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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up participants will be followed for 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

Non-Small Cell Lung Carcinoma

Secondary outcome measures

Overall survival

To determine Lung cancer Disease specific survival

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%

Decreased appetite

25%

Anaemia

24%

Abdominal pain

23%

Rash

21%

Headache

19%

Epistaxis

15%

Drug hypersensitivity

15%

Arthralgia

15%

Thrombocytopenia

15%

Neuropathy peripheral

13%

Dysgeusia

13%

Stomatitis

12%

Asthenia

12%

Dizziness

12%

Dyspepsia

12%

Leukopenia

11%

Dyspnoea

11%

Nail disorder

11%

Peripheral sensory neuropathy

Mucosal inflammation

Pruritus

Muscle spasms

Cystitis

Insomnia

Hemorrhoids

Back pain

Hypertension

Pain in extremity

Urinary tract infection

Flushing

Cough

Myalgia

Musculoskeletal pain

Erythema

Bone pain

Nasopharyngitis

Abdominal pain upper

Chest pain

Pyrexia

Dry skin

Lethargy

Paraesthesia

Abdominal pain lower

Vaginal discharge

Oedema peripheral

Phlebitis

Intestinal obstruction

Ascites

Gastrointestinal haemorrhage

Abdominal distension

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

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

~480

carboplatin

2010

Completed Phase 3

~4790

paclitaxel

1996

Completed Phase 3

~4310

hypofractionated radiation therapy

2008

Completed Phase 3

~290

image-guided radiation therapy

2008

Completed Phase 2

~180

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor

359 Previous Clinical Trials

26,046 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,124 Total Patients Enrolled

Percy LeePrincipal InvestigatorJonsson Comprehensive Cancer Center

1 Previous Clinical Trials

2 Total Patients Enrolled

Media Library

Carboplatin, Paclitaxel (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT01345851 — N/A

Lung Adenocarcinoma Research Study Groups: Treatment (dose-escalation of RT)

Lung Adenocarcinoma Clinical Trial 2023: Carboplatin, Paclitaxel Highlights & Side Effects. Trial Name: NCT01345851 — N/A

Carboplatin, Paclitaxel (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01345851 — N/A

Frequently Asked Questions

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

To what extent is the study participant pool expanding?

"This clinical trial has ceased recruitment, with the posting dated March 23rd 2011 and its last update on December 2nd 2021. For those still looking for medical studies, 1949 trials involving lung cancer are currently open to applicants as well as 1177 trails offering carboplatin treatment."

Answered by AI

What conditions does carboplatin typically address?

"Physcians can utilise carboplatin to aid in the management of melanoma, neoplasm metastasis, and non-hodgkin lymphoma."

Answered by AI

Is enrollment for this trial still open to the public?

"This clinical trial is not actively recruiting participants. The initial post date was March 23, 2011 and the last update occurred on December 2nd of 2021. However there are 1949 studies related to lung cancer and 1177 trials involving carboplatin that are currently searching for eligible candidates."

Answered by AI

What additional experiments have occurred involving carboplatin?

"Presently, 1177 clinical trials are in progress studying the effects of carboplatin with 333 of them being Phase 3. Concentrated mainly around Shanghai, there are 66707 medical centres examining this medication."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Image-Guided Hypofractionated Radiation Therapy With Stereotactic Body Radiation Therapy Boost and Combination Chemotherapy in Treating Patients With Stage II-III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery

2011. "Image-Guided Hypofractionated Radiation Therapy With Stereotactic Body Radiation Therapy Boost and Combination Chemotherapy in Treating Patients With Stage II-III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01345851.

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