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Proton Beam Radiation Therapy for Stage IIIB Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Stage IIIB Non-Small Cell Lung Cancer+5 MoreProton Beam Radiation Therapy - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is comparing two types of radiation therapy to see which is more effective in treating patients with stage II-IIIB non-small cell lung cancer- proton chemoradiotherapy versus photon chemoradiotherapy.

Eligible Conditions
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage II Non-Small Cell Lung Cancer
  • Stage III Non-Small Cell Lung Cancer
  • Stage IIA Non-Small Cell Lung Cancer
  • Stage IIB Non-Small Cell Lung Cancer
  • Stage IIIA Non-Small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
Papaverine
1
Radiation Therapy
1
Intensity-Modulated Radiation Therapy

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: From registration to date of local failure, regional failure, distant failure, death from any cause, or until last follow-up. Analysis occurs after 390 deaths have been reported.

From registration to date of local failure, regional failure, distant failure, death from any cause, or until last follow-up. Analysis occurs after 390 deaths have been reported.
Progression-free survival
From registration until death or last follow-up; analysis occurs after 390 deaths have been reported
Overall Survival
From start of treatment to end of follow-up
Adverse events

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Papaverine
2
Radiation Therapy
1
Intensity-Modulated Radiation Therapy

Trial Design

2 Treatment Groups

Arm I (photon beam radiation therapy and chemotherapy)
1 of 2
Arm II (proton beam radiation therapy and chemotherapy)
1 of 2

Active Control

Experimental Treatment

330 Total Participants · 2 Treatment Groups

Primary Treatment: Proton Beam Radiation Therapy · No Placebo Group · Phase 3

Arm II (proton beam radiation therapy and chemotherapy)Experimental Group · 9 Interventions: Quality-of-Life Assessment, Cisplatin, Carboplatin, Proton Beam Radiation Therapy, Questionnaire Administration, Pemetrexed Disodium, Etoposide, Paclitaxel, Durvalumab · Intervention Types: Other, Drug, Drug, Radiation, Other, Drug, Drug, Drug, Biological
Arm I (photon beam radiation therapy and chemotherapy)ActiveComparator Group · 9 Interventions: Quality-of-Life Assessment, Cisplatin, Carboplatin, Questionnaire Administration, Pemetrexed Disodium, Photon Beam Radiation Therapy, Etoposide, Paclitaxel, Durvalumab · Intervention Types: Other, Drug, Drug, Other, Drug, Radiation, Drug, Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chloride ion
Not yet FDA approved
Carboplatin
FDA approved
Proton Beam Radiation Therapy
2013
Completed Phase 2
~50
Pemetrexed
FDA approved
Beta-D-Glucose
Not yet FDA approved
Paclitaxel
FDA approved
Durvalumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from registration to date of local failure, regional failure, distant failure, death from any cause, or until last follow-up. analysis occurs after 390 deaths have been reported.

Who is running the clinical trial?

Radiation Therapy Oncology GroupLead Sponsor
190 Previous Clinical Trials
64,561 Total Patients Enrolled
NRG OncologyOTHER
219 Previous Clinical Trials
95,194 Total Patients Enrolled
1 Trials studying Stage IIIB Non-Small Cell Lung Cancer
170 Patients Enrolled for Stage IIIB Non-Small Cell Lung Cancer
National Cancer Institute (NCI)NIH
13,100 Previous Clinical Trials
41,145,402 Total Patients Enrolled
26 Trials studying Stage IIIB Non-Small Cell Lung Cancer
4,646 Patients Enrolled for Stage IIIB Non-Small Cell Lung Cancer
Zhongxing LiaoPrincipal InvestigatorNRG Oncology
2 Previous Clinical Trials
200 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
) Patients with clinical stage II, IIIA, or IIIB lung cancer (with non-operable disease; non-operable disease will be determined by a multi-disciplinary treatment team within 60 days prior to registration; note: for patients who are clearly nonresectable, the case can be determined by the treating radiation oncologist and/or a medical oncologist or pulmonologist) who are not candidates for surgical resection will be determined to be non-operable.
The student needs to provide a history and physical examination to the school within 30 days prior to registration
A Fludeoxyglucose F 18 (FDG)-positron emission tomography (PET)/computed tomography (CT) scan is done to determine the stage of cancer within 60 days prior to registration for treatment.
An MRI scan or a CT scan with contrast of the brain within 60 days prior to registration is preferred.
for enrollment Patients who have received chemotherapy or targeted therapy are eligible for enrollment.
A diagnosis of non-small cell lung cancer that has been verified through a biopsy or other examination.
You have a primary lung cancer and are 18 years or older.
Patients who refuse surgery are eligible.
for study entry Patients who have a local recurrence after surgery and are candidates for definitive concurrent chemoradiation therapy are eligible for study entry.
The individual has a forced expiratory volume in one second (FEV1) of >= 0.8 liter or >= 35% predicted, which can be confirmed with or without a bronchodilator within 90 days prior to registration.
References

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