Lung CancerPhase 3NCT00003159
Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-small Cell Lung Cancer
A Phase 3 study testing carboplatin, cisplatin and docetaxel in people with Lung Cancer, run by Medical Research Council at 2 sites in United Kingdom.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if surgery is more effective with or without preoperative chemotherapy in treating non-small cell lung cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer
- What is being tested?
- carboplatin, cisplatin and docetaxel
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Aug 1997to Jun 2007
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically proven non-small cell lung cancer
- Resectable disease
- Previously untreated disease
- No evidence of distant metastases
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- WHO 0-2
Life expectancy:
- Not specified
Hematopoietic:
- WBC greater than 3,000/mm^3
- Neutrophil count greater than 1,500/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- Considered fit for chemotherapy and surgical resection
- No other disease or prior malignancy that would preclude study treatment
- No active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent prophylactic colony-stimulating factors (except for secondary prophylaxis)
- No concurrent immunotherapy
Chemotherapy:
- Not specified
Endocrine therapy:
- No concurrent hormonal agents, except corticosteroids
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No other concurrent anticancer therapy
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Medical Research Council Clinical Trials Unit
London, England, NW1 2DA
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, SM2 5PT
About this study
Official title: Randomized Trial of Surgical Resection With or Without Pre-Operative Chemotherapy in Patients With Operable Non-Small Cell Lung Cancer (NSCLC) of Any Stage
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if surgery is more effective with or without preoperative chemotherapy in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying surgery and preoperative chemotherapy to see how well they work compared to surgery alone in treating patients with resectable non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- Compare the survival of patients with resectable non-small cell lung cancer treated with surgery with or without preoperative chemotherapy.
Secondary
- Compare the quality of life of patients treated with these regimens.
- Compare pre-randomization clinical and post-surgical pathological staging in patients treated with these regimens.
- Compare resectability rates in patients treated with these regimens.
- Compare time to and site of relapse in patients treated with these regimens.
- Determine response in patients treated with preoperative chemotherapy.
- Determine the adverse effects of preoperative chemotherapy in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo surgical resection no more than 4 weeks after randomization.
- Arm II: Patients receive one of the following chemotherapy regimens immediately after randomization:
- Regimen 1: Patients receive mitomycin IV, vinblastine IV, and cisplatin IV on day 1.
- Regimen 2: Patients receive mitomycin IV, ifosfamide IV over 3 hours, and cisplatin IV over 1 hour on day 1.
- Regimen 3: Patients receive cisplatin IV over 2 hours on day 1 and vinorelbine IV over 5 -10 minutes on days 1 and 8.
- Regimen 4: Patients receive paclitaxel IV and carboplatin IV on day 1.
- Regimen 5: Patients receive gemcitabine IV on days 1 and 8 and cisplatin IV over 2 hours on day 1.
- Regimen 6: Patients receive docetaxel IV and carboplatin IV on day 1. In all regimens, treatment repeats every 3 weeks for a total of 3 courses. Patients undergo surgical resection at least 4 weeks after the last course of chemotherapy.
Quality of life is assessed at 6 and 12 months and then annually thereafter.
Patients are followed 1 month after surgery, 6 months after randomization, every 3 months for 2 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study.
- Conditions
- Lung Cancer
- Being tested
- carboplatin, cisplatin, docetaxel, gemcitabine hydrochloride, ifosfamide
- 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, stage 0 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.
carboplatinDrug
cisplatinDrug
docetaxelDrug
ifosfamideDrug
mitomycin CDrug
paclitaxelDrug
vinblastine sulfateDrug
vinorelbine tartrateDrug
conventional surgeryProcedure or surgery
neoadjuvant therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Secondary outcomes (7)
Quality of life as measured by SF-36 questionnaire at baseline, 6 months, 12 months, and then annually thereafter
Clinical and post-surgery pathological staging at pre-randomization
Resectability rates
Extent of surgery
Time to and site of relapse
Tumor response to chemotherapy
Adverse effects of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startAug 1997
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Research Council
- Sponsor type
- Other government
- Investigators
- Adrian Hodson, Medical Research CouncilIan E. Smith, MD, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003159
- Sponsor's protocol ID
- CDR0000065952
- Other IDs
- MRC-LU22, EORTC-08012, EU-97016, ISRCTN25582437
- Status last verified
- May 2005
- First submitted
- 1 Nov 1999
- Last updated
- 4 Dec 2013
- Results posted
- No
Publications
Gilligan D, Nicolson M, Smith I, Groen H, Dalesio O, Goldstraw P, Hatton M, Hopwood P, Manegold C, Schramel F, Smit H, van Meerbeeck J, Nankivell M, Parmar M, Pugh C, Stephens R. Preoperative chemotherapy in patients with resectable non-small cell lung cancer: results of the MRC LU22/NVALT 2/EORTC 08012 multicentre randomised trial and update of systematic review. Lancet. 2007 Jun 9;369(9577):1929-37. doi: 10.1016/S0140-6736(07)60714-4.
PubMed 17544497Hopwood P, Nankivell M, Pugh C, et al.: Impact of pre-operative chemotherapy on the quality of life (QL) of patients with resectable non-small cell lung cancer (NSCLC): experience from the MRC LU22/NVALT/EORTC 08012 multicentre randomised trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-9020, 498s, 2007.
Nicolson M, Gilligan D, Smith I, et al.: Pre-operative chemotherapy in patients with resectable non-small cell lung cancer (NSCLC): first results of the MRC LU22/NVALT/EORTC 08012 multi-centre randomised trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-7518, 389s, 2007.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Surgical Resection With or Without Pre-Operative Chemotherapy in Patients With Operable Non-Small Cell Lung Cancer (NSCLC) of Any Stage
- ClinicalTrials.gov ID
- NCT00003159
- Acronym / sponsor ID
- CDR0000065952
- 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, stage 0 non-small cell lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Medical Research CouncilOther government
- Collaborators
- European Organisation for Research and Treatment of Cancer - EORTC
- Study start
- Aug 1997
- Study completion
- Jun 2007 (actual)
- First posted
- 27 Jan 2003 (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 use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if surgery is more effective with or without preoperative chemotherapy in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying surgery and preoperative chemotherapy to see how well they work compared to surgery alone in treating patients with resectable non-small cell lung cancer.
Detailed description
OBJECTIVES:
Primary
- Compare the survival of patients with resectable non-small cell lung cancer treated with surgery with or without preoperative chemotherapy.
Secondary
- Compare the quality of life of patients treated with these regimens.
- Compare pre-randomization clinical and post-surgical pathological staging in patients treated with these regimens.
- Compare resectability rates in patients treated with these regimens.
- Compare time to and site of relapse in patients treated with these regimens.
- Determine response in patients treated with preoperative chemotherapy.
- Determine the adverse effects of preoperative chemotherapy in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo surgical resection no more than 4 weeks after randomization.
- Arm II: Patients receive one of the following chemotherapy regimens immediately after randomization:
- Regimen 1: Patients receive mitomycin IV, vinblastine IV, and cisplatin IV on day 1.
- Regimen 2: Patients receive mitomycin IV, ifosfamide IV over 3 hours, and cisplatin IV over 1 hour on day 1.
- Regimen 3: Patients receive cisplatin IV over 2 hours on day 1 and vinorelbine IV over 5 -10 minutes on days 1 and 8.
- Regimen 4: Patients receive paclitaxel IV and carboplatin IV on day 1.
- Regimen 5: Patients receive gemcitabine IV on days 1 and 8 and cisplatin IV over 2 hours on day 1.
- Regimen 6: Patients receive docetaxel IV and carboplatin IV on day 1. In all regimens, treatment repeats every 3 weeks for a total of 3 courses. Patients undergo surgical resection at least 4 weeks after the last course of chemotherapy.
Quality of life is assessed at 6 and 12 months and then annually thereafter.
Patients are followed 1 month after surgery, 6 months after randomization, every 3 months for 2 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| carboplatin | Drug | – |
| cisplatin | Drug | – |
| docetaxel | Drug | – |
| gemcitabine hydrochloride | Drug | – |
| ifosfamide | Drug | – |
| mitomycin C | Drug | – |
| paclitaxel | Drug | – |
| vinblastine sulfate | Drug | – |
| vinorelbine tartrate | Drug | – |
| conventional surgery | Procedure or surgery | – |
| neoadjuvant therapy | Procedure or surgery | – |
Primary outcome
Survival
7 secondary outcomes
Quality of life as measured by SF-36 questionnaire at baseline, 6 months, 12 months, and then annually thereafter
Clinical and post-surgery pathological staging at pre-randomization
Resectability rates
Extent of surgery
Time to and site of relapse
Tumor response to chemotherapy
Adverse effects of chemotherapy
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 4 Dec 2013.
- Results publication: PubMed 17544497Gilligan D, Nicolson M, Smith I, Groen H, Dalesio O, Goldstraw P, Hatton M, Hopwood P, Manegold C, Schramel F, Smit H, van Meerbeeck J, Nankivell M, Parmar M, Pugh C, Stephens R. Preoperative chemotherapy in patients with resectable non-small cell lung cancer: results of the MRC LU22/NVALT 2/EORTC 08012 multicentre randomised trial and update of systematic review. Lancet. 2007 Jun 9;369(9577):1929-37. doi: 10.1016/S0140-6736(07)60714-4.
- Results publicationHopwood P, Nankivell M, Pugh C, et al.: Impact of pre-operative chemotherapy on the quality of life (QL) of patients with resectable non-small cell lung cancer (NSCLC): experience from the MRC LU22/NVALT/EORTC 08012 multicentre randomised trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-9020, 498s, 2007.
- Results publicationNicolson M, Gilligan D, Smith I, et al.: Pre-operative chemotherapy in patients with resectable non-small cell lung cancer (NSCLC): first results of the MRC LU22/NVALT/EORTC 08012 multi-centre randomised trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-7518, 389s, 2007.
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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.
Adrian Hodson
Medical Research Council
Ian E. Smith, MD
Royal Marsden NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing carboplatin, cisplatin and docetaxel in people with Lung Cancer, run by Medical Research Council at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 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 2 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 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?
Survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003159, which also lists 3 linked publications.
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 4 Dec 2013.