Cisplatin, Vinorelbine, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery

NCT00309972 | Completed Phase 3 DMC

• 5 other identifiers: CDR0000465629C11922/A455813746987EU-206022004-001920-19
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving combination chemotherapy followed by radiation therapy is more effective than giving combination chemotherapy together with radiation therapy followed by more chemotherapy in treating non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying combination chemotherapy followed by radiation therapy to see how well it works compared to combination chemotherapy combined with radiation therapy followed by more chemotherapy in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Treatment related mortality (any cause)

  from randomization till death

Secondary Outcomes (6)

• Hematological, pulmonary, esophageal, and neurological toxicities

  From randomisation to the first 6 months

• Quality of life

  at baseline, every 3 weeks for the first 6 months, then 3 monthly until 2 years, 6 monthly until 3 years, and annually thereafter

• Cost effectiveness

  at baseline, every 3 weeks for the first 6 months, then 3 monthly until 2 years, 6 monthly until 3 years, and annually thereafter

• Overall survival and progression-free survival.

  Overall Survival is the time between date of randomisation and date of death of any cause. Progression-free survival will be calculated from the date of randomisation to the date of first clinical evidence of progressive disease, or death.

• Local progression-free survival (local control)

  From the date of randomisation to the date of first clinical evidence of progressive disease at the primary site, or death

Study Arms (2)

Sequential arm (SEQ)

ACTIVE COMPARATOR

Four cycles of cisplatinum/vinorelbine given in a 21 day cycle followed by radical radiotherapy, 55 Gy in 20 once daily fractions in four weeks (2.75 Gy/day).

Drug: Control arm (SEQ):

Experimental arm (CON)

EXPERIMENTAL

Concurrent chemo-radiotherapy \[55 Gy in 20 daily fractions in 4 weeks (2.75 Gy/day) with cisplatinum given concurrently with fractions 1-4 and 16-19, and vinorelbine prior to fractions 1, 6, 15 and 20\] followed by two cycles of cisplatinum/vinorelbine.

Drug: Experimental arm (CON):

Interventions

Control arm (SEQ): DRUG

Four cycles of cisplatinum/vinorelbine given in a 21 day cycle followed by radical radiotherapy, 55 Gy in 20 once daily fractions in four weeks (2.75 Gy/day).

Sequential arm (SEQ)

Experimental arm (CON): DRUG

concurrent chemo-radiotherapy \[55 Gy in 20 daily fractions in 4 weeks (2.75 Gy/day) with cisplatinum given concurrently with fractions 1-4 and 16-19, and vinorelbine prior to fractions 1, 6, 15 and 20\] followed by two cycles of cisplatinum/vinorelbine.

Experimental arm (CON)

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed stage III non-small cell lung cancer (NSCLC) * Patients with stage IIIB disease must not have a pleural effusion that is cytologically proven to be malignant * Inoperable disease * Disease must be able to be encompassed within a radical radiotherapy treatment volume PATIENT CHARACTERISTICS: * ECOG performance status 0 or 1 * Life expectancy \> 3 months * Patient considered able to tolerate platinum-based chemotherapy and radical radiotherapy * Glomerular filtration rate ≥ 60 mL/min * WBC \> 3,000/mm³ * Absolute neutrophil count \> 1,500/mm³ * Hemoglobin \> 10.0 g/dL * Patients with hemoglobin between 10 and 12 g/dL at randomization require a blood transfusion to ensure hemoglobin \> 12 g/dL before starting radiotherapy * Platelet count \> 100,000/mm³ * FEV\_1 ≥ 1.0 L or DLCO (transfer factor) ≥ 50% of predicted * Alkaline phosphatase ≤ 1.5 times upper limit of normal (ULN) * Gamma-glutamyl-transferase \< 1.5 times ULN * Transaminases ≤ 1.5 times ULN * Bilirubin ≤ 1.5 times ULN * No medically unstable conditions (e.g., unstable diabetes, uncontrolled arterial hypertension, infection, hypercalcemia, or ischemic heart disease) * Not pregnant or nursing * Fertile patients must agree to use effective contraception * Negative pregnancy test * No other previous or current malignant disease likely to interfere with protocol treatment or comparisons PRIOR CONCURRENT THERAPY: * No prior chemotherapy, radiotherapy, or investigational agents

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

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

Clatterbridge Centre for Oncology

Merseyside, England, CH63 4JY, United Kingdom

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Officials

• Joe Maguire, MD

  Clatterbridge Centre for Oncology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2006
• First Posted: April 3, 2006
• Study Start: December 1, 2005
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2012
• Last Updated: December 3, 2014

Record last verified: 2012-03

Locations

GB (1)