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Photon Beam Therapy

Photon vs Proton Radiation for Non-Small Cell Lung Cancer

Phase 3
Waitlist Available
Led By Zhongxing Liao
Research Sponsored by Radiation Therapy Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically proven diagnosis of non-small cell lung cancer
Clinical American Joint Committee on Cancer (AJCC) (AJCC, 7th ed.) II, IIIA or IIIB with non-operable disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of treatment to end of follow-up
Awards & highlights
Approved for 10 Other Conditions
No Placebo-Only Group
Pivotal Trial

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.

Who is the study for?
This trial is for adults with stage II-IIIB non-small cell lung cancer that can't be surgically removed. They should have acceptable organ function, no severe illnesses, and not have had certain previous cancer treatments. Women who can bear children must test negative for pregnancy and all participants must agree to use contraception.Check my eligibility
What is being tested?
The study compares two types of radiation therapy (photon vs proton) combined with chemotherapy drugs like paclitaxel and carboplatin to see which is more effective in treating non-operable lung cancer without causing much damage to healthy tissue.See study design
What are the potential side effects?
Possible side effects include fatigue, skin reactions at the treatment site, nausea, hair loss from chemotherapy drugs, as well as potential risks associated with radiation such as inflammation of surrounding organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer diagnosis was confirmed through lab tests.
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My cancer is at stage II, IIIA, or IIIB and cannot be removed by surgery.
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My lung cancer has spread to nearby lymph nodes but the primary tumor can't be found.
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I have chosen not to undergo surgery for my condition.
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My cancer returned after surgery and I am eligible for combined chemotherapy and radiation.
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I've had up to 4 rounds of chemo or 6 months of targeted therapy.
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My cancer has not spread to distant parts of my body.
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I have been mostly active and able to carry on all pre-disease activities without restriction recently.
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My white blood cell count is healthy.
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My kidney function is normal, based on recent tests.
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My nerve damage symptoms are mild or not present.
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I have fluid in my chest that is not caused by cancer.
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I am a woman who can have children and I have a negative pregnancy test from the last 14 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from registration until death or last follow-up; analysis occurs after 390 deaths have been reported
This trial's timeline: 3 weeks for screening, Varies for treatment, and from registration until death or last follow-up; analysis occurs after 390 deaths have been reported for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival
Secondary outcome measures
Adverse events
Progression-free survival

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (proton beam radiation therapy and chemotherapy)Experimental Treatment9 Interventions
Patients undergo proton beam radiation therapy 5 days per week for a total of 35 fractions and receive either paclitaxel* and carboplatin*, etoposide and cisplatin, or pemetrexed and carboplatin (for non-squamous cell cancer patients only) as in Arm I. Patients who receive paclitaxel and carboplatin must complete 2 courses of consolidation therapy. CONSOLIDATION THERAPY: Beginning 3-6 weeks after chemoradiotherapy, patients receive either paclitaxel IV over 3 hours and carboplatin IV on day 1 or durvalumab IV every 2 weeks. Treatment repeats every 21 days for 2 courses or every 2 weeks for up to 12 months for durvalumab in the absence of disease progression or unacceptable toxicity. Patients with non-squamous cell carcinoma may receive durvalumab or pemetrexed IV and carboplatin IV on day 1 every 21 days for up to 4 courses.
Group II: Arm I (photon beam radiation therapy and chemotherapy)Active Control9 Interventions
Patients undergo photon beam radiation therapy 5 days per week for a total of 35 fractions and receive either paclitaxel* IV over 1 hour and carboplatin* IV weekly during radiation therapy or etoposide IV on days 1-5 and 29-33 and cisplatin IV on days 1, 8, 29, and 36. Patients with non-squamous cell cancer may receive pemetrexed IV and carboplatin IV on every 21 days. Patients who receive paclitaxel and carboplatin must complete 2 courses of consolidation therapy. CONSOLIDATION THERAPY: Beginning 3-6 weeks after chemoradiotherapy, patients receive either paclitaxel IV over 3 hours and carboplatin IV on day 1 or durvalumab IV every 2 weeks. Treatment repeats every 21 days for 2 courses or every 2 weeks for up to 12 months for durvalumab in the absence of disease progression or unacceptable toxicity. Patients with non-squamous cell carcinoma may receive durvalumab or pemetrexed IV and carboplatin IV on day 1 every 21 days for up to 4 courses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Proton Beam Radiation Therapy
2013
Completed Phase 2
~110
Etoposide
FDA approved
Paclitaxel
FDA approved
Pemetrexed
FDA approved
Carboplatin
FDA approved
Cisplatin
FDA approved
Durvalumab
FDA approved

Find a Location

Who is running the clinical trial?

Radiation Therapy Oncology GroupLead Sponsor
190 Previous Clinical Trials
64,597 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,565 Previous Clinical Trials
41,223,470 Total Patients Enrolled
NRG OncologyOTHER
230 Previous Clinical Trials
100,324 Total Patients Enrolled

Media Library

Photon Beam Radiation Therapy (Photon Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01993810 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Arm I (photon beam radiation therapy and chemotherapy), Arm II (proton beam radiation therapy and chemotherapy)
Non-Small Cell Lung Cancer Clinical Trial 2023: Photon Beam Radiation Therapy Highlights & Side Effects. Trial Name: NCT01993810 — Phase 3
Photon Beam Radiation Therapy (Photon Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01993810 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does Proton Beam Radiation Therapy have a long and successful history?

"First studied in 1997 at City of Hope Comprehensive Cancer Center, Proton Beam Radiation Therapy has completed 3013 trials as of now. Out of the 2046 active trials, many are conducted in Rockville Centre, New york."

Answered by AI

What types of cancer does Proton Beam Radiation Therapy help to treat?

"Proton Beam Radiation Therapy is commonly used to treat metastatic ureter urothelial carcinoma. It can also be prescribed to treat a variety of other conditions like lymphoma, non-hodgkin, merkel cell cancer, locally advanced non-small cell lung cancer."

Answered by AI

Are there numerous research facilities running this experiment in the United States?

"Right now, this trial is enrolling patients from 20 distinct sites. While some of these locations are in Rockville Centre, Knoxville and Jacksonville, there are many other places where the trial is taking place to make it more accessible for people. If you do decide to participate in the study, try and select a location close to you so that travelling isn't too demanding."

Answered by AI

Is Proton Beam Radiation Therapy a high-risk treatment?

"Proton Beam Radiation Therapy received a score of 3 on our Power safety scale. This is due to the fact that this therapy is in Phase 3 trials, meaning that there is some data supporting both efficacy and safety."

Answered by AI
~23 spots leftby Dec 2024