NCT00096226

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 lung-cancer

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_2 lung-cancer

Geographic Reach
1 country

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2004

Completed
Same day until next milestone

First Posted

Study publicly available on registry

November 9, 2004

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

February 27, 2014

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2016

Completed
Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

7.6 years

First QC Date

November 9, 2004

Results QC Date

January 16, 2014

Last Update Submit

September 4, 2019

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancer

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (7)

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

    At time of surgery (16-18 weeks)

  • Percentage of Patients With Major Surgical Morbidities Within 30 Days of Surgery

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

  • Percentage of Patients Able to Undergo Surgical Resection

    At time of surgery (16-18 weeks)

  • Distribution of R0, R1, and R2 Resections After Chemotherapy

    At time of surgery (16-18 weeks)

  • Overall Survival at Two Years

    From registration to two years

  • +2 more secondary outcomes

Study Arms (1)

Chemoradiation, Surgery, Chemotherapy

EXPERIMENTAL

Induction 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.

Drug: Induction CarboplatinDrug: Induction PaclitaxelProcedure: ResectionDrug: Consolidation CarboplatinRadiation: Radiation TherapyDrug: Consolidation Paclitaxel

Interventions

Induction CarboplatinDRUG
Chemoradiation, Surgery, Chemotherapy
Induction PaclitaxelDRUG
Chemoradiation, Surgery, Chemotherapy
ResectionPROCEDURE
Chemoradiation, Surgery, Chemotherapy
Consolidation CarboplatinDRUG
Chemoradiation, Surgery, Chemotherapy
Radiation TherapyRADIATION
Chemoradiation, Surgery, Chemotherapy
Consolidation PaclitaxelDRUG
Chemoradiation, Surgery, Chemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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);
  • 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;
  • +7 more criteria

You may not qualify if:

  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Arizona Oncology Services Foundation

Phoenix, Arizona, 85013, United States

Location

Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea

Scottsdale, Arizona, 85260, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

Tallahassee Memorial Hospital

Tallahassee, Florida, 32308, United States

Location

Cancer Institute at St. John's Hospital

Springfield, Illinois, 62702, United States

Location

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Saint Joseph Mercy Cancer Center

Ann Arbor, Michigan, 48106-0995, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

Methodist Estabrook Cancer Center

Omaha, Nebraska, 68114, United States

Location

Cancer Institute of New Jersey at Cooper University Hospital - Camden

Camden, New Jersey, 08103, United States

Location

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

Leo W. Jenkins Cancer Center at ECU Medical School

Greenville, North Carolina, 27835-6028, United States

Location

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

Bethlehem, Pennsylvania, 18015, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center

Kingsport, Tennessee, 37662, United States

Location

Schiffler Cancer Center at Wheeling Hospital

Wheeling, West Virginia, 26003, United States

Location

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, 54307-3508, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Veterans Affairs Medical Center - Milwaukee

Milwaukee, Wisconsin, 53295, United States

Location

Related Publications (2)

  • 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.

    PMID: 22543206RESULT

  • 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.

    RESULT

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

Title
Wendy Seiferheld
Organization
Radiation Therapy Oncology Group (RTOG)
wseiferheld@acr.org

Study Officials

  • Mohan Suntharalingam, MD

    University of Maryland Greenebaum Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2004

First Posted

November 9, 2004

Study Start

September 1, 2004

Primary Completion

April 1, 2012

Study Completion

May 16, 2016

Last Updated

September 18, 2019

Results First Posted

February 27, 2014

Record last verified: 2019-09

Locations

US(22)