Non-small Cell Lung CancerPhase 1HySBstNCT02252796
Phase I Hypofractionated Stereotactic Boost (Radiotherapy) for Non-Small Cell Lung Cancer
A Phase 1 study testing Hypofractionated Stereotactic Boost, Carboplatin and Paclitaxel in people with Non-small Cell Lung Cancer, run by West Virginia University at 1 site in United States.
Trial summary
This study will help researchers test the safety of hypofractionated dose of radiotherapy (HySBst) at different dose levels before or after chemo-radiation for Non Small Cell Lung Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Hypofractionated Stereotactic Boost, Carboplatin and Paclitaxel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Sep 2017
- Phase
- 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
- Stage II - III Non Small Cell Lung Cancer
Who cannot join
- Primary tumor directly invading into any mediastinal structures, such as the heart, major blood vessels, esophagus, trachea, and the proximal bronchial tree.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University Hospitals Mary Babb Randolph Cancer Center
Morgantown, West Virginia, 26506
About this study
Official title: Phase I Dose Escalation Study of a Hypofractionated Stereotactic Boost (HySBst) to the Primary Site in Patients With Stage II-III Non-small Cell Lung Cancer
This study will help researchers test the safety of hypofractionated dose of radiotherapy (HySBst) at different dose levels before or after chemo-radiation for Non Small Cell Lung Cancer.
Read the detailed description
Patients are assigned to Sub-group 1 or 2 based on the primary lesion size and location. This protocol will utilize a standard 3 + 3 phase I design with three patients enrolled per cohort.
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
- Non-small Cell Lung Cancer
- Being tested
- Hypofractionated Stereotactic Boost, Carboplatin, Paclitaxel, Image-guided IMRT
- Keywords
- Non-small Cell Lung Cancer, Radiotherapy Therapy
- 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.
Hypofractionated Stereotactic BoostRadiation
Also called HySBst
An ablative dose of radiation is delivered to the primary tumor target over a week through Stereotactic Ablative Radiotherapy.
CarboplatinDrug
Given during chemo-radiation phase and optional consolidative phase.
PaclitaxelDrug
Given during chemo-radiation phase and optional consolidative phase.
Image-guided IMRTRadiation
Given during chemo-radiation phase
| Study group | Role | What they receive |
|---|---|---|
| Sub-group 1 | Experimental | HySBst to be delivered during week 1 with Chemo-radiation to be delivered weeks 2-7 Receives: Radiation: Hypofractionated Stereotactic Boost; Drug: Carboplatin; Drug: Paclitaxel; Radiation: Image-guided IMRT |
| Sub-group 2 | Experimental | Chemo-radiation to be delivered weeks 1-6 and HySBst to be delivered week 7 Receives: Radiation: Hypofractionated Stereotactic Boost; Drug: Carboplatin; Drug: Paclitaxel; Radiation: Image-guided IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose of HySBst
Measured: 2 years
Secondary outcomes (4)
Dose Limiting Toxicity
Measured: 1 week
Blood Sample Collection
Biomarker analysis
Measured: 2 years
Local Control
To determine the 2-year regional, and distant metastasis rates, progression-free survival (PFS), local progression free survival (L-PFS), overall survival (OS)
Measured: 2 years
Quality of Life
To determine the quality of life before and after treatment using the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 and Lung Cancer 13 (EORTC QLQ-C30, and the LC 13) scales
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2017
- Study completionSep 2017
Why it stopped: Investigator left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malcolm Mattes, MD, Principal investigator, West Virginia University - Mary Babb Randolph Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252796
- Sponsor's protocol ID
- WVU020513
- Acronym
- HySBst
- Status last verified
- May 2018
- First submitted
- 25 Sep 2014
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose Escalation Study of a Hypofractionated Stereotactic Boost (HySBst) to the Primary Site in Patients With Stage II-III Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02252796
- Acronym / sponsor ID
- HySBst / WVU020513
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Non-small Cell Lung Cancer, Radiotherapy Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator left institution
- Enrolment
- 1 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 30 Sep 2014 (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.
This study will help researchers test the safety of hypofractionated dose of radiotherapy (HySBst) at different dose levels before or after chemo-radiation for Non Small Cell Lung Cancer.
Detailed description
Patients are assigned to Sub-group 1 or 2 based on the primary lesion size and location. This protocol will utilize a standard 3 + 3 phase I design with three patients enrolled per cohort.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sub-group 1 | Experimental | Radiation: Hypofractionated Stereotactic Boost, Drug: Carboplatin, Drug: Paclitaxel, Radiation: Image-guided IMRTHySBst to be delivered during week 1 with Chemo-radiation to be delivered weeks 2-7 |
| Sub-group 2 | Experimental | Radiation: Hypofractionated Stereotactic Boost, Drug: Carboplatin, Drug: Paclitaxel, Radiation: Image-guided IMRTChemo-radiation to be delivered weeks 1-6 and HySBst to be delivered week 7 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stage II - III Non Small Cell Lung Cancer
Key exclusion criteria (7 listed)
- Primary tumor directly invading into any mediastinal structures, such as the heart, major blood vessels, esophagus, trachea, and the proximal bronchial tree.
- 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
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 |
|---|---|---|
| Hypofractionated Stereotactic BoostAlso: HySBstAn ablative dose of radiation is delivered to the primary tumor target over a week through Stereotactic Ablative Radiotherapy. | Radiation | Sub-group 1, Sub-group 2 |
| CarboplatinGiven during chemo-radiation phase and optional consolidative phase. | Drug | Sub-group 1, Sub-group 2 |
| PaclitaxelGiven during chemo-radiation phase and optional consolidative phase. | Drug | Sub-group 1, Sub-group 2 |
| Image-guided IMRTGiven during chemo-radiation phase | Radiation | Sub-group 1, Sub-group 2 |
Primary outcome
Maximum Tolerated Dose of HySBst
Time frame: 2 years
4 secondary outcomes
Dose Limiting Toxicity
Time frame: 1 week
Blood Sample Collection
Time frame: 2 years
Local Control
Time frame: 2 years
Quality of Life
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Investigator left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Individual participant dataSharing planned: No
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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.
Malcolm Mattes, MD principal investigator
West Virginia University - Mary Babb Randolph Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hypofractionated Stereotactic Boost, Carboplatin and Paclitaxel in people with Non-small Cell Lung Cancer, run by West Virginia University 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 1 inclusion and 7 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 30 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Investigator left institution). Results are not available in the source record.
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?
Maximum Tolerated Dose of HySBst (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2018.