Nonsmall Cell Lung Cancer, Stage IIPhase 2NCT04398199
Study of Hypofractionated Radiotherapy Alone in Locally Advanced Nonsmall Cell Lung Cancer Patients
A Phase 2 study testing Hypofractionated Radiation Therapy and Radiation Boost in people with Nonsmall Cell Lung Cancer, Stage II and Nonsmall Cell Lung Cancer Stage III, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this research study is to find out what effects (good or bad) may come from a new way of doing radiation therapy for lung cancer. This study is for patients who are not able to get surgery or chemotherapy with their radiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonsmall Cell Lung Cancer, Stage II, Nonsmall Cell Lung Cancer Stage III
- What is being tested?
- Hypofractionated Radiation Therapy and Radiation Boost
- 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
- 16 Oct 2020to 20 Nov 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histological confirmation of non-small cell lung cancer by either biopsy or cytology
- American Joint Committee on Cancer (AJCC) 8th Edition Stage II-III or ultracentral Stage IB disease as determined by PET/CT and MRI Brain
- Ultracentral disease will be defined as edge of gross visible tumor within 1.0 cm of the proximal bronchial tree.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-3
- Participant is not eligible for or has declined surgical resection or stereotactic body radiotherapy as determined by the treating physician
- Participant is not eligible for or has declined concurrent chemotherapy as determined by the treating physician
Show all 9Show fewer
- While investigators expect it to be an uncommon event, sequential use of systemic therapy after completion of radiation therapy is permissible if the participant's status improves such that they become eligible for such therapies, per the discretion of a multidisciplinary tumor board.
- Negative serum or urine pregnancy test within 2 weeks of the date of enrollment for women of child-bearing potential.
- Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
Who cannot join
- History of previous thoracic radiotherapy with the exception of prior radiotherapy for breast cancer without overlap of the fields with the cancer to be treated.
- Prior systemic therapy or surgery for the study cancer.
- Prior malignancy within the past two years except for non-melanoma skin cancer, prostate cancer, or any in-situ malignancy.
- Receipt of anti-angiogenic therapy, such as bevacizumab, within 6 months of enrollment.
- Pregnant women are excluded from this study because radiation therapy has known potential for teratogenic or abortifacient effects.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
About this study
Official title: A Single Arm Phase II Study of Hypofractionated Radiotherapy Alone in Locally Advanced Nonsmall Cell Lung Cancer Patients Who Decline or Are Ineligible for Surgery or Chemotherapy
The purpose of this research study is to find out what effects (good or bad) may come from a new way of doing radiation therapy for lung cancer. This study is for patients who are not able to get surgery or chemotherapy with their radiation. The way of doing radiation therapy in this trial is called hypofractionated radiation therapy which is a standard approach, but this study allows the actual tumor to get an extra radiation dose while still protecting the organs that are near the tumor.
Read the detailed description
Primary Objective:
- To determine the in-field control of hypofractionated radiotherapy consisting of 70 Gy in 25 fractions without concurrent chemotherapy measured at two years after the first post- radiotherapy scan.
Secondary Objective(s):
- To determine the toxicity profile of thoracic hypofractionated radiotherapy consisting of 70 Gy in 25 fractions as graded by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
- To determine proportion with local, regional, and distant progression at 1 and 2 years after the first post-radiotherapy scan, and compute progression-free and overall survival (progression-free survival and overall survival, respectively).
- Being tested
- Hypofractionated Radiation Therapy, Radiation Boost
- 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 Radiation TherapyDrug
The prescribed dose will be 70 Gy in 25 fractions. Participants will radiation therapy once a day for 25 days, Monday through Friday (around 5 weeks).
Radiation BoostRadiation
Undergo simultaneous integrated boost (SIB) to treat both planned target volumes with daily image guidance. This approach allows daily confirmation of target localization and simultaneous delivery of lower dose per fraction to low risk areas while maintaining a high dose per fraction to the highest risk areas.
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated Radiation Therapy | Experimental | Hypofractionated radiation therapy will be delivered to all participants. The radiation will be planned in a special way to give the biggest parts of the tumors that are the most difficult to control a little more radiation every day than the lower risk areas. Receives: Drug: Hypofractionated Radiation Therapy; Radiation: Radiation Boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or Absence of In-Field Progression
In-field progression is defined as growth of the targeted lesions beyond the treated volume. The treated volume will be defined as the 28.75 Gy isodose line (50% of 57.5 Gy). Pathologic confirmation of tumor progression is preferred, but can be determined radiographically by Multidisciplinary Thoracic Oncology Program consensus if biopsy of the lesion in question is not feasible or safe. Investigators will compare the proportion of the sample with any in-field progression at 2 years to the historical control proportion of 0.5, using a one-sample z-test.
Measured: At 2 years
Secondary outcomes (4)
Proportion of Participants Experiencing Grade 2 or Higher Toxicities
Toxicities will be evaluated per Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 constructed with a 95% confidence interval.
Measured: 25 months
Proportion of Participants That Experienced Local Progression
Participants who have experienced local progression by 13 months (1 year following first post-radiotherapy scan) and by 25 months (2 years following first post-radiotherapy scan), and will also compute the same two proportions considering regional progression, distant progression, and any (of the 3 categories) progression. A 95% confidence intervals around these proportions will be constructed. Participants for whom investigators are unable to determine progression status at 1 and 2 years (e.g., because they do not return for the necessary scans, or because they die without evidence of progression) will be left out of these analyses.
Measured: At 1 and 2 years after first post-radiotherapy scan
Progression-Free Survival
Progression-free survival will be evaluated by considering the time from registration to progression of disease or death; those who do not experience either outcome will be censored at date of last visit. Using the Kaplan-Meier lifetable method, and will estimate median survival and corresponding 95% confidence intervals; investigators will also explore simple Cox proportional hazards models of this survival outcomes, to examine the predictive influence of variables such as age, gender, ECOG performance status, stage at diagnosis, planning target volume (PTV) 7000 volume, and planning target volume (PTV) 5750 volume.
Measured: Up to 2 years
Overall Survival
Overall survival will be evaluated by considering the time from registration to death from any cause; those who do not die will be censored at date of last visit. Using the Kaplan-Meier lifetable method, and will estimate median survival and corresponding 95% confidence intervals; investigators will also explore simple Cox proportional hazards models of this survival outcomes, to examine the predictive influence of variables such as age, gender, ECOG performance status, stage at diagnosis, planning target volume (PTV) 7000 volume, and planning target volume (PTV) 5750 volume.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start16 Oct 2020
- Primary completion20 Nov 2020
- Study completion20 Nov 2020
Why it stopped: Low accruals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nonsmall Cell Lung Cancer, Stage IIStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michael Farris, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398199
- Sponsor's protocol ID
- IRB00065905
- Other IDs
- WFBCCC 62220
- Status last verified
- Sep 2022
- First submitted
- 18 May 2020
- Last updated
- 5 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Phase II Study of Hypofractionated Radiotherapy Alone in Locally Advanced Nonsmall Cell Lung Cancer Patients Who Decline or Are Ineligible for Surgery or Chemotherapy
- ClinicalTrials.gov ID
- NCT04398199
- Acronym / sponsor ID
- IRB00065905
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accruals
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 21 May 2020 (actual)
- Results
- Posted 5 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to find out what effects (good or bad) may come from a new way of doing radiation therapy for lung cancer. This study is for patients who are not able to get surgery or chemotherapy with their radiation. The way of doing radiation therapy in this trial is called hypofractionated radiation therapy which is a standard approach, but this study allows the actual tumor to get an extra radiation dose while still protecting the organs that are near the tumor.
Detailed description
Primary Objective:
- To determine the in-field control of hypofractionated radiotherapy consisting of 70 Gy in 25 fractions without concurrent chemotherapy measured at two years after the first post- radiotherapy scan.
Secondary Objective(s):
- To determine the toxicity profile of thoracic hypofractionated radiotherapy consisting of 70 Gy in 25 fractions as graded by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
- To determine proportion with local, regional, and distant progression at 1 and 2 years after the first post-radiotherapy scan, and compute progression-free and overall survival (progression-free survival and overall survival, respectively).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated Radiation Therapy | Experimental | Drug: Hypofractionated Radiation Therapy, Radiation: Radiation BoostHypofractionated radiation therapy will be delivered to all participants. The radiation will be planned in a special way to give the biggest parts of the tumors that are the most difficult to control a little more radiation every day than the lower risk areas. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histological confirmation of non-small cell lung cancer by either biopsy or cytology
- American Joint Committee on Cancer (AJCC) 8th Edition Stage II-III or ultracentral Stage IB disease as determined by PET/CT and MRI Brain
- Ultracentral disease will be defined as edge of gross visible tumor within 1.0 cm of the proximal bronchial tree.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-3
- Participant is not eligible for or has declined surgical resection or stereotactic body radiotherapy as determined by the treating physician
Key exclusion criteria (5 listed)
- History of previous thoracic radiotherapy with the exception of prior radiotherapy for breast cancer without overlap of the fields with the cancer to be treated.
- Prior systemic therapy or surgery for the study cancer.
- Prior malignancy within the past two years except for non-melanoma skin cancer, prostate cancer, or any in-situ malignancy.
- Receipt of anti-angiogenic therapy, such as bevacizumab, within 6 months of enrollment.
- Pregnant women are excluded from this study because radiation therapy has known potential for teratogenic or abortifacient effects.
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 Radiation TherapyThe prescribed dose will be 70 Gy in 25 fractions. Participants will radiation therapy once a day for 25 days, Monday through Friday (around 5 weeks). | Drug | Hypofractionated Radiation Therapy |
| Radiation BoostUndergo simultaneous integrated boost (SIB) to treat both planned target volumes with daily image guidance. This approach allows daily confirmation of target localization and simultaneous delivery of lower dose per fraction to low risk areas while maintaining a high dose per fraction to the highest risk areas. | Radiation | Hypofractionated Radiation Therapy |
Primary outcome
Presence or Absence of In-Field Progression
Time frame: At 2 years
In-field progression is defined as growth of the targeted lesions beyond the treated volume. The treated volume will be defined as the 28.75 Gy isodose line (50% of 57.5 Gy). Pathologic confirmation of tumor progression is preferred, but can be determined radiographically by Multidisciplinary Thoracic Oncology Program consensus if biopsy of the lesion in question is not feasible or safe. Investigators will compare the proportion of the sample with any in-field progression at 2 years to the historical control proportion of 0.5, using a one-sample z-test.
4 secondary outcomes
Proportion of Participants Experiencing Grade 2 or Higher Toxicities
Time frame: 25 months
Proportion of Participants That Experienced Local Progression
Time frame: At 1 and 2 years after first post-radiotherapy scan
Progression-Free Survival
Time frame: Up to 2 years
Overall Survival
Time frame: Up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Michael Farris, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hypofractionated Radiation Therapy and Radiation Boost in people with Nonsmall Cell Lung Cancer, Stage II and Nonsmall Cell Lung Cancer Stage III, run by Wake Forest University Health Sciences 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 9 inclusion and 5 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 5 Oct 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Presence or Absence of In-Field Progression (time frame: At 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 5 Oct 2022.