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

December 1, 2014 updated by: University College, London

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment related mortality (any cause)
Time Frame: from randomization till death
from randomization till death

Secondary Outcome Measures

Outcome Measure
Time Frame
Hematological, pulmonary, esophageal, and neurological toxicities
Time Frame: From randomisation to the first 6 months
From randomisation to the first 6 months
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
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
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
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.
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.
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)
Time Frame: From the date of randomisation to the date of first clinical evidence of progressive disease at the primary site, or death
From the date of randomisation to the date of first clinical evidence of progressive disease at the primary site, or death
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.
proportion of patients in each treatment group whose best response in the first 6 months from randomisation is complete or partial will be reported.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Investigators

  • Study Chair: Joe Maguire, MD, Clatterbridge Centre for Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (ACTUAL)

February 1, 2011

Study Completion (ACTUAL)

February 1, 2012

Study Registration Dates

First Submitted

March 29, 2006

First Submitted That Met QC Criteria

March 29, 2006

First Posted (ESTIMATE)

April 3, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000465629
  • C11922/A4558 (OTHER_GRANT: Cancer Research UK)
  • 13746987 (OTHER: ISRCTN)
  • EU-20602 (OTHER: UCL CTC)
  • 2004-001920-19 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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