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

Primary Purpose

Lung Cancer

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

computed tomography

fludeoxyglucose F 18

hypofractionated radiation therapy

stereotactic radiosurgery

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage I non-small cell lung cancer, stage II non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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"
- 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

Exclusion Criteria:

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)

Sites / Locations

Boston University Cancer Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

56 Gray (LESS than 3 centimeter cohort)

62 Gray (LESS than 3 centimeter cohort)

68 Gray (LESS than 3 centimeter cohort)

56 Gray (MORE than 3 centimeter cohort)

62 Gray (MORE than 3 centimeter cohort)

68 Gray (MORE than 3 centimeter cohort)

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

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

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.

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

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00852644

First Posted

February 26, 2009

Last Updated

April 11, 2018

Sponsor

Boston Medical Center

Collaborators

United States Department of Defense

1. Study Identification

Unique Protocol Identification Number

NCT00852644

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Terminated

Why Stopped

poor accrual

Study Start Date

January 2009 (Actual)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Boston Medical Center

Collaborators

United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

stage I non-small cell lung cancer, stage II non-small cell lung cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

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)

Allocation

Non-Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

56 Gray (LESS than 3 centimeter cohort)

Arm Type

Experimental

Arm Description

Arm Title

62 Gray (LESS than 3 centimeter cohort)

Arm Type

Experimental

Arm Description

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

Arm Title

68 Gray (LESS than 3 centimeter cohort)

Arm Type

Experimental

Arm Description

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

Arm Title

56 Gray (MORE than 3 centimeter cohort)

Arm Type

Experimental

Arm Description

Arm Title

62 Gray (MORE than 3 centimeter cohort)

Arm Type

Experimental

Arm Description

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

Arm Title

68 Gray (MORE than 3 centimeter cohort)

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

computed tomography

Intervention Description

Standard CT scans

Intervention Type

Radiation

Intervention Name(s)

fludeoxyglucose F 18

Intervention Description

standard doses with CT scans

Intervention Type

Radiation

Intervention Name(s)

hypofractionated radiation therapy

Intervention Description

4 doses over 2 weeks

Intervention Type

Radiation

Intervention Name(s)

stereotactic radiosurgery

Intervention Description

CyberKnife radiosurgery

Primary Outcome Measure Information:

Title

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

Description

Number of Participants Who Did Not Experience a Dose Limiting Toxicity in the less than 3 centimeter cohort

Time Frame

6 weeks

Title

Maximum Tolerated Dose in the Less Than 3 Centimeter Cohort

Description

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

Time Frame

6 weeks

Title

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

Description

The number of participants that did not experience a dose-limiting toxicity in the greater than 3 centimeter cohort

Time Frame

6 weeks

Title

Maximum Tolerated Dose - More Than 3 Centimeter Cohort.

Description

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

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Relationship Between Positron Emission Tomography (PET) Response and Local Control and Survival

Description

Relationship between positron emission tomography (PET) response and local control and survival as measured by fludeoxyglucose F 18 PET/CT imaging

Time Frame

before treatment and at 1, 3, 6, and 12 months after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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" 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 Exclusion Criteria: 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Minh Tam Truong, MD

Organizational Affiliation

Boston Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Boston University Cancer Research Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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