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

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Drug: Control arm (SEQ): Drug: Experimental arm (CON):	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized Phase III Trial of Sequential Chemotherapy Followed By Radical Radiotherapy Versus Concurrent Chemo-Radiotherapy Followed by Chemotherapy in Patients With Inoperable Stage III Non-Small Cell Lung Cancer and Good Performance Status

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Vinorelbine Vinorelbine tartrate

U.S. FDA Resources

Further study details as provided by University College, London:

Primary Outcome Measures:

Treatment related mortality (any cause) [ Time Frame: from randomization till death ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hematological, pulmonary, esophageal, and neurological toxicities [ Time Frame: From randomisation to the first 6 months ] [ Designated as safety issue: Yes ]
Quality of life [ Time Frame: at baseline, every 3 weeks for the first 6 months, then 3 monthly until 2 years, 6 monthly until 3 years, and annually thereafter ] [ Designated as safety issue: No ]
Cost effectiveness [ Time Frame: at baseline, every 3 weeks for the first 6 months, then 3 monthly until 2 years, 6 monthly until 3 years, and annually thereafter ] [ Designated as safety issue: No ]
Overall survival and progression-free survival. [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
Local progression-free survival (local control) [ Time Frame: From the date of randomisation to the date of first clinical evidence of progressive disease at the primary site, or death ] [ Designated as safety issue: Yes ]
Response [ Time Frame: proportion of patients in each treatment group whose best response in the first 6 months from randomisation is complete or partial will be reported. ] [ Designated as safety issue: Yes ]

Enrollment:	130
Study Start Date:	December 2005
Estimated Study Completion Date:	December 2012
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Sequential arm (SEQ) 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): 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).
Experimental: Experimental arm (CON) 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): 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.

Detailed Description:

OBJECTIVES:

Primary

Compare the overall survival of patients with stage III non-small cell cancer treated with chemotherapy comprising cisplatin and vinorelbine ditartrate (CV) followed by radical radiotherapy versus concurrent CV chemoradiotherapy followed by CV chemotherapy.

Secondary

Compare the progression-free survival of patients treated with these regimens.
Compare the local progression-free survival (local control).
Compare the hematological, pulmonary, esophageal, and neurological toxicities.
Compare the response.
Compare the quality of life.
Compare the cost-effectiveness.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to clinically important factors. Patients are randomized to 1 of 2 treatment arms.

Arm I (sequential treatment): Patients receive cisplatin IV over 2 hours on day 1 and vinorelbine ditartrate IV over 5-10 minutes on days 1 and 8. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 15, patients undergo radiotherapy 5 days a week for 4 weeks.
Arm II (concurrent treatment): Patients undergo radiotherapy as in arm I beginning in week 1. Patients receive cisplatin IV over 2 hours on days 1-4 and vinorelbine ditartrate IV over 5-10 minutes on days 1 and 8. Chemotherapy repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, monthly for 6 months, and then at each follow-up visit.

After completion of study treatment, patients are followed periodically.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 508 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309972

Locations

United Kingdom
Clatterbridge Centre for Oncology
Merseyside, England, United Kingdom, CH63 4JY

Sponsors and Collaborators

University College, London

Investigators

Study Chair:

Joe Maguire, MD

Clatterbridge Centre for Oncology

More Information

Additional Information:

SOCCAR: Sequential or concurrent chemotherapy and hypofractionated accelerated radiotherapy in inoperable stage III NSCLC. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University College, London
ClinicalTrials.gov Identifier:	NCT00309972 History of Changes
Other Study ID Numbers:	CDR0000465629, C11922/A4558, 13746987, EU-20602, 2004-001920-19
Study First Received:	March 29, 2006
Last Updated:	March 15, 2012
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: Research Ethics Committee

Keywords provided by University College, London:

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

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases

Respiratory Tract Diseases
Vinorelbine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 21, 2013

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