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

NCT04398199 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: IRB00065905WFBCCC 62220
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  At 2 years

Secondary Outcomes (4)

• Proportion of Participants Experiencing Grade 2 or Higher Toxicities

  25 months

• Proportion of Participants That Experienced Local Progression

  At 1 and 2 years after first post-radiotherapy scan

• Progression-Free Survival

  Up to 2 years

• Overall Survival

  Up to 2 years

Study Arms (1)

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.

Drug: Hypofractionated Radiation Therapy; Radiation: Radiation Boost

Interventions

Hypofractionated Radiation Therapy DRUG

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).

Hypofractionated Radiation Therapy

Radiation Boost RADIATION

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.

Hypofractionated Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

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.

Results Point of Contact

• Title: Principal Investigator
• Organization: Wake Forest Baptist Comprehensive Cancer Center

mfarris@wakehealth.edu

336-713-5440

Study Officials

• Michael Farris, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 21, 2020
• Study Start: October 16, 2020
• Primary Completion: November 20, 2020
• Study Completion: November 20, 2020
• Last Updated: October 5, 2022
• Results First Posted: October 5, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)