Lung CancerPhase 2NCT00021112
Combination Chemotherapy Plus Radiation Therapy Followed by Surgery in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer
A Phase 2 study testing cisplatin, etoposide and conventional surgery in people with Lung Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 10 sites in 4 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- cisplatin, etoposide and conventional surgery
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 10 sitesin 4 countries
- Study dates
- Apr 2001to Oct 2002
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed primary stage IIIB non-small cell lung cancer (NSCLC)
- T4, any N, M0 or any T, N3, M0
- No N3 disease due to scalene or supraclavicular lymph node involvement
- No primary tumors located in the lower lobe combined with contralateral upper higher mediastinal lymph node involvement
- No mixed tumor types with small cell lung cancer
- At least 1 unidimensionally measurable target lesion
- At least 20 mm by conventional techniques OR
- At least 10 mm by spiral CT scan
- No pre-existing pleural or pericardial effusion
- No CNS involvement by CT scan or MRI
PATIENT CHARACTERISTICS:
Age:
- 18 to 75
Performance status:
- WHO 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count at least 100,000/mm ^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST/ALT no greater than 1.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
Renal:
- Creatinine no greater than 1.25 times ULN
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No clinical evidence of superior vena cava syndrome
Pulmonary:
- Postoperative FEV1 and KCO greater than 40% predicted
- VO2 max greater than 15 mL/min/kg (if postoperative KCO no greater than 40% predicted)
Other:
- No other primary malignancy except carcinoma in situ of the cervix, adequately treated basal cell skin cancer, or other malignancy treated more than 5 years ago without recurrence (excluding melanoma, breast cancer, or hypernephroma)
- No active uncontrolled infection requiring IV antibiotics
- No pre-existing sensory neurotoxicity grade 2 or greater
- No psychological, familial, sociological, or geographical condition that would preclude study compliance
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior immunotherapy for NSCLC
- No concurrent immunotherapy during induction chemoradiotherapy
- Concurrent colony stimulating factors allowed
Chemotherapy:
- No prior chemotherapy for NSCLC
Endocrine therapy:
- No concurrent anticancer hormonal agents (except corticosteroids for antiemetic prophylaxis) during induction chemoradiotherapy
Radiotherapy:
- No prior radiotherapy for NSCLC
Surgery:
- No prior surgery for NSCLC
Other:
- No other concurrent anticancer drugs during induction chemoradiotherapy
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
Netherlands5 sites
Gelre Ziekenhuizen - Lokatie Lukas
Apeldoorn, 7334 DZ
Sint Antonius Ziekenhuis
Nieuwegein, 3435 CM
Rotterdam Cancer Institute
Rotterdam, 3000 CA
University Hospital - Rotterdam Dijkzigt
Rotterdam, 3000 CA
Academisch Ziekenhuis Utrecht
Utrecht, 3584 CX
Belgium2 sites
Algemeen Ziekenhuis Middelheim
Antwerp, 2020
Universitair Ziekenhuis Antwerpen
Edegem, B-2650
Poland2 sites
Medical University of Gdansk
Gdansk, 80-211
National Institute of Tuberculosis and Lung Diseases
Warsaw
About this study
Official title: Surgical Treatment Of Stage IIIB Non-Small Cell Lung Cancer After Induction-Chemoradiotherapy
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and radiation therapy before surgery in treating patients who have stage IIIB non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
- Determine the incidence of radically resected disease in patients with stage IIIB non-small cell lung cancer treated with induction cisplatin, etoposide, and radiotherapy followed by surgical resection.
- Determine the toxicity (morbidity and mortality) of this regimen in these patients.
- Determine the clinical response rate and pathological response rate in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive induction chemotherapy comprising cisplatin IV on day 1 and etoposide IV on days 1-3. Chemotherapy repeats every 3 weeks for 3 courses. Beginning on day 2 of the second course of chemotherapy, patients undergo induction radiotherapy once daily 5 days a week for 5-7 weeks. Chemoradiotherapy continues in the absence of disease progression or unacceptable toxicity.
At 3-6 weeks after completion of the last dose of induction radiotherapy, patients undergo lobectomy or pneumonectomy.
Patients are followed at 30 days and 4 months, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 27-62 patients will be accrued for this study.
- Conditions
- Lung Cancer
- Being tested
- cisplatin, etoposide, conventional surgery, radiation therapy
- Keywords
- 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
etoposideDrug
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 posted27 Jan 2003 (estimated)
- Study startApr 2001
- Primary completionOct 2002
Why it stopped: low accrual
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 European Organisation for Research and Treatment of Cancer - EORTCThe 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 2
- Primary purpose
- Treatment
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Rob Van Klaveren, MD, PhD, Study chair, University Medical Center Rotterdam at Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00021112
- Sponsor's protocol ID
- EORTC-08981
- Other IDs
- EORTC-08981
- Status last verified
- Jul 2012
- First submitted
- 11 Jul 2001
- Last updated
- 18 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment Of Stage IIIB Non-Small Cell Lung Cancer After Induction-Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT00021112
- Acronym / sponsor ID
- EORTC-08981
- Conditions
- Lung Cancer
- Keywords
- stage IIIB non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Apr 2001
- Primary completion
- Oct 2002 (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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and radiation therapy before surgery in treating patients who have stage IIIB non-small cell lung cancer.
Detailed description
OBJECTIVES:
- Determine the incidence of radically resected disease in patients with stage IIIB non-small cell lung cancer treated with induction cisplatin, etoposide, and radiotherapy followed by surgical resection.
- Determine the toxicity (morbidity and mortality) of this regimen in these patients.
- Determine the clinical response rate and pathological response rate in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive induction chemotherapy comprising cisplatin IV on day 1 and etoposide IV on days 1-3. Chemotherapy repeats every 3 weeks for 3 courses. Beginning on day 2 of the second course of chemotherapy, patients undergo induction radiotherapy once daily 5 days a week for 5-7 weeks. Chemoradiotherapy continues in the absence of disease progression or unacceptable toxicity.
At 3-6 weeks after completion of the last dose of induction radiotherapy, patients undergo lobectomy or pneumonectomy.
Patients are followed at 30 days and 4 months, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 27-62 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 75 years
- 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 | – |
| etoposide | Drug | – |
| conventional surgery | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2012.
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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.
Rob Van Klaveren, MD, PhD study chair
University Medical Center Rotterdam at Erasmus Medical Center
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cisplatin, etoposide and conventional surgery in people with Lung Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 10 sites in 4 countries.
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: stopped early, as of the sponsor's last update on 18 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Netherlands, Belgium, Poland, Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: low accrual). 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?
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 Jul 2012.