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Lung CancerPhase 2NCT00096226

Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage III Non-Small Cell Lung Cancer

A Phase 2 study testing Induction Carboplatin, Induction Paclitaxel and Resection in people with Lung Cancer, run by Radiation Therapy Oncology Group at 22 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
Induction Carboplatin, Induction Paclitaxel and Resection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
22 sitesUnited States
Study dates
Sep 2004to 16 May 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with Stage IIIA (T1-3 N2) or Stage IIIB (N3, excluding supraclavicular involvement) non-small cell lung cancer documented by biopsy or cytology (Pancoast tumors are eligible if pathologic evidence of mediastinal nodal disease is present);
  • Disease must be measurable;
  • Mediastinal lymph nodes must be proven positive by pathologic review. All patients must undergo mediastinoscopy, thoracoscopy, Chamberlain procedure, or transbronchial needle aspirate to evaluate extent of nodal involvement. Any lymph node assessed by mediastinoscopy and found to be positive will be defined as N2 disease;
  • Patients ≥ 18 years of age;
  • Life expectancy ≥ 6 months;
  • Zubrod performance status 0- 1 (See Appendix II);
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  • Pretreatment laboratory values must be as follows: White blood cell count (WBC) count: ≥ 3,000/mm^3; Absolute granulocyte count: ≥ 1,500/mm^3; Platelets: ≥ 100,000/mm3; Total bilirubin: ≤ 1.5 x institutional upper limit of normal (ULN); Serum creatinine: ≤ 1.5 x institutional ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x institutional ULN; serum albumin: ≥ 3.0 g/dL
  • Baseline forced expiratory volume (FEV1) must be at least 2.0 liters; if less than 2.0 then V/Q scan is required and projected post-operative FEV1 must be > 800 cc based on the following formula using the quantitative Ventilation/perfusion (V/Q) scan: FEV1 = FEV1 x % perfusion to uninvolved lung from quantitative lung V/Q scan report.
  • Patient evaluation and acceptance by thoracic surgery, medical oncology, and radiation oncology; patient must be a potential surgical candidate prior to the initiation of therapy;
  • Women of childbearing potential and male participants must practice an effective method of contraception during the study;
  • Pretreatment evaluations required for eligibility include:
  • A complete medical history \& physical examination to include Zubrod performance status, neurologic assessment, recent weight loss, usual weight, concurrent non-malignant disease and therapy;
  • Location, type, and size of measurable lesion must be recorded prior to treatment;
  • Complete blood count (CBC) with differential, platelet count, electrolytes, and Mg++ within 14 days prior to study entry;
  • Twelve-channel serum multiple analysis (SMA-12): Total protein, Albumin, Calcium, Glucose, Blood urea nitrogen (BUN), Creatinine, Alkaline Phosphatase, Lactate dehydrogenase (LDH), Total Bilirubin, serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) within 14 days prior to study entry;
  • Women of childbearing potential must have a negative pre-study serum or urine pregnancy test within 14 days prior to study entry.
  • Mediastinoscopy, thoracoscopy, Chamberlain procedure, or bronchoscopy with transbronchial needle aspirate to evaluate the extent of lymph node involvement;
  • Computed tomography (CT) scan of the chest to include liver, and adrenal glands within 6 weeks prior to study entry;
  • Positron emission tomography (PET) scan within 8 weeks prior to study entry. Any suspicious areas outside of the local regional disease requires documented evaluation of these findings to exclude metastatic disease;
  • CT scan or magnetic resonance imaging (MRI) of the brain within 6 weeks prior to study entry;
  • Electrocardiogram (EKG) and pulmonary function tests including forced vital capacity (FVC), FEV-1, and diffusing capacity of carbon monoxide (DLCO), within 8 weeks prior to study entry; V/Q scan, if applicable, within 8 weeks prior to study entry.
  • Patients must sign a study-specific informed consent prior to study entry.

Who cannot join

  • Small cell lung cancer; distant metastatic disease;
  • Evidence of clinical or radiographic supraclavicular lymph node involvement;
  • Bronchioalveolar carcinoma with lobar or multilobar involvement;
  • Unintentional weight loss > 5% within 6 months prior to study entry, or Zubrod performance status 2 or greater;
  • Primary tumor location prevents delivery of 60 Gy and simultaneously limiting spinal cord dose to 48 Gy;
  • Patients with malignant pleural effusion;
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  • Clinically evident superior vena cava syndrome;
  • Prior systemic chemotherapy or radiation therapy to the thorax;
  • Patients with known hypersensitivity to Cremophor EL;
  • Patients receiving other investigational therapy;
  • Pregnant or lactating women are ineligible, as treatment involves unforeseeable risks to the participant and to the embryo or fetus;
  • Patients with an active serious infection or other serious underlying medical condition that would impair their ability to complete protocol treatment;
  • Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent.

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

United States22 sites

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • St. Luke's Cancer Network at St. Luke's Hospital

    Bethlehem, Pennsylvania, 18015

  • Cancer Institute of New Jersey at Cooper University Hospital - Camden

    Camden, New Jersey, 08103

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • Leo W. Jenkins Cancer Center at ECU Medical School

    Greenville, North Carolina, 27835-6028

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center

    Kingsport, Tennessee, 37662

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089-9181

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Veterans Affairs Medical Center - Milwaukee

    Milwaukee, Wisconsin, 53295

  • Methodist Estabrook Cancer Center

    Omaha, Nebraska, 68114

  • Arizona Oncology Services Foundation

    Phoenix, Arizona, 85013

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea

    Scottsdale, Arizona, 85260

  • Cancer Institute at St. John's Hospital

    Springfield, Illinois, 62702

  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

    St Louis, Missouri, 63110

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308

  • Cancer Institute of New Jersey at Cooper - Voorhees

    Voorhees Township, New Jersey, 08043

  • Schiffler Cancer Center at Wheeling Hospital

    Wheeling, West Virginia, 26003

Other trials in United States

About this study

Official title: A Phase II Trial Of Neoadjuvant Therapy With Concurrent Chemotherapy And High Dose Radiotherapy Followed By Surgical Resection And Consolidative Therapy For Locally Advanced Non-Small Cell Lung Carcinoma

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving paclitaxel and carboplatin together with radiation therapy before surgery may shrink the tumor so that it can be removed. Giving chemotherapy after surgery may kill any tumor cells remaining after surgery.

PURPOSE: This phase II trial is studying how well giving paclitaxel and carboplatin together with radiation therapy works in treating patients who are undergoing surgery for stage III non-small cell lung cancer.

Read the detailed description

OBJECTIVES:

  • Determine the mediastinal node clearance rate in patients with stage IIIA or IIIB non-small cell lung cancer treated with neoadjuvant induction chemoradiotherapy comprising paclitaxel, carboplatin, and high-dose radiotherapy followed by surgical resection for patients found to be resectable and consolidative chemotherapy comprising paclitaxel and carboplatin.
  • Determine the rate of complete pathological response in patients treated with this regimen.
  • Determine the feasibility of surgical resection after neoadjuvant induction chemoradiotherapy in these patients.
  • Determine disease-free and overall survival of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.
Conditions
Lung Cancer
Being tested
Induction Carboplatin, Induction Paclitaxel, Resection, Consolidation Carboplatin, Radiation Therapy
Keywords
stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Induction CarboplatinDrug

  • Induction PaclitaxelDrug

  • ResectionProcedure or surgery

  • Consolidation CarboplatinDrug

  • Radiation TherapyRadiation

  • Consolidation PaclitaxelDrug

Study groups in NCT00096226
Study groupRoleWhat they receive
Chemoradiation, Surgery, ChemotherapyExperimentalInduction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
Receives: Drug: Induction Carboplatin; Drug: Induction Paclitaxel; Procedure: Resection; Drug: Consolidation Carboplatin; Radiation: Radiation Therapy; Drug: Consolidation Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mediastinal Nodal Clearance Rate

    If at least 12 of the first 21 evaluable patients and at least 27 of the the first 45 evaluable patients have mediastinal nodal clearance (MNC), then a conclusion of a 70% MNC rate (compared to 50%) is made using Simon's two-stage design with 90% power and 10% type I error.

    Measured: At completion of concurrent chemotherapy and radiation therapy, up to 14 weeks.

Secondary outcomes (7)

  1. Percentage of Patients With Complete Pathological Response After Concurrent Chemotherapy and Radiation Therapy

    Complete pathologic response is defined as complete resection achieved and no evidence of viable tumor in the entire resection specimen.

    Measured: At time of surgery (16-18 weeks)

  2. Percentage of Patients With Major Surgical Morbidities Within 30 Days of Surgery

    The surgical morbidities occurring within 30 days following resection were assessed and graded using the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0. A major morbidity is considered a grade 3 or higher of any of the following: pneumonitis, infection, atelectasis, chest tube drainage/bronchial stump leak, pneumothorax, chylothorax, cardiac ischemia/infarction, pulmonary thrombosis/embolism, supraventricular atrial arrhythmia, ventricular arrhythmia, post-operative hemorrhage, pulmonary/upper respiratory fistula, pleural effusion, or death.

    Measured: From 0 to 30 days following surgery (surgery occurs within 16-18 weeks after registration)

  3. Percentage of Patients Able to Undergo Surgical Resection

    Measured: At time of surgery (16-18 weeks)

  4. Distribution of R0, R1, and R2 Resections After Chemotherapy

    An R0 resection is defined as a complete resection of all disease with negative margins and the highest lymph node resected negative for residual tumor. An R1 resection is defined as a complete resection of all disease with pathology of positive margins, pathologic evidence of tumor cells in the highest lymph node resected in the mediastinum, or extracapsular nodal spread. An R2 resection is defined as gross residual disease left behind after surgical resection.

    Measured: At time of surgery (16-18 weeks)

  5. Overall Survival at Two Years

    Overall survival time is defined as time from registration to the date of death from any cause. Overall survival rate is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.

    Measured: From registration to two years

  6. Progression-free Survival at Two Years

    Progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions. An event for progression-free survival is the first occurrence of progression or death due to any cause. Progression-free survival time is defined as the time from study entry to the the date progression or death, or last known follow-up (censored) if neither progression nor death occurred. Progression-free survival rate is estimated using the Kaplan-Meier method.

    Measured: From registration to two years

  7. Distribution of Highest Grade Adverse Event

    The number of patients whose highest grade adverse event (AE) reported was 3, 4, or 5 was calculated. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Number of patients with highest grade of 3, 4, and 5 are presented.

    Measured: From start of treatment to end of follow-up, a maximum of 64.3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2004 (estimated)
  2. Study startSep 2004
  3. Primary completionApr 2012
  4. Study completion16 May 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00096226
Sponsor's protocol ID
RTOG-0229
Other IDs
CDR0000389508
Status last verified
Sep 2019
First submitted
9 Nov 2004
Last updated
18 Sep 2019
Data monitoring committee
Yes

Publications

  • Suntharalingam M, Paulus R, Edelman MJ, Krasna M, Burrows W, Gore E, Wilson LD, Choy H. Radiation therapy oncology group protocol 02-29: a phase II trial of neoadjuvant therapy with concurrent chemotherapy and full-dose radiation therapy followed by surgical resection and consolidative therapy for locally advanced non-small cell carcinoma of the lung. Int J Radiat Oncol Biol Phys. 2012 Oct 1;84(2):456-63. doi: 10.1016/j.ijrobp.2011.11.069. Epub 2012 Apr 28.

    PubMed 22543206

  • Suntharalingam M, Paulus R, Edelman MJ, et al.: RTOG 0229: A phase II trial of neoadjuvant therapy with concurrent chemotherapy and high-dose radiotherapy (XRT) followed by resection and consolidative therapy for LA-NSCLC. [Abstract] J Clin Oncol 28 (Suppl 15): A-7024, 2010.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Induction Carboplatin, Induction Paclitaxel and Resection in people with Lung Cancer, run by Radiation Therapy Oncology Group at 22 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mediastinal Nodal Clearance Rate (time frame: At completion of concurrent chemotherapy and radiation therapy, up to 14 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00096226, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019.

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