Lung CancerPhase 3SOCCARNCT00309972
Cisplatin, Vinorelbine, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery
A Phase 3 study testing Experimental arm (CON): in people with Lung Cancer, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Experimental arm (CON):
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2005to Feb 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clatterbridge Centre for Oncology
Merseyside, England, CH63 4JY
About this study
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
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Control arm (SEQ):, Experimental arm (CON):
- Keywords
- stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Drug: Experimental arm (CON): |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment related mortality (any cause)
Measured: from randomization till death
Secondary outcomes (6)
Hematological, pulmonary, esophageal, and neurological toxicities
Measured: From randomisation to the first 6 months
Quality of life
Measured: 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
Measured: 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.
Measured: 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)
Measured: From the date of randomisation to the date of first clinical evidence of progressive disease at the primary site, or death
Response
Measured: proportion of patients in each treatment group whose best response in the first 6 months from randomisation is complete or partial will be reported.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2006 (estimated)
- Study startDec 2005
- Primary completionFeb 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joe Maguire, MD, Study chair, Clatterbridge Centre for Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00309972
- Sponsor's protocol ID
- CDR0000465629
- Other IDs
- C11922/A4558, 13746987, EU-20602, 2004-001920-19, 2004
- Acronym
- SOCCAR
- Status last verified
- Mar 2012
- First submitted
- 29 Mar 2006
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00309972
- Acronym / sponsor ID
- SOCCAR / CDR0000465629
- Conditions
- Lung Cancer
- Keywords
- stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 3 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequential arm (SEQ) | Active comparator | 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 arm (CON) | Experimental | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Drug | Sequential arm (SEQ) |
| 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) |
Primary outcome
Treatment related mortality (any cause)
Time frame: from randomization till death
6 secondary outcomes
Hematological, pulmonary, esophageal, and neurological toxicities
Time frame: 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
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
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.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joe Maguire, MD study chair
Clatterbridge Centre for Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental arm (CON): in people with Lung Cancer, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment related mortality (any cause) (time frame: from randomization till death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.