIOR CONCURRENT THERAPY:
No prior radiotherapy or chemotherapy
No suspected nodal metastasis that cannot be falsified by mediastinoscopy (i.e., hilar or mediastinal nodes that are either fludeoxyglucose F 18 [FDG]-avid or measure > 1 cm in short axis diameter on CT scan)
No tumor within or touching the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (carina, right and left main stem bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)

Trial locations and contacts

1 site in 1 country.

United States1 site

Boston University Cancer Research Center
Boston, Massachusetts, 02118

Other trials in United States

About this study

Official title: Feasibility and Outcome of Cyberknife® Precision Hypofractionated Radiosurgery for the Curative Management of Non-Small Cell Lung Cancer

RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with stage I or stage II non-small cell lung cancer.

Read the detailed description

OBJECTIVES:

To establish the maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery in patients with medically inoperable, stage I or II non-small cell lung cancer.
To establish the relationship between positron emission tomography (PET) response and local control and survival using fludeoxyglucose F 18 PET/CT imaging before treatment and at 1, 3, 6, and 12 months after treatment.

OUTLINE: Patients undergo placement of 3 gold fiducial markers by CT-guidance or bronchoscopy. Patients then undergo CyberKnife® hypofractionated stereotactic radiosurgery over 45-120 minutes twice weekly for 2 weeks.

Patients undergo fludeoxyglucose F 18 PET/CT scan at baseline and at 1, 3, 6, and 12 months after completion of treatment.

After completion of study treatment, patients are followed periodically for up to 4 years.

Conditions: Lung Cancer
Being tested: computed tomography, fludeoxyglucose F 18, hypofractionated radiation therapy, stereotactic radiosurgery
Keywords: stage I non-small cell lung cancer, stage II non-small cell lung cancer
Medical subject headings: Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

computed tomographyProcedure or surgery
Standard CT scans
fludeoxyglucose F 18Radiation
standard doses with CT scans
hypofractionated radiation therapyRadiation
4 doses over 2 weeks
stereotactic radiosurgeryRadiation
CyberKnife radiosurgery

Study groups in NCT00852644
Study group	Role	What they receive
56 Gray (LESS than 3 centimeter cohort)	Experimental	Intervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery Receives: Procedure: computed tomography; Radiation: fludeoxyglucose F 18; Radiation: hypofractionated radiation therapy; Radiation: stereotactic radiosurgery
62 Gray (LESS than 3 centimeter cohort)	Experimental	Intervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery Receives: Procedure: computed tomography; Radiation: fludeoxyglucose F 18; Radiation: hypofractionated radiation therapy; Radiation: stereotactic radiosurgery
68 Gray (LESS than 3 centimeter cohort)	Experimental	Intervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery Receives: Procedure: computed tomography; Radiation: fludeoxyglucose F 18; Radiation: hypofractionated radiation therapy; Radiation: stereotactic radiosurgery
56 Gray (MORE than 3 centimeter cohort)	Experimental	Intervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery Receives: Procedure: computed tomography; Radiation: fludeoxyglucose F 18; Radiation: hypofractionated radiation therapy; Radiation: stereotactic radiosurgery
62 Gray (MORE than 3 centimeter cohort)	Experimental	Intervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery Receives: Procedure: computed tomography; Radiation: fludeoxyglucose F 18; Radiation: hypofractionated radiation therapy; Radiation: stereotactic radiosurgery
68 Gray (MORE than 3 centimeter cohort)	Experimental	Intervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery Receives: Procedure: computed tomography; Radiation: fludeoxyglucose F 18; Radiation: hypofractionated radiation therapy; Radiation: stereotactic radiosurgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Participants Who Did Not Experience a Dose Limiting Toxicity in the Less Than 3 Centimeter Cohort
Number of Participants Who Did Not Experience a Dose Limiting Toxicity in the less than 3 centimeter cohort
Measured: 6 weeks
Maximum Tolerated Dose in the Less Than 3 Centimeter Cohort
The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.
Measured: 6 weeks
Participants Who Did Not Experience a Dose Limiting Toxicity in the More Than 3 Centimeter Cohort
The number of participants that did not experience a dose-limiting toxicity in the greater than 3 centimeter cohort
Measured: 6 weeks
Maximum Tolerated Dose - More Than 3 Centimeter Cohort.
The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.
Measured: 6 weeks

Secondary outcomes (1)

Relationship Between Positron Emission Tomography (PET) Response and Local Control and Survival
Relationship between positron emission tomography (PET) response and local control and survival as measured by fludeoxyglucose F 18 PET/CT imaging
Measured: before treatment and at 1, 3, 6, and 12 months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009Aug 2016

First posted27 Feb 2009 (estimated)
Study startJan 2009
Primary completionJun 2013
Study completionAug 2016

Why it stopped: poor accrual

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 Lung CancerStudies of the same condition, open and under way.
More trials run by Boston 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
Model description: Participants to receive Cyberknife radiation therapy in 4 doses over two weeks. Dose will be determined using a dose-escalation plan.
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00852644
Sponsor's protocol ID: H-26701
Other IDs: CDR0000635119
Status last verified: Apr 2018
First submitted: 26 Feb 2009
Last updated: 11 May 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer

All Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility and Outcome of Cyberknife® Precision Hypofractionated Radiosurgery for the Curative Management of Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT00852644
Acronym / sponsor ID: H-26701
Conditions: Lung Cancer
Keywords: stage I non-small cell lung cancer, stage II non-small cell lung cancer
Study type: Interventional
Recruitment status: TerminatedReason stopped: poor accrual
Enrolment: 9 participants (actual)
Lead sponsor: Boston Medical CenterUniversity, hospital or other
Collaborators: United States Department of Defense
Study start: Jan 2009 (actual)
Primary completion: Jun 2013 (actual)
Study completion: Aug 2016 (actual)
First posted: 27 Feb 2009 (estimated)
Results: Posted 9 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with stage I or stage II non-small cell lung cancer.

Detailed description

OBJECTIVES:

To establish the maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery in patients with medically inoperable, stage I or II non-small cell lung cancer.
To establish the relationship between positron emission tomography (PET) response and local control and survival using fludeoxyglucose F 18 PET/CT imaging before treatment and at 1, 3, 6, and 12 months after treatment.

Patients undergo fludeoxyglucose F 18 PET/CT scan at baseline and at 1, 3, 6, and 12 months after completion of treatment.

After completion of study treatment, patients are followed periodically for up to 4 years.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 6
Model description: Participants to receive Cyberknife radiation therapy in 4 doses over two weeks. Dose will be determined using a dose-escalation plan.

Arm	Type	Receives
56 Gray (LESS than 3 centimeter cohort)	Experimental	Procedure: computed tomography, Radiation: fludeoxyglucose F 18, Radiation: hypofractionated radiation therapy, Radiation: stereotactic radiosurgeryIntervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery
62 Gray (LESS than 3 centimeter cohort)	Experimental	Procedure: computed tomography, Radiation: fludeoxyglucose F 18, Radiation: hypofractionated radiation therapy, Radiation: stereotactic radiosurgeryIntervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery
68 Gray (LESS than 3 centimeter cohort)	Experimental	Procedure: computed tomography, Radiation: fludeoxyglucose F 18, Radiation: hypofractionated radiation therapy, Radiation: stereotactic radiosurgeryIntervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery
56 Gray (MORE than 3 centimeter cohort)	Experimental	Procedure: computed tomography, Radiation: fludeoxyglucose F 18, Radiation: hypofractionated radiation therapy, Radiation: stereotactic radiosurgeryIntervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery
62 Gray (MORE than 3 centimeter cohort)	Experimental	Procedure: computed tomography, Radiation: fludeoxyglucose F 18, Radiation: hypofractionated radiation therapy, Radiation: stereotactic radiosurgeryIntervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery
68 Gray (MORE than 3 centimeter cohort)	Experimental	Procedure: computed tomography, Radiation: fludeoxyglucose F 18, Radiation: hypofractionated radiation therapy, Radiation: stereotactic radiosurgeryIntervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Histologically confirmed non-small cell lung cancer
Tumor deemed technically resectable, in the opinion of an experienced thoracic surgeon, AND patient deemed "medically inoperable"
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Not pregnant or nursing
Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment

Key exclusion criteria (6 listed)

No history of contrast allergy
No psychological issues that would preclude the completion of study treatment
No prior radiotherapy or chemotherapy
No suspected nodal metastasis that cannot be falsified by mediastinoscopy (i.e., hilar or mediastinal nodes that are either fludeoxyglucose F 18 [FDG]-avid or measure > 1 cm in short axis diameter on CT scan)
No tumor within or touching the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (carina, right and left main stem bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)

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
computed tomographyStandard CT scans	Procedure or surgery	56 Gray (LESS than 3 centimeter cohort), 56 Gray (MORE than 3 centimeter cohort), 62 Gray (LESS than 3 centimeter cohort), 62 Gray (MORE than 3 centimeter cohort), 68 Gray (LESS than 3 centimeter cohort), 68 Gray (MORE than 3 centimeter cohort)
fludeoxyglucose F 18standard doses with CT scans	Radiation	56 Gray (LESS than 3 centimeter cohort), 56 Gray (MORE than 3 centimeter cohort), 62 Gray (LESS than 3 centimeter cohort), 62 Gray (MORE than 3 centimeter cohort), 68 Gray (LESS than 3 centimeter cohort), 68 Gray (MORE than 3 centimeter cohort)
hypofractionated radiation therapy4 doses over 2 weeks	Radiation	56 Gray (LESS than 3 centimeter cohort), 56 Gray (MORE than 3 centimeter cohort), 62 Gray (LESS than 3 centimeter cohort), 62 Gray (MORE than 3 centimeter cohort), 68 Gray (LESS than 3 centimeter cohort), 68 Gray (MORE than 3 centimeter cohort)
stereotactic radiosurgeryCyberKnife radiosurgery	Radiation	56 Gray (LESS than 3 centimeter cohort), 56 Gray (MORE than 3 centimeter cohort), 62 Gray (LESS than 3 centimeter cohort), 62 Gray (MORE than 3 centimeter cohort), 68 Gray (LESS than 3 centimeter cohort), 68 Gray (MORE than 3 centimeter cohort)

Primary outcome

Participants Who Did Not Experience a Dose Limiting Toxicity in the Less Than 3 Centimeter Cohort
Time frame: 6 weeks
Number of Participants Who Did Not Experience a Dose Limiting Toxicity in the less than 3 centimeter cohort
Maximum Tolerated Dose in the Less Than 3 Centimeter Cohort
Time frame: 6 weeks
The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.
Participants Who Did Not Experience a Dose Limiting Toxicity in the More Than 3 Centimeter Cohort
Time frame: 6 weeks
The number of participants that did not experience a dose-limiting toxicity in the greater than 3 centimeter cohort
Maximum Tolerated Dose - More Than 3 Centimeter Cohort.
Time frame: 6 weeks
The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.

1 secondary outcome

Relationship Between Positron Emission Tomography (PET) Response and Local Control and Survival
Time frame: before treatment and at 1, 3, 6, and 12 months after treatment

Results and safety

Results posted to the registry on 9 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
56 Gray (LESS Than 3 Centimeter Cohort)	3	3
62 Gray (LESS Than 3 Centimeter Cohort)	3	3
68 Gray (LESS Than 3 Centimeter Cohort)	0	0
56 Gray (MORE Than 3 Centimeter Cohort)	3	3
62 Gray (MORE Than 3 Centimeter Cohort)	0	0
68 Gray (MORE Than 3 Centimeter Cohort)	0	0

Primary outcome: Participants Who Did Not Experience a Dose Limiting Toxicity in the Less Than 3 Centimeter Cohort

Time frame: 6 weeks. Count of participants. Unit: Participants

Measure	56 Gray (LESS Than 3 Centimeter Cohort) n = 3	62 Gray (LESS Less Than 3 Centimeter Cohort) n = 3	68 Gray (LESS Than 3 Centimeter Cohort) n = 0
Value	3	3	0

Primary outcome: Maximum Tolerated Dose in the Less Than 3 Centimeter Cohort

Time frame: 6 weeks

Population analysed: The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.

Primary outcome: Participants Who Did Not Experience a Dose Limiting Toxicity in the More Than 3 Centimeter Cohort

Time frame: 6 weeks. Count of participants. Unit: Participants

Measure	56 Gray (MORE Than 3 Centimeter Cohort) n = 3	62 Gray (MORE Than 3 Centimeter Cohort) n = 0	68 Gray (MORE Than 3 Centimeter Cohort) n = 0
Value	3	0	0

Primary outcome: Maximum Tolerated Dose - More Than 3 Centimeter Cohort.

Time frame: 6 weeks

Population analysed: The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
56 Gray (LESS Than 3 Centimeter Cohort)	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
62 Gray (LESS Than 3 Centimeter Cohort)	2 of 3 (66.7%)	3 of 3 (100%)	0 of 3
68 Gray (LESS Than 3 Centimeter Cohort)	0 of 0	0 of 0	0
56 Gray (MORE Than 3 Centimeter Cohort)	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
62 Gray (MORE Than 3 Centimeter Cohort)	0 of 0	0 of 0	0
68 Gray (MORE Than 3 Centimeter Cohort)	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): The highest tolerable dose was not established in either cohort due to early termination. There were no dose limiting toxicities experienced at 56 or 62 gray (less than 3 centimeters) or 56 gray (more than 3 centimeters) at the time of study closure

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Lung Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer

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.

Minh Tam Truong, MD principal investigator

Boston Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing computed tomography, fludeoxyglucose F 18 and hypofractionated radiation therapy in people with Lung Cancer, run by Boston 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 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: stopped early, as of the sponsor's last update on 11 May 2018. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jan 2018). 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?

Participants Who Did Not Experience a Dose Limiting Toxicity in the Less Than 3 Centimeter Cohort (time frame: 6 weeks). The study lists 4 primary outcomes in all. 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 NCT00852644.

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 11 May 2018.