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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 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%
Anaemia
25%
Decreased appetite
24%
Abdominal pain
23%
Rash
21%
Headache
19%
Epistaxis
15%
Arthralgia
15%
Drug hypersensitivity
15%
Thrombocytopenia
15%
Neuropathy peripheral
13%
Dysgeusia
13%
Stomatitis
12%
Dizziness
12%
Asthenia
12%
Dyspepsia
12%
Leukopenia
11%
Dyspnoea
11%
Nail disorder
11%
Peripheral sensory neuropathy
9%
Mucosal inflammation
9%
Pruritus
9%
Muscle spasms
9%
Cystitis
8%
Insomnia
8%
Back pain
8%
Hemorrhoids
8%
Hypertension
8%
Pain in extremity
8%
Urinary tract infection
7%
Musculoskeletal pain
7%
Chest pain
7%
Cough
7%
Abdominal pain upper
7%
Flushing
7%
Nasopharyngitis
7%
Myalgia
7%
Erythema
7%
Bone pain
7%
Pyrexia
5%
Dry skin
5%
Paraesthesia
5%
Lethargy
5%
Abdominal pain lower
5%
Vaginal discharge
5%
Oedema peripheral
4%
Phlebitis
3%
Intestinal obstruction
1%
Ascites
1%
Gastrointestinal haemorrhage
1%
Abdominal distension
1%
Local swelling
1%
Pulmonary embolism
1%
Diaphragmatic hernia
1%
Cardiac failure congestive
1%
Hepatic lesion
1%
Blood glucose increased
1%
Lower respiratory tract infection
1%
Pneumonia
1%
Syncope
1%
Ileus paralytic
1%
Left ventricular dysfunction
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
361 Previous Clinical Trials
27,719 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,708 Previous Clinical Trials
40,932,700 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
~1 spots leftby Jan 2025