Study Stopped
Slow accrual due to restrictive eligibility criteria
Stereotactic Boost for Locally Advanced Non-Small Cell Lung Cancer
1 other identifier
interventional
1
1 country
1
Brief 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 effects the participant experiences; the goal is to improve the likelihood of killing the tumor.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 nonsmall-cell-lung-cancer
Started Dec 2010
Shorter than P25 for phase_1 nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2010
CompletedFirst Posted
Study publicly available on registry
October 18, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
September 5, 2014
CompletedJune 4, 2015
May 1, 2015
1.2 years
October 8, 2010
August 25, 2014
May 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
7-week chemoradiotherapy period and the subsequent 8-week recovery period
Study Arms (3)
Stereotactic Boost to Chemoradiotherapy (Dose Level 1)
EXPERIMENTALChemotherapy: 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)
EXPERIMENTALChemotherapy: 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)
EXPERIMENTALChemotherapy: 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- years or older
- Life expectancy of greater then 6 months
- 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
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Brigham and Women's Hospitalcollaborator
Study Sites (1)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Study was closed due to poor accrual after enrollment of 1 patient and results of trial are not interpretable.
Results Point of Contact
- Title
- Raymond Mak, MD
- Organization
- Dana-Farber Cancer Institute/Brigham and Women's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Raymond H. Mak, MD
Dana-Farber Cancer Institute/Brigham and Women's Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 8, 2010
First Posted
October 18, 2010
Study Start
December 1, 2010
Primary Completion
March 1, 2012
Study Completion
October 1, 2012
Last Updated
June 4, 2015
Results First Posted
September 5, 2014
Record last verified: 2015-05