Phase I Hypofractionated Stereotactic Boost (Radiotherapy) for Non-Small Cell Lung Cancer
NCT ID: NCT02252796
Last Updated: 2018-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
1 participants
INTERVENTIONAL
2014-07-31
2017-09-30
Brief Summary
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Detailed Description
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Patients will be offered the opportunity to participate in the blood specimen component of the study.
Patients will be followed up to 2 years post radiation therapy.
Sub-group 1 will receive HySBst for 1 week. Weeks 2-7 will be standard chemo-radiation therapy. Patients have the option of consolidative chemotherapy at week 12.
Sub-group 2 will receive standard chemo-radiation therapy for weeks 1-6 then receive HySBst during week 7. Patients have the option of consolidative chemotherapy at week 12.
HySBst dose escalation for each sub-group is listed below:
Optional: 4 Gy x 4 daily fractions Level 1: 5 Gy x 4 daily fractions Level 2: 5.5 Gy x 4 daily fractions Level 3: 6 Gy x 4 daily fractions
DLTs will be based on events occurring during the course of HySBst.
Chemo-Radiation Therapy is defined as:
Standard Carboplatin \& Paclitaxel Doublelet Regimen with weekly Carboplatin AUC 2/week and Paclitaxel 45 mg/ m2/ week during conventionally fractionated IMRT
Image-guided IMRT to 60 Gy, 5 x per week for 6 weeks
Consolidative chemotherapy is defined as Carboplatin AUC 6 and Paclitaxel 200 mg/m2 every 21 days x 2 cycles will be given after ALL radiotherapy is delivered.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sub-group 1
HySBst to be delivered during week 1 with Chemo-radiation to be delivered weeks 2-7
Hypofractionated Stereotactic Boost
An ablative dose of radiation is delivered to the primary tumor target over a week through Stereotactic Ablative Radiotherapy.
Carboplatin
Given during chemo-radiation phase and optional consolidative phase.
Paclitaxel
Given during chemo-radiation phase and optional consolidative phase.
Image-guided IMRT
Given during chemo-radiation phase
Sub-group 2
Chemo-radiation to be delivered weeks 1-6 and HySBst to be delivered week 7
Hypofractionated Stereotactic Boost
An ablative dose of radiation is delivered to the primary tumor target over a week through Stereotactic Ablative Radiotherapy.
Carboplatin
Given during chemo-radiation phase and optional consolidative phase.
Paclitaxel
Given during chemo-radiation phase and optional consolidative phase.
Image-guided IMRT
Given during chemo-radiation phase
Interventions
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Hypofractionated Stereotactic Boost
An ablative dose of radiation is delivered to the primary tumor target over a week through Stereotactic Ablative Radiotherapy.
Carboplatin
Given during chemo-radiation phase and optional consolidative phase.
Paclitaxel
Given during chemo-radiation phase and optional consolidative phase.
Image-guided IMRT
Given during chemo-radiation phase
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Prior chemotherapy for NSCLC
* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
* Severe, active co-morbidity
* Pregnancy or women of childbearing potential
* Any history of allergic reaction to paclitaxel or other taxanes, or to carboplatin
* Uncontrolled neuropathy ≥ grade 2.
18 Years
ALL
No
Sponsors
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West Virginia University
OTHER
Responsible Party
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Principal Investigators
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Malcolm Mattes, MD
Role: PRINCIPAL_INVESTIGATOR
West Virginia University - Mary Babb Randolph Cancer Center
Locations
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West Virginia University Hospitals Mary Babb Randolph Cancer Center
Morgantown, West Virginia, United States
Countries
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Other Identifiers
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WVU020513
Identifier Type: -
Identifier Source: org_study_id
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