Recurrent Non-small Cell Lung CancerEarly Phase 1NCT01781741

Stereotactic Body Radiation Therapy After Surgery in Treating Patients With Stage III-IV Non-small Cell Lung Cancer

A Early Phase 1 study testing therapeutic lymphadenectomy (TEMLA) and Stereotactic Body radiation therapy (SBRT) and quality-of-life assessment in people with Recurrent Non-small Cell Lung Cancer and Stage IIIA Non-small Cell Lung Cancer, run by Roswell Park Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Recurrent Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer
What is being tested?: therapeutic lymphadenectomy (TEMLA) and Stereotactic Body radiation therapy (SBRT) and quality-of-life assessment
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 6 Mar 2013to 14 Oct 2020
Phase: Early Phase 1
Are there results?: None posted in the registry

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

Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
Have histologically proven diagnosis of non-small cell lung cancer (NSCLC) (stage III and stage IV [to include limited volume metastases such as brain, bone, adrenal])
Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment
Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving and study related procedure
Patients with chemotherapy prior to TEMLA are eligible

Who cannot join

Contraindication to SBRT or TEMLA; this includes the inability to cooperate with any aspect of SBRT such as the inability to lie still and breathe reproducibly
If patient has an open thoracotomy for lung cancer they will not be able to receive SBRT and will be replaced
Pregnant or nursing female patients
Unwilling or unable to follow protocol requirements
Any condition which the investigator's opinion deems the patient ineligible
Received an investigational agent within 30 days prior to enrollment

Trial locations and contacts

1 site in 1 country.

United States1 site

Roswell Park Cancer Institute
Buffalo, New York, 14263

Other trials in United States

About this study

Official title: A Pilot Study of Stereotactic Body Radiation Therapy (SBRT) After TEMLA With or Without Minimally Invasive Surgery for Stage III and Stage IV (Oligometastatic) Non-small Cell Lung Cancer

This pilot clinical trial studies stereotactic body radiation therapy after surgery in treating patients with stage III-IV non-small cell lung cancer. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Lymphadenectomy may remove tumor cells that have spread to nearby lymph nodes in patients with non-small cell lung cancer. Giving stereotactic body radiation therapy after lymphadenectomy may kill any tumor cells that remain after surgery.

Read the detailed description

PRIMARY OBJECTIVES:

To assess the feasibility/toxicity of combining transcervical extended mediastinal lymphadenectomy (TEMLA) with or without video-assisted thoracoscopic surgery (VATS) and stereotactic body radiation therapy (SBRT).

SECONDARY OBJECTIVES:

To assess time to initiation of chemotherapy following TEMLA with or without video-assisted thoracoscopic surgery (VATS)and SBRT.

II. To assess feasibility/toxicity of combining TEMLA with or without VATS and SBRT with various chemotherapy regimens (to be determined by medical oncologist based on patient and tumor characteristics).

III. To estimate survival following TEMLA with or without VATS and SBRT. IV. To define any differences in quality of life/toxicity following TEMLA with or without VATS and SBRT based on tumor location (peripheral/central).

To assess response for primary tumor control and overall survival in TEMLA only patients.

VI. To assess progression free survival for TEMLA with or without (VATS) patients.

OUTLINE:

Patients undergo TEMLA to remove the mediastinal lymph nodes followed by a single fraction of SBRT to the primary tumor (unless VATS procedure done) and mediastinal lymph node beds (if positive on TEMLA), with or without VATS.

After completion of study treatment, patients are followed up at 6,9, and 12 months, every 6 months for 2 years and annually for 2 years.

Conditions: Recurrent Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
Being tested: therapeutic lymphadenectomy (TEMLA) and Stereotactic Body radiation therapy (SBRT), quality-of-life assessment
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.

therapeutic lymphadenectomy (TEMLA) and Stereotactic Body radiation therapy (SBRT)Combination product
Undergo TEMLA and SBRT
quality-of-life assessmentOther
Also called quality of life assessment
Ancillary studies

Study groups in NCT01781741
Study group	Role	What they receive
Treatment (TEMLA and SBRT)	Experimental	Patients undergo TEMLA to remove the mediastinal lymph nodes followed by a single fraction of SBRT to the primary tumor (unless VATS procedure done) and mediastinal lymph node beds (if positive on TEMLA), with or without minimally invasive surgery. Receives: Combination Product: therapeutic lymphadenectomy (TEMLA) and Stereotactic Body radiation therapy (SBRT); Other: quality-of-life assessment

What is being measured

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

Portion of patients with grade 3 or greater toxicity assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4
Toxicity rates will be presented with Clopper-Pearson 90% confidence intervals.
Measured: Up to 3 years

Secondary outcomes (4)

Time until chemotherapy
A 90% confidence interval will be presented.
Measured: From the date of SBRT completion until the date of chemotherapy initiation, assessed up to 5 years
Incidence of toxicity associated with combining TEMLA with or without minimally invasive surgery stratified by chemotherapy regimens
Exact 90% confidence intervals will be obtained for each unique chemotherapy regimen. Will be compared at each time-point between tumor locations using the Fisher's exact test.
Measured: Up to 5 years
Overall survival
Will be described using standard Kaplan-Meier methodologies. The median survival time, 3-year survival rate, and 5-year survival rate and will be estimated and presented with 90% confidence intervals.
Measured: From SBRT completion until death, assessed up to 5 years
Quality of life (QoL) scores from European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and EORTC QLQ Lung Cancer-Specific Module
Will be compared with cumulative toxicity rates at each time-point between tumor locations using the Mann-Whitney U test. Comparisons of QoL scores between time-points will be made using the Wilcoxon signed rank test.
Measured: Up to 5 years

Timeline

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

6 Mar 201314 Oct 2020

First posted1 Feb 2013 (estimated)
Study start6 Mar 2013
Primary completion30 Nov 2015
Study completion14 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Recurrent Non-small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by Roswell Park 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: Early Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01781741
Sponsor's protocol ID: I 223812
Other IDs: NCI-2013-00055, I 223812
Status last verified: Jul 2022
First submitted: 30 Jan 2013
Last updated: 22 Jul 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Singh AK, Hennon M, Ma SJ, Demmy TL, Picone A, Dexter EU, Nwogu C, Attwood K, Tan W, Hermann GM, Fung-Kee-Fung S, Malhotra HK, Yendamuri S, Gomez-Suescun JA. A pilot study of stereotactic body radiation therapy (SBRT) after surgery for stage III non-small cell lung cancer. BMC Cancer. 2018 Nov 29;18(1):1183. doi: 10.1186/s12885-018-5039-5.
PubMed 30497431

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

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study of Stereotactic Body Radiation Therapy (SBRT) After TEMLA With or Without Minimally Invasive Surgery for Stage III and Stage IV (Oligometastatic) Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT01781741
Acronym / sponsor ID: I 223812
Conditions: Recurrent Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Roswell Park Cancer InstituteUniversity, hospital or other
Study start: 6 Mar 2013 (actual)
Primary completion: 30 Nov 2015 (actual)
Study completion: 14 Oct 2020 (actual)
First posted: 1 Feb 2013 (estimated)
Results: Not posted in the source record

Clinical summary

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

Detailed description

PRIMARY OBJECTIVES:

To assess the feasibility/toxicity of combining transcervical extended mediastinal lymphadenectomy (TEMLA) with or without video-assisted thoracoscopic surgery (VATS) and stereotactic body radiation therapy (SBRT).

SECONDARY OBJECTIVES:

To assess time to initiation of chemotherapy following TEMLA with or without video-assisted thoracoscopic surgery (VATS)and SBRT.

To assess response for primary tumor control and overall survival in TEMLA only patients.

VI. To assess progression free survival for TEMLA with or without (VATS) patients.

OUTLINE:

After completion of study treatment, patients are followed up at 6,9, and 12 months, every 6 months for 2 years and annually for 2 years.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (TEMLA and SBRT)	Experimental	Combination Product: therapeutic lymphadenectomy (TEMLA) and Stereotactic Body radiation therapy (SBRT), Other: quality-of-life assessmentPatients undergo TEMLA to remove the mediastinal lymph nodes followed by a single fraction of SBRT to the primary tumor (unless VATS procedure done) and mediastinal lymph node beds (if positive on TEMLA), with or without minimally invasive surgery.

Who may qualify

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

Key inclusion criteria (5 listed)

Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
Have histologically proven diagnosis of non-small cell lung cancer (NSCLC) (stage III and stage IV [to include limited volume metastases such as brain, bone, adrenal])
Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment
Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving and study related procedure
Patients with chemotherapy prior to TEMLA are eligible

Key exclusion criteria (6 listed)

Contraindication to SBRT or TEMLA; this includes the inability to cooperate with any aspect of SBRT such as the inability to lie still and breathe reproducibly
If patient has an open thoracotomy for lung cancer they will not be able to receive SBRT and will be replaced
Pregnant or nursing female patients
Unwilling or unable to follow protocol requirements
Any condition which the investigator's opinion deems the patient ineligible

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
therapeutic lymphadenectomy (TEMLA) and Stereotactic Body radiation therapy (SBRT)Undergo TEMLA and SBRT	Combination product	Treatment (TEMLA and SBRT)
quality-of-life assessmentAlso: quality of life assessmentAncillary studies	Other	Treatment (TEMLA and SBRT)

Primary outcome

Portion of patients with grade 3 or greater toxicity assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4
Time frame: Up to 3 years
Toxicity rates will be presented with Clopper-Pearson 90% confidence intervals.

4 secondary outcomes

Time until chemotherapy
Time frame: From the date of SBRT completion until the date of chemotherapy initiation, assessed up to 5 years
Incidence of toxicity associated with combining TEMLA with or without minimally invasive surgery stratified by chemotherapy regimens
Time frame: Up to 5 years
Overall survival
Time frame: From SBRT completion until death, assessed up to 5 years
Quality of life (QoL) scores from European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and EORTC QLQ Lung Cancer-Specific Module
Time frame: Up to 5 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
Derived from this study: PubMed 30497431Singh AK, Hennon M, Ma SJ, Demmy TL, Picone A, Dexter EU, Nwogu C, Attwood K, Tan W, Hermann GM, Fung-Kee-Fung S, Malhotra HK, Yendamuri S, Gomez-Suescun JA. A pilot study of stereotactic body radiation therapy (SBRT) after surgery for stage III non-small cell lung cancer. BMC Cancer. 2018 Nov 29;18(1):1183. doi: 10.1186/s12885-018-5039-5.

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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.

Anurag Singh principal investigator

Roswell Park Cancer Institute

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

Questions about this trial

What is this clinical trial studying?

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 5 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 22 Jul 2022. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Portion of patients with grade 3 or greater toxicity assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4 (time frame: Up to 3 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 NCT01781741, 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 22 Jul 2022.