Carcinoma, Non-Small-Cell LungPhase 2NCT00167401
Trial of Chemotherapy Followed by Pulsed Docetaxel and Concurrent Radiation for Non-Small Cell Lung Cancer
A Phase 2 study testing docetaxel, cisplatin and radiation treatment in people with Carcinoma, Non-Small-Cell Lung, run by University of Rochester at 1 site in United States.
Trial summary
The University of Rochester Cancer Center (URCC) is conducting a research study at Highland Hospital and Strong Memorial of lung cancer patients whose tumors cannot be surgically removed. The usual treatment for this stage of cancer is chemotherapy (treatment with drugs) combined with radiation (chemo-radiation). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- docetaxel, cisplatin and radiation treatment
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Feb 2002to Jun 2007
- 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
Who may be able to join
- Histologically confirmed non-small cell lung cancer.
- Clinical or pathologic stage IIIA (T1-3N2M0, T3N1M0) and IIIB (Any T N3M0, T4 Any N M0) diseases according to the American Joint Committee of Cancer criteria (Appendix I). Patients with malignant pleural effusion will be excluded.
- The primary tumor must be radiographically measurable with bi-dimensionally measurable disease
- Age > 18.
- Karnofsky performance status > 70 (Appendix II).
- FEV1 sufficient for patients to tolerate radiation therapy, which is at the discretion of the radiation oncologist, usually > 800 ml, but may be higher or lower depending on the volume of radiotherapy portal, which is a variable of the tumor extent.
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- WBC > 3000; platelet count > 100,000; absolute neutrophil counts > 1,000; hemoglobin ≥ 8.0 g/dl; serum creatinine < 1.5 mg/dl or creatinine clearance >60 ml/min. Laboratory values must be obtained < 3 weeks prior to registration.
- Patients with equivocal enlargement of adrenal gland(s) on CT scan, or a few equivocal regional or distant lesions on any imaging studies need further imaging study or biopsy to rule out distant metastasis.
- Transaminases (SGOT and/or SGPT) may be up to 2.5 x institutional upper limit of normal (ULN) if alkaline phosphatase is < ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are < ULN. However, patients who have both transaminase elevation > 1.5 x ULN and alkaline phosphatase > 2.5 x ULN are not eligible for this study (due to decreased clearance of docetaxel and increased risk of toxicity).
- Pre-existing neuropathy must be grade I or less.
- A signed informed consent.
- Women of childbearing potential must have a negative pregnancy test.
- Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter.
Who cannot join
- Patients with distant metastasis (stage IV disease).
- Patients without measurable disease.
- Patients with medical contraindication to chemotherapy or radiotherapy.
- Patients with myocardial infarction within the preceding six months or symptomatic heart disease, including angina, congestive heart failure, uncontrolled arrhythmia.
- Patients with bilirubin elevated above institutional upper limit of normal (ULN) must be excluded.
- Women who are pregnant or breast feeding are not eligible.
- Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80 must be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester, Dept. Radiation Oncology
Rochester, New York, 14642
About this study
Official title: A Phase II Trial of One-Cycle Induction Chemotherapy Followed by Pulsed Docetaxel and Concurrent Radiation for Non-Small Cell Lung Cancer
The University of Rochester Cancer Center (URCC) is conducting a research study at Highland Hospital and Strong Memorial of lung cancer patients whose tumors cannot be surgically removed. The usual treatment for this stage of cancer is chemotherapy (treatment with drugs) combined with radiation (chemo-radiation). Because of the risk of spread to other organs, patients with your stage of disease are also often treated with additional chemotherapy, either before or after the chemo-radiation treatment. The best timing and number of treatments for this additional chemotherapy has not been clearly established. The purpose of this study is to help determine if a single treatment with two chemotherapy drugs, followed by radiation and low-dose chemotherapy is an effective way to treat patients with lung cancer. The side effects of this treatment and your quality of life while on the study will also be studied. Eighteen will participate in this study locally.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startFeb 2002
- Primary completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Investigators
- Yuhchyau Chen, MD, Ph.D, Principal investigator, Universtiy of Rochester, Dept of Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167401
- Sponsor's protocol ID
- URCC 1500
- Other IDs
- Aventis 12083-Chen
- Status last verified
- May 2009
- First submitted
- 9 Sep 2005
- Last updated
- 19 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of One-Cycle Induction Chemotherapy Followed by Pulsed Docetaxel and Concurrent Radiation for Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00167401
- Acronym / sponsor ID
- URCC 1500
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Feb 2002
- Primary completion
- Jun 2007 (actual)
- First posted
- 14 Sep 2005 (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.
The University of Rochester Cancer Center (URCC) is conducting a research study at Highland Hospital and Strong Memorial of lung cancer patients whose tumors cannot be surgically removed. The usual treatment for this stage of cancer is chemotherapy (treatment with drugs) combined with radiation (chemo-radiation). Because of the risk of spread to other organs, patients with your stage of disease are also often treated with additional chemotherapy, either before or after the chemo-radiation treatment. The best timing and number of treatments for this additional chemotherapy has not been clearly established. The purpose of this study is to help determine if a single treatment with two chemotherapy drugs, followed by radiation and low-dose chemotherapy is an effective way to treat patients with lung cancer. The side effects of this treatment and your quality of life while on the study will also be studied. Eighteen will participate in this study locally.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically confirmed non-small cell lung cancer.
- Clinical or pathologic stage IIIA (T1-3N2M0, T3N1M0) and IIIB (Any T N3M0, T4 Any N M0) diseases according to the American Joint Committee of Cancer criteria (Appendix I). Patients with malignant pleural effusion will be excluded.
- The primary tumor must be radiographically measurable with bi-dimensionally measurable disease
- Age > 18.
- Karnofsky performance status > 70 (Appendix II).
Key exclusion criteria (7 listed)
- Patients with distant metastasis (stage IV disease).
- Patients without measurable disease.
- Patients with medical contraindication to chemotherapy or radiotherapy.
- Patients with myocardial infarction within the preceding six months or symptomatic heart disease, including angina, congestive heart failure, uncontrolled arrhythmia.
- Patients with bilirubin elevated above institutional upper limit of normal (ULN) must be excluded.
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 |
|---|---|---|
| docetaxel | Drug | – |
| cisplatin | Drug | – |
| radiation treatment | Procedure or surgery | – |
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 May 2009.
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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.
Yuhchyau Chen, MD, Ph.D principal investigator
Universtiy of Rochester, Dept of Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing docetaxel, cisplatin and radiation treatment in people with Carcinoma, Non-Small-Cell Lung, run by University of Rochester at 1 site 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?
The sponsor lists 13 inclusion and 7 exclusion criteria. 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: finished, as of the sponsor's last update on 19 May 2009. 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 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?
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?
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 May 2009.