Radiation therapy for Stage IIB Non-small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Washington University School of Medicine, Saint Louis, MOStage IIB Non-small Cell Lung Cancer+3 MoreRadiation therapy - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a new approach to treating lung cancer that uses both radiation and immunotherapy.

Eligible Conditions
  • Stage IIB Non-small Cell Lung Cancer
  • Stage IIIA Non-small Cell Lung Cancer
  • Non-small Cell Lung Cancer Stage IIIB
  • Stage IIIC Non-Small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Papaverine
1
Palliative Radiation Therapy
1
Radiation: Varying Doses of RT

Study Objectives

4 Primary · 8 Secondary · Reporting Duration: From 61 days after start of chemoradiation through 2 years after the start of chemoradiation

Year 2
Number of late toxicities
Day 60
Acute Coryza
Year 2
Disease
Distant recurrence rate
Incidence of brain metastases
Local control rate (Phase II only)
Overall survival
Progression-free survival (PFS)
Regional control rate (Phase II only)
Month 6
Safety lead-in only: Number of participants with dose limiting toxicities (DLTs)
Month 12
Tumor response rate
Up to 24 months
Local and/or regional control rate (Phase II only)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Papaverine
1
Palliative Radiation Therapy
1
Radiation: Varying Doses of RT

Side Effects for

Hormones and RT
78%Menopausal symptoms
60%Urinary frequency
52%Impotence
47%Late RT Toxicity: Bladder: NOS
39%Diarrhea NOS
27%Late RT Toxicity: Bowel: NOS
26%Late RT Toxicity: Other GU: NOS
26%Fatigue
21%Proctitis NOS
21%Dysuria
14%Libido decreased
14%Dermatitis radiation NOS
12%Late RT Toxicity: Other GI: NOS
12%Hemoglobin decreased
12%Late RT Toxicity: Other: NOS
12%Alanine aminotransferase increased
9%Gynaecomastia
8%Urinary retention
7%Aspartate aminotransferase increased
7%Pain-other
6%Constipation
6%Leukopenia NOS
6%Rectal bleeding
4%Hematuria present
4%Renal/GU-Other
4%Edema NOS
3%Arthralgia
3%Dyspnea NOS
3%Dermatitis exfoliative NOS
3%Blood creatinine increased
2%Peripheral sensory neuropathy
2%Myalgia
2%Hyperglycemia NOS
2%Depression NEC
2%Lymphopenia
2%Nausea
1%Blood albumin decreased
1%Hypocalcemia
1%Hyponatremia
1%Weight decreased
1%Alopecia
1%Platelet count decreased
1%Neutropenia
1%Stomatitis
1%Hematologic-Other
1%Anorexia
This histogram enumerates side effects from a completed 2013 Phase 3 trial (NCT00004054) in the Hormones and RT ARM group. Side effects include: Menopausal symptoms with 78%, Urinary frequency with 60%, Impotence with 52%, Late RT Toxicity: Bladder: NOS with 47%, Diarrhea NOS with 39%.

Trial Design

2 Treatment Groups

Safety lead-in: Chemoradiation + Durvalumab
1 of 2
Phase II: Chemoradiation + Durvalumab
1 of 2

Experimental Treatment

27 Total Participants · 2 Treatment Groups

Primary Treatment: Radiation therapy · No Placebo Group · Phase 2

Safety lead-in: Chemoradiation + DurvalumabExperimental Group · 5 Interventions: Paclitaxel, Durvalumab, Carboplatin AUC, ViewRay MR-Linear Accelerator, Radiation therapy · Intervention Types: Drug, Biological, Drug, Device, Radiation
Phase II: Chemoradiation + DurvalumabExperimental Group · 5 Interventions: Paclitaxel, Durvalumab, Carboplatin AUC, ViewRay MR-Linear Accelerator, Radiation therapy · Intervention Types: Drug, Biological, Drug, Device, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Durvalumab
FDA approved
Carboplatin
FDA approved
Radiation therapy
2013
Completed Phase 3
~2840

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from 61 days after start of chemoradiation through 2 years after the start of chemoradiation

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,822 Previous Clinical Trials
2,283,981 Total Patients Enrolled
Gregory Vlacich, M.D, Ph.D.Principal InvestigatorWashington University School of Medicine

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a certain stage of cancer (T3-4N3M0) but are still eligible if the cancer has only spread to a limited number of lymph node stations and the tumor is only large due to its size.
References

Frequently Asked Questions

Are there any openings for participants of this research currently available?

"According to clinicaltrials.gov, this research project is currently recruiting participants. It was initially introduced on June 20th 2019 and its details were most recently refreshed on June 27th 2022." - Anonymous Online Contributor

Unverified Answer

What medical conditions are commonly treated with Radiation therapy?

"Radiation therapy is most commonly utilized to offer palliative care. In select cases, it can be used as the primary treatment for malignant peritoneal neoplasm and other diseases before they are treated with medication or surgery." - Anonymous Online Contributor

Unverified Answer

To what extent has Radiation therapy been investigated in prior research?

"Currently, there are 1432 active Radiation therapy trials in progress with 365 of those studies at the Phase 3 level. Additionally, 74621 locations worldwide provide services for these experiments. Shanghai is a notable city as it has several clinical trial sites devoted to researching this particular treatment type." - Anonymous Online Contributor

Unverified Answer

What adverse effects may arise from radiation-based treatments?

"Radiation therapy was rated a 2 on our internal scale, as there is currently no evidence of efficacy but some data indicating safety." - Anonymous Online Contributor

Unverified Answer

How extensive is the current enrollment for this trial?

"Affirmative. According to clinicaltrials.gov, the trial is presently recruiting participants; it was first shared on 20th June 2019 and most recently updated on 27th June 2022. The study requires 27 patients from a single site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top