TerminatedNCT04398199Updated Oct 5, 2022Results posted

Study of Hypofractionated Radiotherapy Alone in Locally Advanced Nonsmall Cell Lung Cancer Patients

A Phase 2 interventional study of Hypofractionated Radiation Therapy and Radiation Boost in Nonsmall Cell Lung Cancer, Stage II and Nonsmall Cell Lung Cancer Stage III, sponsored by Wake Forest University Health Sciences. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-05.

Sponsored by Wake Forest University Health Sciences · Phase 2, Interventional, and Treatment

Why this study was terminated

Low accruals

Phase: Phase 2
Study type: Interventional
Enrollment: 1
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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. 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).

Conditions studied

Nonsmall Cell Lung Cancer, Stage II
Nonsmall Cell Lung Cancer Stage III

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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 1 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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
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).

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 1 participant (actual)

Study arms

Experimental
Hypofractionated Radiation Therapy
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.
Drug: Hypofractionated Radiation Therapy · Radiation: Radiation Boost

Interventions

DrugHypofractionated Radiation Therapy
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).
RadiationRadiation Boost
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.

What researchers measure

Primary outcomes

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.
Time frame: At 2 years

Secondary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 2 years

Results

Posted Oct 5, 2022

Limitations and caveats

One patient was accrued to this trial. He was assigned to the intervention arm. He began on study on 10/16/2020, and began treatment on 10/19/2020. He went off treatment 11/20/2020 due to a fall-he did not return for follow-up after week 3. He expired on 1/8/2021. The study was terminated early due to slow accruals which did not allow enough time for data collection for any outcome measures to properly assess the clinical trial.

Participant flow

Participant flow — Overall Study
Milestone	Hypofractionated Radiation Therapy
Started	1
Completed	1
Not completed	0

Outcome measures

PrimaryPresence 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.

Time frame:: At 2 years