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Chemotherapy

Combined Chemoradiotherapy for Non-Small Cell Lung Cancer

N/A

Waitlist Available

Led By Percy Lee

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Karnofsky performance status >= 70

Histologically confirmed primary non-metastatic NSCLC of eligible histological subtypes

Must not have

Use of concurrent gemcitabine-based chemotherapy during radiotherapy

Patients who have previously received therapeutic radiation therapy to the chest

Timeline

Screening 3 weeks

Treatment Varies

Follow Up participants will be followed for 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to give radiation and chemotherapy to patients with stage II-III NSCLC that can't be removed by surgery. The new way may kill more tumor cells and spare more healthy tissue.

Who is the study for?

This trial is for adults with stage II-III non-small cell lung cancer that can't be surgically removed. They must have a Karnofsky performance status of at least 70, meaning they are able to care for themselves. Pregnant women or those not using contraception are excluded, as well as patients who've had chest radiation before or refuse consent.

What is being tested?

The study tests if combining image-guided hypofractionated RT (a type of targeted radiation therapy) with a boost and chemotherapy drugs carboplatin and paclitaxel is more effective in killing tumor cells while sparing normal tissue compared to standard treatments.

What are the potential side effects?

Possible side effects include skin reactions from radiation, fatigue, nausea from chemotherapy, potential damage to surrounding organs like the lungs or heart, and an increased risk of infection due to lowered white blood cell counts.

Eligibility Criteria

Inclusion Criteria

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

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I am able to care for myself but may not be able to do active work.

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My lung cancer is confirmed and has not spread beyond my lungs.

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My lung cancer is at stage II or III according to the AJCC 7th edition.

Exclusion Criteria

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

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I am currently receiving gemcitabine-based chemotherapy along with radiotherapy.

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I have had radiation therapy to my chest before.

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I currently have an infection in my body, lungs, or heart lining.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ participants will be followed for 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~participants will be followed for 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and participants will be followed for 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Non-Small Cell Lung Carcinoma

Secondary study objectives

To determine tumor Local control

Side effects data

From 2008 Phase 2 trial • 149 Patients • NCT02004093

59%

Nausea

59%

Diarrhoea

48%

Neutropenia

40%

Fatigue

32%

Vomiting

29%

Alopecia

27%

Constipation

25%

Anaemia

25%

Decreased appetite

24%

Abdominal pain

23%

Rash

21%

Headache

19%

Epistaxis

15%

Arthralgia

15%

Drug hypersensitivity

15%

Thrombocytopenia

15%

Neuropathy peripheral

13%

Stomatitis

13%

Dysgeusia

12%

Asthenia

12%

Dizziness

12%

Dyspepsia

12%

Leukopenia

11%

Nail disorder

11%

Dyspnoea

11%

Peripheral sensory neuropathy

Mucosal inflammation

Pruritus

Muscle spasms

Cystitis

Hemorrhoids

Back pain

Hypertension

Insomnia

Pain in extremity

Urinary tract infection

Chest pain

Erythema

Abdominal pain upper

Bone pain

Myalgia

Musculoskeletal pain

Cough

Nasopharyngitis

Flushing

Pyrexia

Dry skin

Paraesthesia

Lethargy

Abdominal pain lower

Vaginal discharge

Oedema peripheral

Phlebitis

Intestinal obstruction

Ascites

Abdominal distension

Gastrointestinal haemorrhage

Local swelling

Pulmonary embolism

Diaphragmatic hernia

Cardiac failure congestive

Hepatic lesion

Blood glucose increased

Lower respiratory tract infection

Pneumonia

Syncope

Ileus paralytic

Left ventricular dysfunction

100%

80%

60%

40%

20%

Study treatment Arm

Chemotherapy + Pertuzumab

Chemotherapy

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: Treatment (dose-escalation of RT)Experimental Treatment6 Interventions

Patients undergo image-guided hypofractionated RT over 35 minutes 5 days a week for 2 weeks followed by 5 fractions of hypofractionated RT boost. Patients also receive standard carboplatin and paclitaxel for 3 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

stereotactic body radiation therapy

2019

Completed Phase 2

~470

carboplatin

2010

Completed Phase 3

~4790