Lung CancerPhase 2NCT00004253
Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery
A Phase 2 study testing carboplatin, paclitaxel and radiation therapy in people with Lung Cancer, run by Baptist Health South Florida at 2 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Specialized radiation therapy delivers a high dose of radiation directly to the tumor which may kill more tumor cells and cause less damage to normal tissue. 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?
- carboplatin, paclitaxel and radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Mar 2000to not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Patients with unresected locally advanced non-small cell lung cancer
- Stage II, IIIA, or IIIB
- No evidence of hematogenous metastases
- No pleural effusion(s) on chest x-ray (except after a thoracotomy or other invasive thoracic procedure)
- No intrathoracic tumor recurrence following resection
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 70-100%
Life expectancy:
- Not specified
Hematopoietic:
- Absolute granulocyte count at least 2,000/mm3
- Platelet count at least 130,000/mm3
- Hemoglobin at least 10 g/dL
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- SGOT no greater than 1.5 times upper limit of normal (unless caused by documented benign disease)
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
- No active or symptomatic cardiac disease
- No acute myocardial infarction within the past 6 months
- No angina
- No congestive heart failure
- No uncontrolled arrhythmias
- Cardiac ejection fraction greater than 50%
Pulmonary:
- FEV1 at least 1.25 L AND
- DLCO at least 50% predicted
Other:
- Not pregnant
- Fertile patients must use effective contraception
- Weight loss no greater than 5% within 3 months of diagnosis
- No other prior malignancy within the past 3 years except nonmelanomatous skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior thoracic or neck radiotherapy
Surgery:
- See Disease Characteristics
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
Baptist Hospital of Miami
Miami, Florida, 33176-2197
About this study
Official title: A Phase II Study of 3-Dimensional Conformal Hyperfractionation Radiation Therapy (3D-CHRT) With Dose Escalation and Amifostine Mucosal Protection for Patients With Favorable Prognosis Inoperable Stage II-IIIA/B Non-Small Cell Lung Cancer (NSCLC) Receiving Paclitaxel and Carboplatin
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Specialized radiation therapy delivers a high dose of radiation directly to the tumor which may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and specialized high-dose radiation therapy in treating patients who have stage II or stage III non-small cell lung cancer that cannot be removed by surgery.
Read the detailed description
OBJECTIVES:
- Determine the probability of overall survival and local control in patients with favorable prognosis, unresectable stage II-IIIA/B non-small cell lung cancer receiving paclitaxel and carboplatin plus 3-D conformal hyperfractionation radiotherapy (3D-CHRT).
- Determine the incidence and severity of nonhematologic toxicity, specifically esophagitis and pneumonitis, during 3D-CHRT and chemotherapy with paclitaxel and carboplatin in these patients.
- Correlate complication rate with radiation based on the effective dose to determine safe treatment guidelines.
- Determine the feasibility of patient-specific dose escalation using this regimen in these patients.
- Determine the quality of life and symptom distress in these patients on this regimen.
OUTLINE: This is a dose-escalation study of 3-D conformal hyperfractionated radiotherapy (3D-CHRT).
Patients receive paclitaxel IV over 1 hour followed immediately by carboplatin IV over 30 minutes weekly for 6-8 weeks. Patients undergo 3D-CHRT twice daily five days a week for 6-8 weeks.
Cohorts of patients receive escalating doses of 3D-CHRT in 4 dose levels.
Quality of life is assessed prior to study, weekly during chemotherapy and radiotherapy, and at 3 and 6 months.
Patients are followed at 6 weeks, every 3 months for 1 year, every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 26-72 patients will be accrued for this study within 3 years.
- Conditions
- Lung Cancer
- Being tested
- carboplatin, paclitaxel, radiation therapy
- Keywords
- 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.
carboplatinDrug
paclitaxelDrug
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2003 (estimated)
- Study startMar 2000
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
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Baptist Health South Florida
- Sponsor type
- University, hospital or other
- Investigators
- Andre A. Abitbol, MD, Study chair, Baptist Health South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004253
- Sponsor's protocol ID
- CDR0000067500
- Other IDs
- BHM-L1, BHM-99-64, NCI-V99-1582
- Status last verified
- Nov 2002
- First submitted
- 28 Jan 2000
- Last updated
- 18 Dec 2013
- Results posted
- No
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 Phase II Study of 3-Dimensional Conformal Hyperfractionation Radiation Therapy (3D-CHRT) With Dose Escalation and Amifostine Mucosal Protection for Patients With Favorable Prognosis Inoperable Stage II-IIIA/B Non-Small Cell Lung Cancer (NSCLC) Receiving Paclitaxel and Carboplatin
- ClinicalTrials.gov ID
- NCT00004253
- Acronym / sponsor ID
- CDR0000067500
- Conditions
- Lung Cancer
- Keywords
- stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Baptist Health South FloridaUniversity, hospital or other
- Study start
- Mar 2000
- First posted
- 23 Jul 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. Specialized radiation therapy delivers a high dose of radiation directly to the tumor which may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and specialized high-dose radiation therapy in treating patients who have stage II or stage III non-small cell lung cancer that cannot be removed by surgery.
Detailed description
OBJECTIVES:
- Determine the probability of overall survival and local control in patients with favorable prognosis, unresectable stage II-IIIA/B non-small cell lung cancer receiving paclitaxel and carboplatin plus 3-D conformal hyperfractionation radiotherapy (3D-CHRT).
- Determine the incidence and severity of nonhematologic toxicity, specifically esophagitis and pneumonitis, during 3D-CHRT and chemotherapy with paclitaxel and carboplatin in these patients.
- Correlate complication rate with radiation based on the effective dose to determine safe treatment guidelines.
- Determine the feasibility of patient-specific dose escalation using this regimen in these patients.
- Determine the quality of life and symptom distress in these patients on this regimen.
OUTLINE: This is a dose-escalation study of 3-D conformal hyperfractionated radiotherapy (3D-CHRT).
Patients receive paclitaxel IV over 1 hour followed immediately by carboplatin IV over 30 minutes weekly for 6-8 weeks. Patients undergo 3D-CHRT twice daily five days a week for 6-8 weeks.
Cohorts of patients receive escalating doses of 3D-CHRT in 4 dose levels.
Quality of life is assessed prior to study, weekly during chemotherapy and radiotherapy, and at 3 and 6 months.
Patients are followed at 6 weeks, every 3 months for 1 year, every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 26-72 patients will be accrued for this study within 3 years.
Study design
- Primary purpose
- Treatment
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 |
|---|---|---|
| carboplatin | Drug | – |
| paclitaxel | Drug | – |
| 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.
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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.
Andre A. Abitbol, MD study chair
Baptist Health South Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing carboplatin, paclitaxel and radiation therapy in people with Lung Cancer, run by Baptist Health South Florida at 2 sites in United States.
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 2 sites in United States. 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?
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 Dec 2013.