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

NCT ID: NCT00096226

Last Updated: 2019-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2016-05-16

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chemoradiation, Surgery, Chemotherapy

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.

Group Type: EXPERIMENTAL

Induction Carboplatin

Intervention Type: DRUG

Induction Paclitaxel

Intervention Type: DRUG

Resection

Intervention Type: PROCEDURE

Consolidation Carboplatin

Intervention Type: DRUG

Radiation Therapy

Intervention Type: RADIATION

Consolidation Paclitaxel

Intervention Type: DRUG

Interventions

Induction Carboplatin

Intervention Type: DRUG

Induction Paclitaxel

Intervention Type: DRUG

Resection

Intervention Type: PROCEDURE

Consolidation Carboplatin

Intervention Type: DRUG

Radiation Therapy

Intervention Type: RADIATION

Consolidation Paclitaxel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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);

2. Disease must be measurable;

3. 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;

4. Patients ≥ 18 years of age;

5. Life expectancy ≥ 6 months;

6. Zubrod performance status 0- 1 (See Appendix II);

7. 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

8. 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.

9. 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;

10. Women of childbearing potential and male participants must practice an effective method of contraception during the study;

11. 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.

12. Patients must sign a study-specific informed consent prior to study entry.

Exclusion Criteria

1. Small cell lung cancer; distant metastatic disease;

2. Evidence of clinical or radiographic supraclavicular lymph node involvement;

3. Bronchioalveolar carcinoma with lobar or multilobar involvement;

4. Unintentional weight loss > 5% within 6 months prior to study entry, or Zubrod performance status 2 or greater;

5. Primary tumor location prevents delivery of 60 Gy and simultaneously limiting spinal cord dose to 48 Gy;

6. Patients with malignant pleural effusion;

7. Clinically evident superior vena cava syndrome;

8. Prior systemic chemotherapy or radiation therapy to the thorax;

9. Patients with known hypersensitivity to Cremophor EL;

10. Patients receiving other investigational therapy;

11. Pregnant or lactating women are ineligible, as treatment involves unforeseeable risks to the participant and to the embryo or fetus;

12. Patients with an active serious infection or other serious underlying medical condition that would impair their ability to complete protocol treatment;

13. Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Radiation Therapy Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohan Suntharalingam, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland Greenebaum Cancer Center

Locations

Arizona Oncology Services Foundation

Phoenix, Arizona, United States

Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea

Scottsdale, Arizona, United States

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Tallahassee Memorial Hospital

Tallahassee, Florida, United States

Cancer Institute at St. John's Hospital

Springfield, Illinois, United States

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, United States

Saint Joseph Mercy Cancer Center

Ann Arbor, Michigan, United States

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, United States

Methodist Estabrook Cancer Center

Omaha, Nebraska, United States

Cancer Institute of New Jersey at Cooper University Hospital - Camden

Camden, New Jersey, United States

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, United States

Leo W. Jenkins Cancer Center at ECU Medical School

Greenville, North Carolina, United States

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

Bethlehem, Pennsylvania, United States

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, United States

Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center

Kingsport, Tennessee, United States

Schiffler Cancer Center at Wheeling Hospital

Wheeling, West Virginia, United States

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, United States

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, United States

Veterans Affairs Medical Center - Milwaukee

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 22543206 (View on PubMed)

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.

Reference Type: RESULT

Other Identifiers

CDR0000389508

Identifier Type: -

Identifier Source: secondary_id

RTOG-0229

Identifier Type: -

Identifier Source: org_study_id