Lung CancerPhase 3NCT00003240
Standard Therapy Given With or Without Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer
A Phase 3 study testing cisplatin, ifosfamide and mitomycin C in people with Lung Cancer, run by National Cancer Institute (NCI) at 1 site 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 known whether giving chemotherapy in addition to standard therapy is a more effective treatment for lung cancer. 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, ifosfamide and mitomycin C
- Type of treatment
- Surgery or procedure
- How many people
- 1,800 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 1995to not given
- 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 confirmed non-small cell lung cancer being treated with primary surgery, radical radiotherapy, surgery plus radiotherapy, or best supportive care
PATIENT CHARACTERISTICS: Age: Adult Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: No inadequate renal function Other: No other prior or concurrent malignancy within the past 3 years except nonmelanoma skin cancer Must be fit enough to receive therapy
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Prior radical radiotherapy allowed Surgery: See Disease Characteristics Prior surgery allowed
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Middlesex Hospital- Meyerstein Institute
London, England, WIT 3AA
About this study
Official title: A Major Randomised Trial to Determine the Value of Cisplatin-Based Chemotherapy For All Patients With Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not known whether giving chemotherapy in addition to standard therapy is a more effective treatment for lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of standard therapy given with or without combination chemotherapy in treating patients with non-small cell lung cancer.
Read the detailed description
OBJECTIVES: I. Assess whether the addition of cisplatin-based chemotherapy to standard treatment improves survival in patients with non-small cell lung cancer.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo primary surgery, radical radiotherapy, radiotherapy with surgery, or best supportive care. Arm II: Patients undergo treatment as in arm I. Beginning within 10 weeks after surgery or radical radiotherapy or as soon as possible after diagnosis, patients receive 1 of the following regimens: Regimen A: Patients receive cisplatin IV on day 1 followed by vindesine on days 1 and 8. Regimen B: Patients receive mitomycin, ifosfamide, and cisplatin on day 1. Regimen C: Patients receive mitomycin, vinblastine, and cisplatin on day 1. Regimen D: Patients receive vinorelbine on days 1 and 8 and cisplatin on day 1. Treatment in all 4 regimens repeats every 3 weeks for 3 courses. Patients are followed at 3 months, 6 months, 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,800 patients will be accrued for this study within 3 years.
- Conditions
- Lung Cancer
- Being tested
- cisplatin, ifosfamide, mitomycin C, vinblastine sulfate, vindesine
- 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 IV 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
ifosfamideDrug
mitomycin CDrug
vinblastine sulfateDrug
vindesineDrug
vinorelbine tartrateDrug
conventional surgeryProcedure or surgery
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2004 (estimated)
- Study startOct 1995
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Stephen G. Spiro, Study chair, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003240
- Sponsor's protocol ID
- CDR0000066115
- Other IDs
- LLCG-BLT, MRC-BLT, EU-98003
- Status last verified
- May 2007
- First submitted
- 1 Nov 1999
- Last updated
- 18 Dec 2013
- Results posted
- No
Publications
Pignon JP, Tribodet H, Scagliotti GV, et al.: Lung Adjuvant Cisplatin Evaluation (LACE): a pooled analysis of five randomized clinical trials including 4,584 patients. [Abstract] J Clin Oncol 24 (Suppl 18): A-7008, 2006.
Brown J, Thorpe H, Napp V, Fairlamb DJ, Gower NH, Milroy R, Parmar MK, Rudd RM, Spiro SG, Stephens RJ, Waller D, West P, Peake MD. Assessment of quality of life in the supportive care setting of the big lung trial in non-small-cell lung cancer. J Clin Oncol. 2005 Oct 20;23(30):7417-27. doi: 10.1200/JCO.2005.09.158. Epub 2005 Sep 12.
PubMed 16157935Fairlamb DJ, Gower N, Milroy R, et al.: The Big Lung Trial (BLT): determining the value of cisplatin-based chemotherapy for all patients with non-small cell lung cancer (NSCLC). Preliminary results in the radical radiotherapy setting. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2570, 639, 2003.
Waller D, Fairlamb DJ, Gower N, et al.: The Big Lung Trial (BLT): determining the value of cisplatin-based chemotherapy for all patients with non-small cell lung cancer (NSCLC). Preliminary results in the surgical setting. [Abstract] Proceedings of the American Society of Clinical Oncology 22 : A-2543, 632, 2003.
Stephens RJ, Gower NH, Spiro SG, et al.: The Big Lung Trial (BLT): a major randomised trial to determine the value of cisplatin-based chemotherapy for all patients with non-small cell lung cancer. [Abstract] Lung Cancer 29 (1 Suppl 1): A-61, 20, 2000.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Major Randomised Trial to Determine the Value of Cisplatin-Based Chemotherapy For All Patients With Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00003240
- Acronym / sponsor ID
- CDR0000066115
- 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 IV non-small cell lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Oct 1995
- First posted
- 20 Feb 2004 (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 known whether giving chemotherapy in addition to standard therapy is a more effective treatment for lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of standard therapy given with or without combination chemotherapy in treating patients with non-small cell lung cancer.
Detailed description
OBJECTIVES: I. Assess whether the addition of cisplatin-based chemotherapy to standard treatment improves survival in patients with non-small cell lung cancer.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo primary surgery, radical radiotherapy, radiotherapy with surgery, or best supportive care. Arm II: Patients undergo treatment as in arm I. Beginning within 10 weeks after surgery or radical radiotherapy or as soon as possible after diagnosis, patients receive 1 of the following regimens: Regimen A: Patients receive cisplatin IV on day 1 followed by vindesine on days 1 and 8. Regimen B: Patients receive mitomycin, ifosfamide, and cisplatin on day 1. Regimen C: Patients receive mitomycin, vinblastine, and cisplatin on day 1. Regimen D: Patients receive vinorelbine on days 1 and 8 and cisplatin on day 1. Treatment in all 4 regimens repeats every 3 weeks for 3 courses. Patients are followed at 3 months, 6 months, 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,800 patients will be accrued for this study within 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
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 | – |
| ifosfamide | Drug | – |
| mitomycin C | Drug | – |
| vinblastine sulfate | Drug | – |
| vindesine | Drug | – |
| vinorelbine tartrate | Drug | – |
| conventional surgery | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
- BackgroundPignon JP, Tribodet H, Scagliotti GV, et al.: Lung Adjuvant Cisplatin Evaluation (LACE): a pooled analysis of five randomized clinical trials including 4,584 patients. [Abstract] J Clin Oncol 24 (Suppl 18): A-7008, 2006.
- Results publication: PubMed 16157935Brown J, Thorpe H, Napp V, Fairlamb DJ, Gower NH, Milroy R, Parmar MK, Rudd RM, Spiro SG, Stephens RJ, Waller D, West P, Peake MD. Assessment of quality of life in the supportive care setting of the big lung trial in non-small-cell lung cancer. J Clin Oncol. 2005 Oct 20;23(30):7417-27. doi: 10.1200/JCO.2005.09.158. Epub 2005 Sep 12.
- Results publicationFairlamb DJ, Gower N, Milroy R, et al.: The Big Lung Trial (BLT): determining the value of cisplatin-based chemotherapy for all patients with non-small cell lung cancer (NSCLC). Preliminary results in the radical radiotherapy setting. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2570, 639, 2003.
- Results publicationWaller D, Fairlamb DJ, Gower N, et al.: The Big Lung Trial (BLT): determining the value of cisplatin-based chemotherapy for all patients with non-small cell lung cancer (NSCLC). Preliminary results in the surgical setting. [Abstract] Proceedings of the American Society of Clinical Oncology 22 : A-2543, 632, 2003.
- Results publicationStephens RJ, Gower NH, Spiro SG, et al.: The Big Lung Trial (BLT): a major randomised trial to determine the value of cisplatin-based chemotherapy for all patients with non-small cell lung cancer. [Abstract] Lung Cancer 29 (1 Suppl 1): A-61, 20, 2000.
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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.
Stephen G. Spiro study chair
University College London Hospitals
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 cisplatin, ifosfamide and mitomycin C in people with Lung Cancer, run by National Cancer Institute (NCI) 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: status not confirmed, as of the sponsor's last update on 18 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 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?
Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003240, which also lists 5 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 18 Dec 2013.