Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer

NCT00043108 | Completed Phase 2 Results DMC

• 4 other identifiers: CDR0000256334P30CA006927NCI-G02-209702-014
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use 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 combination chemotherapy with radiation therapy before and after surgery may shrink the tumor so it can be removed during surgery and may kill any remaining tumor cells following surgery. PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel and carboplatin with radiation therapy and surgery in treating patients who have newly diagnosed locally advanced non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

• Toxic Death Rate

  5 years

• Complete Resection Rates

  5 years

Secondary Outcomes (3)

• Survival

  5 years

• Event-free Survival

  5 years

• Pathologic Complete Remission (pCR)

  5 years

Study Arms (1)

Treatment

EXPERIMENTAL

Thoracic RT (50.4 Gy/1.8 Gy Fx) Paclitaxel (50mg/m2/weekly X 6) Carboplatin (AUC 2/weekly X 6)

Drug: carboplatin; Drug: paclitaxel; Procedure: conventional surgery; Radiation: radiation therapy

Interventions

carboplatin DRUG

Treatment

paclitaxel DRUG

Treatment

conventional surgery PROCEDURE

Treatment

radiation therapy RADIATION

Treatment

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed, newly diagnosed, unilateral primary non-small cell lung cancer (NSCLC) * Must have involvement of the superior sulcus, chest wall, or mediastinum * Must have at least 1 of the following: * Locally advanced Pancoast tumors with no documented mediastinal or supraclavicular nodal involvement (T3-T4, N0-1) * Resectable chest wall disease (T3, N0-1) * Marginally resectable T4, N0-1, or NX central NSCLC * N2 patients who are potentially resectable after induction chemoradiotherapy * No evidence of extrathoracic spread to liver, adrenals, brain, or bone * No evidence of supraclavicular nodes, malignant pleural or pericardial effusions, or distant metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 1.5 mg/dL * SGOT no greater than 3 times upper limit of normal Renal * Creatinine no greater than 2.0 mg/dL Cardiovascular * No superior vena cava syndrome * No myocardial infarction within the past 6 months * No active uncontrolled congestive heart failure * No active uncontrolled arrhythmia within the past 6 months Pulmonary * FEV1 at least 800 mL Other * No other active invasive malignancy requiring therapy within the past 2 years * No ongoing need for adjuvant therapy * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 3 months after study entry PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * No prior pelvic or thoracic radiotherapy Surgery * See Disease Characteristics Other * Concurrent beta blockers, digitalis derivatives, or channel-blocking agents allowed provided cardiac conditions are stable

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Paclitaxel; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Therapeutics

Results Point of Contact

• Title: Dr. Mark Hallman
• Organization: Fox Chase Cancer Center

Mark.Hallman@fccc.edu

215-728-2581

Study Officials

• Aruna J. Turaka, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

• Mark Hallman, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: August 5, 2002
• First Posted: May 7, 2003
• Study Start: July 1, 2002
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2018
• Last Updated: February 3, 2022
• Results First Posted: February 3, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)