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Radiation Therapy

Adaptive Radiation Therapy for Non-Small Cell Lung Cancer

N/A

Recruiting

Led By Salma K Jabbour

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytological evidence of locally advanced, biopsy-proven, stage II (inoperable), III-or oligometastatic stage IV NSCLC planned to be treated with chemoradiation with concurrent or adjuvant immunotherapy

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 months post chemoradiation

Awards & highlights

Study Summary

This trial is studying whether re-designing a patient's radiation treatment plan at set intervals will reduce side effects from the treatment.

Who is the study for?

This trial is for adults with stage II-IV non-small cell lung cancer who are in good physical condition (ECOG 0 or 1) and have not had prior treatments other than specific chemoradiation. They must be able to use effective contraception, provide consent, and have no other health issues that could affect the study.Check my eligibility

What is being tested?

The trial tests whether adaptive radiation planning can reduce side effects from radiation treatment and immunotherapy. It involves adjusting the radiation plan at set intervals based on tumor size changes during treatment to minimize exposure to healthy tissue.See study design

What are the potential side effects?

Potential side effects may include typical reactions associated with radiation such as skin irritation, fatigue, nausea, and inflammation of tissues exposed to radiation. Immunotherapy-related side effects might also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer is at an advanced stage but planned to be treated with specific therapies.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am willing to use birth control or abstain from sex during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 months post chemoradiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 months post chemoradiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months post chemoradiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determine if adaptive radiation therapy reduces radiation induced pneumonitis rates

Secondary outcome measures

Change in toxicities, including cardiac and esophageal toxicities

Determine if adaptive radiation therapy reduces radiation doses to heart and lung

Dosimetric changes in lung, heart, and esophageal dosimetry parameters in patients treated with adaptive radiation planning

+2 more

Side effects data

From 2023 Phase 2 trial • 257 Patients • NCT01333033

79%

Nausea

64%

Platelet count decreased

46%

Vomiting

46%

Neutrophil count decreased

41%

Paresthesia

41%

Diarrhea

38%

Lymphocyte count decreased

28%

Dysphagia

26%

Dyspnea

23%

Fatigue

21%

White blood cell decreased

18%

Anemia

15%

Anorexia

15%

Headache

13%

Peripheral motor neuropathy

13%

Dehydration

10%

Laryngopharyngeal dysesthesia

10%

Flu like symptoms

10%

Fever

10%

Hyponatremia

10%

Myalgia

Insomnia

Esophageal pain

Esophagitis

Chills

Weight loss

Hyperglycemia

Hypocalcemia

Arthralgia

Hypotension

Hypoalbuminemia

Sinus tachycardia

Pain

Bloating

Constipation

Hypokalemia

Peripheral sensory neuropathy

Aspiration

Alopecia

Skin and subcut tissue disord - Oth spec

Febrile neutropenia

Hypoxia

Soft tissue infection

Hypophosphatemia

Depression

Pharyngolaryngeal pain

Dysgeusia

Gastroparesis

Pain in extremity

Edema limbs

Stomach pain

Cardiac arrest

Thrombotic thrombocytopenic purpura

Esophageal hemorrhage

Esophageal obstruction

Lung infection

Sepsis

Tooth infection

Alkaline phosphatase increased

Back pain

Atelectasis

Cough

Epistaxis

Hiccups

Hoarseness

Pleural effusion

Pleuritic pain

Rash maculo-papular

Hypertension

Phlebitis

Superficial thrombophlebitis

Vascular disorders - Other, specify

Thromboembolic event

Blood and lymph sys disorders - Oth Spec

Palpitations

Sinus bradycardia

100%

80%

60%

40%

20%

Study treatment Arm

FOLFOX Non-Responder

CP Responder

FOLFOX Responder

CP Non-Responder

CP No Cross-over

FOLFOX No Cross-over

Trial Design

1Treatment groups

Experimental Treatment

Group I: Supportive care (CT simulation, contrast agent)Experimental Treatment2 Interventions

Patients undergo CT stimulation with or without IV contrast over 1.5 hours on days -15 to -1, then undergo SOC chemoradiation on days 1-40. Patients also undergo additional CT scan simulations without IV contrast over 20 minutes each on days 15 and 29.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2720

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,667 Previous Clinical Trials

40,926,098 Total Patients Enrolled

Rutgers, The State University of New JerseyLead Sponsor

429 Previous Clinical Trials

64,198 Total Patients Enrolled

Salma K JabbourPrincipal InvestigatorRutgers Cancer Institute of New Jersey

Media Library

Radiation Treatment (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04751747 — N/A

Non-Small Cell Lung Cancer Research Study Groups: Supportive care (CT simulation, contrast agent)

Non-Small Cell Lung Cancer Clinical Trial 2023: Radiation Treatment Highlights & Side Effects. Trial Name: NCT04751747 — N/A

Radiation Treatment (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04751747 — N/A

Frequently Asked Questions

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

Are there vacancies for participants still available in this trial?

"Affirmative. The details posted on clinicaltrials.gov demonstrate that this trial, launched on February 11th 2021, is actively recruiting participants. Currently it seeks 34 volunteers to be sourced from 2 sites of recruitment."

Answered by AI

What is the total participant count for this trial?

"Affirmative. The data listed on clinicaltrials.gov indicates that this research project is actively recruiting subjects, having been posted originally on February 11th 2021 and last updated November 2nd 2022; it requires 34 participants to be recruited from two separate locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Adaptive Radiation Planning for the Reduction of Radiation-Induced Toxicity in Patients With Stage II-IV Non-small Cell Lung Cancer

Salma Jabbour, MD 2021. "Adaptive Radiation Planning for the Reduction of Radiation-Induced Toxicity in Patients With Stage II-IV Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04751747.

All > Toxicity