What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include radiation therapy and chemoradiotherapy. Radiation therapy can cause side effects such as fatigue, skin irritation, and inflammation of the esophagus (esophagitis), which can lead to difficulty swallowing. Chemoradiotherapy, which combines chemotherapy with radiation, can exacerbate these side effects and add others, such as nausea, vomiting, and increased risk of infections due to lowered blood cell counts. Adaptive radiation planning aims to reduce these side effects by periodically adjusting the radiation plan to minimize exposure to healthy tissue, potentially decreasing the incidence and severity of these adverse effects.

What prior FDA approvals exist?

FDA approvals for the treatment of Non-Small Cell Lung Cancer (NSCLC) have included various approaches such as targeted therapies, immunotherapies, and chemotherapies. Treatments like pembrolizumab (Keytruda) and nivolumab (Opdivo) are immunotherapies that have been approved for NSCLC, often used in combination with radiation therapy. These treatments aim to enhance the body's immune response against cancer cells. While adaptive radiation planning itself is a newer approach being studied to minimize radiation exposure to healthy tissue, the concept aligns with the broader goal of precision medicine in NSCLC treatment, which includes the use of advanced radiation techniques and immunotherapies to improve outcomes and reduce side effects.

What other types of research exist?

Promising, novel alternatives to Adaptive Radiation Planning for NSCLC patients include: 1) MR-Guided Midtreatment Adaptive Planning, which uses MRI to adapt the treatment plan based on tumor response during therapy, potentially sparing surrounding critical structures. 2) Hypofractionated Stereotactic Radiation Therapy (HSRT), which delivers higher doses of radiation in fewer sessions, targeting the tumor more precisely and reducing exposure to healthy tissue. 3) Real-Time In Vivo Portal Dosimetry Systems, which monitor anatomical changes in real-time to adapt the radiation plan dynamically, ensuring accurate targeting and minimizing side effects.

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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

Must not have

Active second cancers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 months post chemoradiation

Awards & highlights

No Placebo-Only Group

Summary

This trial studies whether updating the radiation treatment plan can reduce side effects in patients with advanced lung cancer. The goal is to better target the tumor while protecting healthy tissue.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have another type of cancer that is currently active.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine if adaptive radiation therapy reduces radiation induced pneumonitis rates

Secondary study objectives

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

Hypotension

Insomnia

Esophageal pain

Esophagitis

Chills

Weight loss

Hyperglycemia

Hypocalcemia

Arthralgia

Hypoalbuminemia

Sinus tachycardia

Pain

Bloating

Constipation

Hypokalemia

Peripheral sensory neuropathy

Aspiration

Alopecia

Skin and subcut tissue disord - Oth spec

Febrile neutropenia

Soft tissue infection

Hypoxia

Pharyngolaryngeal pain

Hypophosphatemia

Depression

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2740

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include radiation therapy, chemotherapy, and immunotherapy. Radiation therapy damages the DNA of cancer cells, leading to their death. Chemotherapy uses drugs to target and inhibit the growth of rapidly dividing cancer cells. Immunotherapy enhances the immune system's ability to recognize and destroy cancer cells. Adaptive radiation planning, which periodically adjusts the radiation treatment plan to account for changes in tumor size and position, is crucial for NSCLC patients as it aims to improve treatment precision and effectiveness while minimizing damage to healthy tissues and reducing side effects.