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Radiation Therapy

Surgery and Radiation Therapy vs Standard Care for Non-Small Cell Lung Cancer

Q: Has the FDA approved Therapeutic Conventional Surgery as a viable treatment?

<p>There is some clinical evidence indicating that Therapeutic Conventional Surgery is safe, thus our team has rated it a 2. No data exists yet to support its efficacy in this Phase 2 trial.</p>

Q: Are there any slots still open for this clinical experiment?

<p>Data hosted on clinicaltrials.gov reveals that this medical experiment, which was initially advertised on November 28th 2012 and last updated September 13th 2022, is not currently open to new participants. Though the trial has ended recruitment, there are still 1910 other studies looking for volunteers at present.</p>

Phase 2

Waitlist Available

Led By Daniel Gomez

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients with a diagnosis of American Joint Committee on Cancer (AJCC) 7th Edition stage IV NSCLC

Patients with standard induction chemotherapy planned as at least 4 cycles of platinum doublet chemotherapy for metastatic disease (with or without bevacizumab); or specific targeted therapy for EGFR mutation positive or EML4-ALK fusions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study Summary

This trial studies surgery, radiation therapy, and/or standard therapy as possible treatments for stage IV non-small cell lung cancer.

Who is the study for?

This trial is for patients with stage IV non-small cell lung cancer who've had prior treatment. They must be suitable for local therapy to all disease sites, have three or fewer metastatic lesions, and completed standard chemotherapy. Participants need proper organ function, an ECOG status of <=2, and agree to contraception.Check my eligibility

What is being tested?

The study compares the effectiveness of surgery and/or radiation therapy against standard care or observation in treating previously treated stage IV non-small cell lung cancer. It aims to determine if these interventions can better eliminate tumor cells than current practices.See study design

What are the potential side effects?

Potential side effects may include typical risks associated with surgery (like infection or bleeding) and radiation therapy (such as skin irritation, fatigue, nausea). The exact side effects will depend on individual patient factors and the specific treatments received.

Eligibility Criteria

Inclusion Criteria

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

Select...

My lung cancer is at stage IV according to the AJCC 7th Edition.

Select...

I am set to receive specific chemotherapy or targeted therapy for my metastatic cancer.

Select...

My cancer has spread to 3 or fewer places and hasn't gotten worse.

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

I completed at least 4 cycles of specific chemotherapy for my metastatic cancer.

Select...

My lung cancer was confirmed by a biopsy.

Select...

I have 3 or fewer cancer spread sites; lung nodes count as one.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Progression-free survival (PFS)

Secondary outcome measures

Impact of crossover without RECIST progression

Incidence of toxicities

Overall survival

+3 more

Side effects data

From 2013 Phase 3 trial • 4312 Patients • NCT00011986

97%

Neutropenia

94%

Leukopenia

80%

Anemia

76%

Thrombocytopenia

47%

Gastrointestinal

43%

Constitutional

38%

Other Hemotologic

34%

Pain

17%

Infection/Fever

17%

Peripheral neurologic

17%

Pulmonary

14%

Neurologic

11%

Metabolic

10%

2nd Primary

Hepatic

Dermatologic

Cardiovascular

Allergy

Hemorrhage

Genitourinary/Renal

Musculoskeletal

Ocular/Visual

Endocrine

Auditory

Thrombosis/Embolism

Ileus

Infection Documented W Grd 3/4 Neutropn.

Infection Without Neutropenia

Coagulation

Sexual

Platelets

Allergic Reaction/Hypersensitivity

Febrile Neutropenia-Fuo Infect Not Docum

100%

80%

60%

40%

20%

Study treatment Arm

Carbo/Gemcitabine - Carbo/Taxol

Carbo/Taxol/Gemcitabine

Carbo/Taxol/Doxil

Carbo/Topotecan - Carbo/Taxol

Carbo/Taxol

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (immediate LCT)Experimental Treatment4 Interventions

Patients undergo ablation of all residual local and metastatic sites of disease by surgery and/or EBRT. After completion of LCT, patients undergo either surveillance or maintenance treatment at the discretion of the treating physician.

Group II: Arm II (delayed/no LCT)Active Control4 Interventions

Patients undergo standard maintenance therapy or clinical observation, based on physician choice. Patients may cross-over to Arm I due to RECIST progression or toxicity at the treating physician's discretion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9850

External Beam Radiation Therapy

2006

Completed Phase 3

~3070

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,696 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,068 Total Patients Enrolled

Daniel GomezPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

24 Total Patients Enrolled

Media Library

External Beam Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01725165 — Phase 2

Non-Small Cell Lung Cancer Research Study Groups: Arm I (immediate LCT), Arm II (delayed/no LCT)

Non-Small Cell Lung Cancer Clinical Trial 2023: External Beam Radiation Therapy Highlights & Side Effects. Trial Name: NCT01725165 — Phase 2

External Beam Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01725165 — Phase 2

Frequently Asked Questions

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

Has the FDA approved Therapeutic Conventional Surgery as a viable treatment?

"There is some clinical evidence indicating that Therapeutic Conventional Surgery is safe, thus our team has rated it a 2. No data exists yet to support its efficacy in this Phase 2 trial."

Answered by AI

Are there any slots still open for this clinical experiment?

"Data hosted on clinicaltrials.gov reveals that this medical experiment, which was initially advertised on November 28th 2012 and last updated September 13th 2022, is not currently open to new participants. Though the trial has ended recruitment, there are still 1910 other studies looking for volunteers at present."

Answered by AI

Recent research and studies

International Journal of Radiation Oncology*Biology*PhysicsJournal

Immune and Circulating Tumor DNA Profiling After Radiation Treatment for Oligometastatic Non-small Cell Lung Cancer: Translational Correlatives from a Mature Randomized Phase II Trial

Tang, Chad, Won-Chul Lee, Alexandre Reuben, Lianpeng Chang, Hai Tran, Latasha Little, Curtis Gumbs, et al.. 2020. “Immune and Circulating Tumor DNA Profiling After Radiation Treatment for Oligometastatic Non-small Cell Lung Cancer: Translational Correlatives from a Mature Randomized Phase II Trial”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/j.ijrobp.2019.10.038.

The Lancet OncologyJournal

Local Consolidative Therapy Versus Maintenance Therapy or Observation for Patients with Oligometastatic Non-small-cell Lung Cancer Without Progression After First-line Systemic Therapy: A Multicentre, Randomised, Controlled, Phase 2 Study

Gomez, Daniel R, George R Blumenschein Jr, J Jack Lee, Mike Hernandez, Rong Ye, D Ross Camidge, Robert C Doebele, et al.. 2016. “Local Consolidative Therapy Versus Maintenance Therapy or Observation for Patients with Oligometastatic Non-small-cell Lung Cancer Without Progression After First-line Systemic Therapy: A Multicentre, Randomised, Controlled, Phase 2 Study”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(16)30532-0.

The Lancet OncologyJournal

clinicaltrials.govStudy

Surgery and/or Radiation Therapy or Standard Therapy and/or Clinical Observation in Treating Patients With Previously Treated Stage IV Non-small Cell Lung Cancer

2012. "Surgery and/or Radiation Therapy or Standard Therapy and/or Clinical Observation in Treating Patients With Previously Treated Stage IV Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01725165.