Lung CancerPhase 3NCT00002822
Combination Chemotherapy Followed by Radiation Therapy in Patients With Small Cell Lung Cancer
A Phase 3 study testing carboplatin, cisplatin and cyclophosphamide in people with Lung Cancer, run by Medical Research Council 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. Combining more than one drug is a way to kill more tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. 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 cyclophosphamide
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 1996to Nov 2005
- 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:
- Microscopically proven small cell lung cancer
- Diagnosis based on bronchial, mediastinal, pleural, lung, or lymph node biopsy, sputum cytology, or bronchial brushing or fine needle aspirate cytology
- No pleural fluid cytology
- No prior therapy
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- WHO 0-2
Hematopoietic:
- WBC more than 3,000
- ANC more than 1,500
- Platelets more than 100,000
Hepatic/Renal:
- Alkaline phosphatase, aminotransferase, sodium, and LDH normal or no more than 1 of them abnormal
- Creatinine or urea normal
- Creatinine clearance or GFR more than 65 mL/min
Other:
- No clinical evidence of infection
- No prior or concurrent malignancy that interferes with protocol treatments or comparisons
- No other condition that contraindicates treatment
- Willing and able to complete quality-of-life questionnaires
- Hospital Anxiety and Depression Scale, Rotterdam Symptom Checklist, and EORTC questionnaires completed prior to randomization
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- See Disease Characteristics
Radiotherapy:
- See Disease Characteristics
Surgery:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Medical Research Council Clinical Trials Unit
London, England, NW1 2DA
About this study
Official title: RANDOMISED CLINICAL TRIAL OF IFOSFAMIDE, CARBOPLATIN AND ETOPOSIDE WITH MID-CYCLE VINCRISTINE (VICE) VERSUS STANDARD PRACTICE CHEMOTHERAPY IN PATIENTS WITH LIMITED STAGE SMALL CELL LUNG CANCER (SCLC) AND GOOD PERFORMANCE STATUS
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug is a way to kill more tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effect of two combination chemotherapy regimens followed by radiation therapy in treating patients with small cell lung cancer.
Read the detailed description
OBJECTIVES:
- Compare the survival rate in patients with newly diagnosed small cell lung cancer and good performance status treated with an intensive regimen of ifosfamide/carboplatin/etoposide with mid-cycle vincristine (VICE) vs. standard chemotherapy followed, as feasible, by thoracic radiotherapy.
- Compare the adverse effects of treatment and quality of life (including psychological distress, physical status, and functional status and global quality of life) in these patients.
- Compare the Rotterdam Symptom Checklist vs. the EORTC QLQ-C30 and LC13 quality-of-life questionnaires in relation to compliance and ability to detect differences between treatments.
OUTLINE: This is a randomized study.
The first group receives standard combination chemotherapy with doxorubicin/cyclophosphamide/etoposide (ACE) or cisplatin/etoposide (PE) every 3 weeks for 6 courses.
The second group receives intensive combination chemotherapy with carboplatin/ifosfamide/etoposide on days 1-3 with vincristine on day 14 (VICE). Courses repeat every 4 weeks for 6 courses.
Patients in both groups are considered for thoracic radiotherapy beginning 4-5 weeks after the first day of the last course of chemotherapy.
Concurrent prophylactic antibiotics should be given. Patients who relapse may receive further treatment at the clinician's option.
Patients are followed monthly for 6 months, every 2 months for up to 1 year, every 3 months for up to 2 years, every 6 months for 5 years, and annually thereafter.
PROJECTED ACCRUAL: A total of 400 patients will be entered over 3 years.
- Conditions
- Lung Cancer
- Being tested
- carboplatin, cisplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide
- Keywords
- limited stage small cell lung cancer, extensive stage small cell lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
cisplatinDrug
cyclophosphamideDrug
etoposideDrug
ifosfamideDrug
mesnaDrug
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2003 (estimated)
- Study startMar 1996
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Research Council
- Sponsor type
- Other government
- Investigators
- David J. Girling, MD, Study chair, Medical Research Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002822
- Sponsor's protocol ID
- CDR0000064998
- Other IDs
- MRC-LU21, EU-96019
- Status last verified
- Dec 2000
- First submitted
- 1 Nov 1999
- Last updated
- 19 Dec 2013
- Results posted
- No
Publications
Thatcher N, Qian W, Clark PI, Hopwood P, Sambrook RJ, Owens R, Stephens RJ, Girling DJ. Ifosfamide, carboplatin, and etoposide with midcycle vincristine versus standard chemotherapy in patients with small-cell lung cancer and good performance status: clinical and quality-of-life results of the British Medical Research Council multicenter randomized LU21 trial. J Clin Oncol. 2005 Nov 20;23(33):8371-9. doi: 10.1200/JCO.2004.00.9969.
PubMed 16293867Thatcher N, Qian W, Girling DJ: Ifosfamide, carboplatin and etoposide with mid-cycle vincristine (ICE-V) versus standard chemotherapy (C) in patients with small cell lung cancer (SCLC) and good performance status (PS): results of an MRC randomized trial (LU21). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2489, 619, 2003.
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 CLINICAL TRIAL OF IFOSFAMIDE, CARBOPLATIN AND ETOPOSIDE WITH MID-CYCLE VINCRISTINE (VICE) VERSUS STANDARD PRACTICE CHEMOTHERAPY IN PATIENTS WITH LIMITED STAGE SMALL CELL LUNG CANCER (SCLC) AND GOOD PERFORMANCE STATUS
- ClinicalTrials.gov ID
- NCT00002822
- Acronym / sponsor ID
- CDR0000064998
- Conditions
- Lung Cancer
- Keywords
- limited stage small cell lung cancer, extensive stage small cell lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Medical Research CouncilOther government
- Study start
- Mar 1996
- Study completion
- Nov 2005 (actual)
- First posted
- 16 Apr 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. Combining more than one drug is a way to kill more tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effect of two combination chemotherapy regimens followed by radiation therapy in treating patients with small cell lung cancer.
Detailed description
OBJECTIVES:
- Compare the survival rate in patients with newly diagnosed small cell lung cancer and good performance status treated with an intensive regimen of ifosfamide/carboplatin/etoposide with mid-cycle vincristine (VICE) vs. standard chemotherapy followed, as feasible, by thoracic radiotherapy.
- Compare the adverse effects of treatment and quality of life (including psychological distress, physical status, and functional status and global quality of life) in these patients.
- Compare the Rotterdam Symptom Checklist vs. the EORTC QLQ-C30 and LC13 quality-of-life questionnaires in relation to compliance and ability to detect differences between treatments.
OUTLINE: This is a randomized study.
The first group receives standard combination chemotherapy with doxorubicin/cyclophosphamide/etoposide (ACE) or cisplatin/etoposide (PE) every 3 weeks for 6 courses.
The second group receives intensive combination chemotherapy with carboplatin/ifosfamide/etoposide on days 1-3 with vincristine on day 14 (VICE). Courses repeat every 4 weeks for 6 courses.
Patients in both groups are considered for thoracic radiotherapy beginning 4-5 weeks after the first day of the last course of chemotherapy.
Concurrent prophylactic antibiotics should be given. Patients who relapse may receive further treatment at the clinician's option.
Patients are followed monthly for 6 months, every 2 months for up to 1 year, every 3 months for up to 2 years, every 6 months for 5 years, and annually thereafter.
PROJECTED ACCRUAL: A total of 400 patients will be entered over 3 years.
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 | – |
| cyclophosphamide | Drug | – |
| doxorubicin hydrochloride | Drug | – |
| etoposide | Drug | – |
| ifosfamide | Drug | – |
| mesna | Drug | – |
| vincristine sulfate | Drug | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
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.
- Results publication: PubMed 16293867Thatcher N, Qian W, Clark PI, Hopwood P, Sambrook RJ, Owens R, Stephens RJ, Girling DJ. Ifosfamide, carboplatin, and etoposide with midcycle vincristine versus standard chemotherapy in patients with small-cell lung cancer and good performance status: clinical and quality-of-life results of the British Medical Research Council multicenter randomized LU21 trial. J Clin Oncol. 2005 Nov 20;23(33):8371-9. doi: 10.1200/JCO.2004.00.9969.
- Results publicationThatcher N, Qian W, Girling DJ: Ifosfamide, carboplatin and etoposide with mid-cycle vincristine (ICE-V) versus standard chemotherapy (C) in patients with small cell lung cancer (SCLC) and good performance status (PS): results of an MRC randomized trial (LU21). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2489, 619, 2003.
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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.
David J. Girling, MD study chair
Medical Research Council
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 carboplatin, cisplatin and cyclophosphamide in people with Lung Cancer, run by Medical Research Council at 1 site 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 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 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002822, which also lists 2 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 19 Dec 2013.