Lung CancerPhase 2/3NCT00253591
Radiation Therapy With or Without Vinorelbine and Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
A Phase 2/3 study testing cisplatin, vinorelbine tartrate and radiation therapy in people with Lung Cancer, run by Medical Research Council at 20 sites in United Kingdom.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as vinorelbine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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?
- cisplatin, vinorelbine tartrate and radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 20 sitesUnited Kingdom
- Study dates
- Jun 2005to Dec 2009
- Phase
- Phase 2/3
- 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 I-III non-small cell lung cancer
- Inoperable or patient refuses surgery
- Disease can be encompassed within the radical radiotherapy treatment volume
PATIENT CHARACTERISTICS:
Performance status
- ECOG 0-1
Life expectancy
- More than 3 months
Hematopoietic
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3
Hepatic
- Bilirubin < 1.5 times upper limit of normal
Renal
- Glomerular filtration rate > 60 mL/min
Cardiovascular
- No uncontrolled arterial hypertension
- No ischemic heart disease
Pulmonary
- FEV_1 > 50% of predicted OR
- DLCO > 50% of predicted
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior or current malignancy that would preclude study treatment
- Medically stable
- No unstable diabetes
- No infection
- No hypercalcemia
PRIOR CONCURRENT THERAPY:
Chemotherapy
- No prior chemotherapy
Radiotherapy
- See Disease Characteristics
- No prior radiotherapy
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United Kingdom20 sites
Wansbeck General Hospital
Ashington, England, NE63 9JJ
Bristol Haematology and Oncology Centre
Bristol, England, BS2 8ED
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, CF14 2TL
Cheltenham General Hospital
Cheltenham, England, GL53 7AN
Derbyshire Royal Infirmary
Derby, England, DE1 2QY
University Hospital of North Durham
Durham, England, DH1 5TW
Queen Elizabeth Hospital
Gateshead, England, NE9 6SX
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, G12 0YN
Crosshouse Hospital
Kilmarnock, Scotland, KA2 OBE
Llandough Hospital
Llandough, Wales, CF64 2XX
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
Royal Gwent Hospital
Newport Gwent, Wales, NP9 2UB
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, HA6 2RN
Nottingham City Hospital NHS Trust
Nottingham, England, NG5 1PB
Kings Mill Hospital
Nottinghamshire, England, NG17 4JL
Churchill Hospital
Oxford, England, OX3 7LJ
Cancer Research Centre at Weston Park Hospital
Sheffield, England, S1O 2SJ
Great Western Hospital
Swindon, England, SN3 6BB
Worcester Royal Hospital
Worcester, England, WR5 1DD
Yeovil District Hospital
Yeovil, England, BA21 4AT
About this study
Official title: Randomised Phase II/III Trial of Induction Chemotherapy Followed by Continuous Hyperfractionated Accelerated Radiotherapy (CHART) Versus CHART Alone in Patients With Inoperable Non-Small Cell Lung Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as vinorelbine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation therapy together with vinorelbine and cisplatin is more effective than radiation therapy alone in treating non-small cell lung cancer.
PURPOSE: This randomized phase II/III trial is studying how well giving radiation therapy together with vinorelbine and cisplatin works and compares it to radiation therapy alone in treating patients with stage I, stage II, or stage III non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- Compare the overall survival of patients with stage I-III non-small cell lung cancer treated with vinorelbine, cisplatin, and continuous hyperfractionated accelerated radiotherapy (CHART) vs CHART alone.
Secondary
- Compare the response, progression-free survival, and quality of life of patients treated with these regimens.
- Compare the toxic effect of these regimens in these patients.
- Compare the cost effectiveness of these regimens in these patients.
- Compare the local and distant control in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo continuous hyperfractionated accelerated radiotherapy (CHART) 3 times a day for 12 consecutive days.
- Arm II: Patients receive vinorelbine IV over 5-10 minutes on days 1 and 8 and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 4-6 weeks later, patients undergo CHART as in arm I.
Quality of life is assessed periodically.
After completion of study treatment, patients are evaluated periodically for at least 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.
- Conditions
- Lung Cancer
- Being tested
- cisplatin, vinorelbine tartrate, radiation therapy
- Keywords
- stage I non-small cell lung cancer, stage II non-small cell lung cancer, 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.
cisplatinDrug
vinorelbine tartrateDrug
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Secondary outcomes (4)
Progression-free survival
Toxicity
Response (complete or partial response)
Cost effectiveness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startJun 2005
- Primary completionDec 2007
- Study completionDec 2009
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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Research Council
- Sponsor type
- Other government
- Investigators
- Matthew Hatton, MD, Study chair, Cancer Research Centre at Weston Park Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253591
- Sponsor's protocol ID
- CDR0000449972
- Other IDs
- MRC-LU23, EU-20535, EU-INCH-20535, EudraCT-2004-004438-15
- Status last verified
- Jul 2007
- First submitted
- 11 Nov 2005
- Last updated
- 19 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Phase II/III Trial of Induction Chemotherapy Followed by Continuous Hyperfractionated Accelerated Radiotherapy (CHART) Versus CHART Alone in Patients With Inoperable Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00253591
- Acronym / sponsor ID
- CDR0000449972
- Conditions
- Lung Cancer
- Keywords
- stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Medical Research CouncilOther government
- Study start
- Jun 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 15 Nov 2005 (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: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as vinorelbine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation therapy together with vinorelbine and cisplatin is more effective than radiation therapy alone in treating non-small cell lung cancer.
PURPOSE: This randomized phase II/III trial is studying how well giving radiation therapy together with vinorelbine and cisplatin works and compares it to radiation therapy alone in treating patients with stage I, stage II, or stage III non-small cell lung cancer.
Detailed description
OBJECTIVES:
Primary
- Compare the overall survival of patients with stage I-III non-small cell lung cancer treated with vinorelbine, cisplatin, and continuous hyperfractionated accelerated radiotherapy (CHART) vs CHART alone.
Secondary
- Compare the response, progression-free survival, and quality of life of patients treated with these regimens.
- Compare the toxic effect of these regimens in these patients.
- Compare the cost effectiveness of these regimens in these patients.
- Compare the local and distant control in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo continuous hyperfractionated accelerated radiotherapy (CHART) 3 times a day for 12 consecutive days.
- Arm II: Patients receive vinorelbine IV over 5-10 minutes on days 1 and 8 and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 4-6 weeks later, patients undergo CHART as in arm I.
Quality of life is assessed periodically.
After completion of study treatment, patients are evaluated periodically for at least 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
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 |
|---|---|---|
| cisplatin | Drug | – |
| vinorelbine tartrate | Drug | – |
| radiation therapy | Radiation | – |
Primary outcome
Overall survival
4 secondary outcomes
Progression-free survival
Toxicity
Response (complete or partial response)
Cost effectiveness
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 19 Dec 2013.
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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.
Matthew Hatton, MD study chair
Cancer Research Centre at Weston Park Hospital
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing cisplatin, vinorelbine tartrate and radiation therapy in people with Lung Cancer, run by Medical Research Council at 20 sites 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 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Overall survival. 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 19 Dec 2013.