Hypo-fractionated vs Standard IMRT with Chemotherapy and Immunotherapy for Non-Small Cell Lung Cancer
Recruiting in Palo Alto (17 mi)
+6 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Kansas Medical Center
Must not be taking: Anti-neoplastic, Investigational agents
Disqualifiers: Psychiatric illness, Severe systemic disease, others
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?The hypothesis for this study is that hypofractionated IMRT to 62.5 Gy in 25 fractions (2.5 Gy/fraction) with concurrent carboplatin and paclitaxel, followed by maintenance durvalumab will improve locoregional control at 18 months by 10% compared to standard-fractionated chemo-IMRT/durvalumab. A modest improvement in locoregional control (LRC) was selected as a target which could merit further study of this hypofractionated IMRT regimen in a Phase III trial
Do I need to stop my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, you cannot use other anti-cancer or investigational drugs while participating in this study.
What data supports the effectiveness of the treatment Hypo-Fractionation, Hypofractionated Radiation Therapy, Hypofractionation, HFRT, Standard-Fractionation, Standard-Fractionation Radiation Therapy, Conventional Fractionation Radiation Therapy for Non-Small Cell Lung Cancer?
Research shows that hypofractionated radiation therapy (HFRT) can improve local control and has a higher biological effect with a shorter treatment time for patients with inoperable advanced stage non-small cell lung cancer (NSCLC). Additionally, studies in early-stage breast cancer suggest that HFRT and conventional radiation therapy have equivalent outcomes, indicating potential effectiveness in other cancers as well.
12345Is hypofractionated radiation therapy generally safe for humans?
Research shows that hypofractionated radiation therapy (HFRT) is generally considered safe, with studies in breast cancer patients indicating similar safety profiles to conventional fractionated radiation therapy (CFRT). While specific safety data for non-small cell lung cancer is limited, HFRT has been used safely in other conditions.
13467How is the treatment of hypofractionated radiotherapy with chemotherapy and immunotherapy different for non-small cell lung cancer?
This treatment is unique because it uses hypofractionated radiotherapy (HFRT), which delivers higher doses of radiation over fewer sessions compared to standard fractionation, potentially improving tumor control and survival. It is combined with chemotherapy and immunotherapy, which may enhance the overall effectiveness by targeting cancer cells in multiple ways.
178910Eligibility Criteria
Adults diagnosed with Stage IIIA or IIIB non-small cell lung cancer (NSCLC) who have no brain metastases, negative PET/CT for distant metastasis, and adequate organ function. Women must not be pregnant and agree to contraception. Excluded are those with severe diseases, other treatments, infections, prior thoracic radiotherapy or certain psychiatric/social situations.Inclusion Criteria
Women who could become pregnant must have a negative pregnancy test within one month before starting treatment.
There is no evidence of cancer spread found in the PET/CT scan.
My organ functions are within normal ranges according to recent tests.
+8 more
Exclusion Criteria
I do not have severe health issues that would affect the study.
Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
I am not using, nor plan to use other cancer treatments while in this study.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Radiation and Chemotherapy
Participants receive either hypo-fractionated or standard-fractionated IMRT with concurrent chemotherapy (Paclitaxel and Carboplatin) for 5-6 weeks
5-6 weeks
5 visits per week (in-person)
Immunotherapy
Participants receive maintenance Durvalumab, 1500 mg, IV every 4 weeks for 12 months
12 months
1 visit per month (in-person)
Follow-up
Participants are monitored for safety, effectiveness, and long-term outcomes such as locoregional control, survival, and quality of life
Up to 7.5 years
Participant Groups
The trial is testing if a shorter course of high-dose radiation therapy (hypo-fractionated IMRT) combined with chemotherapy and immunotherapy improves local control of lung cancer compared to the standard longer course (standard-fractionated IMRT), followed by maintenance durvalumab.
2Treatment groups
Experimental Treatment
Active Control
Group I: Hypo-FractionationExperimental Treatment1 Intervention
Participants will receive one fraction of radiation therapy a day for 5 days each week for 5 weeks along with weekly chemotherapy with Paclitaxel 45 milligram per meter squared (mg/m2) through intravenous (IV)infusion for 1 hour followed by Carboplatin area under the curve (AUC) 2 IV for 30 minutes for approximately 5 or 6 weeks. Once complete, participant will receive Durvalumab, 1500 mg, IV every 4 weeks for 12 months.
Group II: Standard-FractionationActive Control1 Intervention
Participants will receive one fraction of radiation therapy a day for 5 days each week for 6 weeks along with weekly chemotherapy with Paclitaxel 45 milligram per meter squared (mg/m2) through intravenous (IV)infusion for 1 hour followed by Carboplatin AUC 2 IV for 30 minutes for approximately 5 or 6 weeks. Once complete, participant will receive Durvalumab, 1500 mg, IV every 4 weeks for 12 months.
Hypo-Fractionation is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Hypofractionated Radiation Therapy for:
- Non-Small Cell Lung Cancer (NSCLC)
🇪🇺 Approved in European Union as Hypofractionated Radiation Therapy for:
- Non-Small Cell Lung Cancer (NSCLC)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of Kansas Cancer Center, North ClinicKansas City, MO
The University of Kansas Medical CenterNorth Kansas City, MO
The University of Kansas Cancer Center, Lee's Summit ClinicLee's Summit, MO
The University of Kansas Cancer Center, Overland Park ClinicOverland Park, KS
More Trial Locations
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Who Is Running the Clinical Trial?
University of Kansas Medical CenterLead Sponsor
References
Utilization and Survival Impact of Hypofractionated Radiotherapy in Stage I Non-small Cell Lung Cancer. [2023]The optimal fractionation schedule in unresected stage I non-small cell lung cancer (NSCLC) unsuitable for stereotactic body radiation therapy is unclear. Given the lack of comparative data regarding nonstereotactic body radiation therapy schemas, we compared overall survival (OS) with hypofractionated radiotherapy (HFRT) versus conventionally fractionated radiotherapy (CFRT) and examined the OS impact of different HFRT doses.
Hypofractionated three-dimensional conformal radiotherapy for medically inoperable early stage non-small-cell lung cancer. [2021]The purpose of this study was to assess the clinical outcomes of hypofractionated radiotherapy (HFRT) with three-dimensional conformal technique for medically inoperable patients with early stage non-small-cell lung cancer (NSCLC) and to evaluate prognostic factors.
Impact of Peer Review on Use of Hypofractionated Regimens for Early-Stage Breast Cancer for Patients at a Tertiary Care Academic Medical Center and Its Community-Based Affiliates. [2020]Data have demonstrated that hypofractionated radiation therapy (HFRT) and conventionally fractionated radiation therapy regimens are equivalent with respect to outcomes. Efforts to increase HFRT use have had mixed success. We implemented a prospective peer review chart rounds integrating all practice sites and reviewed the use of HFRT in an attempt to identify potential predictors of use.
Comparison of Treatment Outcome between Hypofractionated Radiotherapy and Conventional Radiotherapy in Postmastectomy Breast Cancer. [2020]The aim of this study was to compare Conventional fractionated radiotherapy (CFRT) and Hypofractionated radiotherapy (HFRT) in terms of treatment outcomes, such as in 5-year loco-regional recurrence free survival, disease free survival, overall survival, and distant metastatic free survival rates as well as toxicity.
Image guided hypofractionated 3-dimensional radiation therapy in patients with inoperable advanced stage non-small cell lung cancer. [2018]Hypofractionated radiation therapy (HypoRT) can potentially improve local control with a higher biological effect and shorter overall treatment time. Response, local control, toxicity rates, and survival rates were evaluated in patients affected by inoperable advanced stage non-small cell lung cancer (NSCLC) who received HypoRT.
The effect of breast volume on toxicity using hypofractionated regimens for early stage breast cancer for patients. [2022]Hypofractionated radiation therapy (HFRT) remains underused, despite multiple randomized trials showing the equivalence of HFRT to conventional fractionated radiation therapy (CFRT). We sought to retrospectively review the relationship between breast volume and toxicity for HFRT versus CFRT.
Hypo-fractionation radiotherapy normalizes tumor vasculature in non-small cell lung cancer xenografts through the p-STAT3/HIF-1 alpha signaling pathway. [2023]Hypo-fractionation radiotherapy (HFRT) was considered to be an important treatment for non-small cell lung cancer (NSCLC), but the radiobiological effects of HFRT on NSCLC remain unclear. The aim of this study was to investigate specific biological effect of HFRT on tumor angiogenesis, compared with conventional radiotherapy (CRT).
Accelerated hypofractionated radiotherapy plus chemotherapy for inoperable locally advanced non-small-cell lung cancer: final results of a prospective phase-II trial with a long-term follow-up. [2020]Concurrent chemotherapy and radiation using conventional fractionation is the standard treatment for inoperable, locally advanced non-small-cell lung cancer (NSCLC). We tested accelerated hypofractionated radiotherapy (AHR) and chemotherapy for the treatment of locally advanced NSCLC.
Nivolumab and Hypofractionated Radiotherapy in Patients With Advanced Lung Cancer: ABSCOPAL-1 Clinical Trial. [2022]More clinical practice need to be performed to verify the toxicity of the hypofractionated radiotherapy (HFRT) combined with PD-1 blockade in lung cancer. This phase I study aimed to investigate the safety and efficacy of nivolumab combined with HFRT in patients with progressive advanced lung cancer following multiline treatment.
Altered fractionation radiotherapy in lung cancer. [2022]Clinical trials on altered fractionation radiotherapy (RT) regimens currently play a significant role in lung cancer, due to the importance of local control and to the disappointing therapeutic results in this disease. In non-small-cell lung cancer (NSCLC) two strategies are being actively investigated: hyperfractionation with a "curative" aim, and hypofractionation with a palliative aim; in small-cell lung cancer (SCLC) altered fractionation seems to play a minor role at this moment. In this review paper the results of reported randomised trials are summarised and discussed. Conclusions may indicate that through hyperfractionation, particularly if accelerated, clinical outcome of non-metastatic NSCLC patients can be improved; data are however not sufficiently mature to advise its use outside controlled clinical trials. In the palliative setting, hypofractionation should be considered standard treatment.