Carcinoma, Non-Small-Cell LungNCT00256789
Once Weekly Radiation for Lung Cancer With Chemotherapy
A study testing Radiation and Chemotherapy in people with Carcinoma, Non-Small-Cell Lung, run by Clinical Oncology Research Associates at 1 site in United States.
Trial summary
This program is designed for the treatment of patients with advanced non-small cell lung cancer. The study is designed for patients whose cancer is too advanced and therefore cannot be operated with the goal of completely removing the cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Radiation and Chemotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Dec 2004
- Phase
- Interventional
- 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
Who may be able to join
- Patients must have histologic evidence of NSCLC.
- Should the patient have a history of another malignancy or a second malignancy be present or discovered, subjects will only be eligible if the NSCLC is determined by the PI to be the more life-threatening disease and the other malignancy would not have otherwise a significant impact on the subjects life-expectancy (e.g. basal cell carcinoma of skin, remote history of early stage breast cancer surgically cured).
- All patients must have surgically incurable disease, i.e. locally advanced disease (stage III A or III B) or metastatic stage IV.
- Performance status of 0 to 2 (ECOG Criteria).
- Patients should have an absolute granulocyte count > 1500/mm3 and a platelet count > 100,000/mm3.
- Patients should have adequate hepatic function as indicated by a serum bilirubin < upper limit of normal (ULN); ALT and AST <2.5 ULN if alkaline phosphatase is < ULN. 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.
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- Patients should have at least a predicted FEV1 of 30%.
- Patients with active ischemic heart disease (NYHA Class III or IV), congestive heart failure, symptomatic arrythmias, or a recent history of a myocardial infarction are excluded.
- Patients with pre-existing neuropathy (> grade 1) are not eligible for this study.
- No other serious concurrent medical illness or active infection which would jeopardize the ability of the patient to receive with reasonable safety the chemotherapy and surgery program outlined in this protocol is allowed.
- Signed informed consent: each patient must be aware of the neoplastic nature of his/her disease and willingly consent to participate in the study after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts.
- Pregnant women and nursing mothers are ineligible. Women of child-bearing potential must have a negative pregnancy test. Women of childbearing potential must be willing to consent to using effective contraception while on treatment and for three months thereafter.
- Patients with a history of severe hypersensitivity reaction to TaxotereÒ or other drugs formulated with polysorbate 80 must be excluded.
- Patients must be at least 18 years old.
- -
Who cannot join
- Not falling into the eligibility criteria outlined above
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Center and Mobile Infirmary Hospital
Mobile, Alabama, 36607
About this study
Official title: Combination of Weekly Radiation and Docetaxel for Locally Advanced Non Small Cell Lung Cancer: A Feasibility Study
This program is designed for the treatment of patients with advanced non-small cell lung cancer. The study is designed for patients whose cancer is too advanced and therefore cannot be operated with the goal of completely removing the cancer. Patients at this stage of their disease traditionally receive radiation therapy or chemotherapy or both treatments in succession. Recently, the administration of both methods of treatment has been employed and preliminary studies indicate somewhat better results. Specifically, a new class of chemotherapy agents called taxanes used in combination with radiation therapy appear promising as determined in small studies. However, the best treatment for this type of cancer has not been established yet. One goal of this study is to investigate if the combination of the new drug Taxotere (a drug belonging to the taxane class) given on the day of the radiation is well tolerated and will result in enhanced shrinkage of the cancer compared to traditional radiation therapy. In this study the radiation will be given on one day, rather than divided over five days per week (Monday through Friday) as in previous studies. Previous research has shown that both equal in how effective they are in treating lung cancer. The study will use the drug Taxotere in conjunction with radiation therapy. Taxotere is an approved medicine by the United States Food and Drug Administration for the treatment of lung cancer.
The purpose of this study is to evaluate if the chemotherapy drug Taxotere administered once weekly together with concurrent radiation on the same day is effective in shrinking non-small cell lung cancer. This trial will also investigate how well this treatment is tolerated and what effects this treatment will have on the everyday life and activities of participants.
Read the detailed description
40 patients with locally advanced and metastatic NSCLC will be enrolled (stages III and IV) and treated once per week for a total of 12 cycles (12 weeks) according to the schedule outlined below.
Chemotherapy: The suggested phase II dose for weekly Taxotere with concomitant standard chest radiotherapy was determined to be 20mg/m2. In our unpublished phase I clinical trial, we found 35 mg/m2 to be well tolerated and therefore this dose is chosen for this phase II study. The drug will be administered intravenously on the same day as the radiation. All patients will be premedicated 12 hours prior to chemotherapy with Decadrone. Patients will be followed and evaluated weekly by a physician.
Radiation therapy: Although radiation was delivered differently in previous Taxotere based combined modality studies, the total radiation dose remains the same. Treatment will be given to a large field with a 2-3 cm tumor margin. All involved or suspicious nodal areas will be radiated as well. To reduce volume toxicity, the "field within a field" technique will be employed. Tumor and involved nodes will receive 200 cGy + 300 cGy. A total of 12 treatments will be administered in weekly, single sessions. Total treatment will be 6000 cGy. Radiation treatment will be administered 24 hours after Taxotere infusion.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Radiation, Chemotherapy
- Keywords
- NSCLC, Non-Small Cell Lung Cancer,Weekly Radiation, Taxotere
- 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.
RadiationProcedure or surgery
ChemotherapyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Secondary outcomes (1)
Toxicity, Safety, Efficacy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2005 (estimated)
- Study startSep 2002
- Primary completionDec 2003
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Oncology Research Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Aventis Pharmaceuticals
- Investigators
- Paul Schwarzenberger, MD, Principal investigator, Mobile Infirmary Hospital, Mobile, AL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256789
- Sponsor's protocol ID
- Hypo 1
- Status last verified
- Nov 2005
- First submitted
- 18 Nov 2005
- Last updated
- 11 Feb 2014
- Results posted
- No
Publications
Slawson RG, Salazar OM, Poussin-Rosillo H, Amin PP, Strohl R, Sewchand W. Once-a-week vs conventional daily radiation treatment for lung cancer: final report. Int J Radiat Oncol Biol Phys. 1988 Jul;15(1):61-8. doi: 10.1016/0360-3016(88)90347-1.
PubMed 2839442Salazar OM, Slawson RG, Poussin-Rosillo H, Amin PP, Sewchand W, Strohl RA. A prospective randomized trial comparing once-a-week vs daily radiation therapy for locally-advanced, non-metastatic, lung cancer: a preliminary report. Int J Radiat Oncol Biol Phys. 1986 May;12(5):779-87. doi: 10.1016/0360-3016(86)90036-2.
PubMed 3519551Salazar OM, Van Houtte P, Rubin P. Once-a-week radiation therapy for locally advanced lung cancer. Final report. Cancer. 1984 Aug 15;54(4):719-25. doi: 10.1002/1097-0142(1984)54:43.0.co;2-s.
PubMed 6744205
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Weekly Radiation and Docetaxel for Locally Advanced Non Small Cell Lung Cancer: A Feasibility Study
- ClinicalTrials.gov ID
- NCT00256789
- Acronym / sponsor ID
- Hypo 1
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- NSCLC, Non-Small Cell Lung Cancer,Weekly Radiation, Taxotere
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Clinical Oncology Research AssociatesUniversity, hospital or other
- Collaborators
- Aventis Pharmaceuticals
- Study start
- Sep 2002
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 22 Nov 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.
This program is designed for the treatment of patients with advanced non-small cell lung cancer. The study is designed for patients whose cancer is too advanced and therefore cannot be operated with the goal of completely removing the cancer. Patients at this stage of their disease traditionally receive radiation therapy or chemotherapy or both treatments in succession. Recently, the administration of both methods of treatment has been employed and preliminary studies indicate somewhat better results. Specifically, a new class of chemotherapy agents called taxanes used in combination with radiation therapy appear promising as determined in small studies. However, the best treatment for this type of cancer has not been established yet. One goal of this study is to investigate if the combination of the new drug Taxotere (a drug belonging to the taxane class) given on the day of the radiation is well tolerated and will result in enhanced shrinkage of the cancer compared to traditional radiation therapy. In this study the radiation will be given on one day, rather than divided over five days per week (Monday through Friday) as in previous studies. Previous research has shown that both equal in how effective they are in treating lung cancer. The study will use the drug Taxotere in conjunction with radiation therapy. Taxotere is an approved medicine by the United States Food and Drug Administration for the treatment of lung cancer.
The purpose of this study is to evaluate if the chemotherapy drug Taxotere administered once weekly together with concurrent radiation on the same day is effective in shrinking non-small cell lung cancer. This trial will also investigate how well this treatment is tolerated and what effects this treatment will have on the everyday life and activities of participants.
Detailed description
40 patients with locally advanced and metastatic NSCLC will be enrolled (stages III and IV) and treated once per week for a total of 12 cycles (12 weeks) according to the schedule outlined below.
Chemotherapy: The suggested phase II dose for weekly Taxotere with concomitant standard chest radiotherapy was determined to be 20mg/m2. In our unpublished phase I clinical trial, we found 35 mg/m2 to be well tolerated and therefore this dose is chosen for this phase II study. The drug will be administered intravenously on the same day as the radiation. All patients will be premedicated 12 hours prior to chemotherapy with Decadrone. Patients will be followed and evaluated weekly by a physician.
Radiation therapy: Although radiation was delivered differently in previous Taxotere based combined modality studies, the total radiation dose remains the same. Treatment will be given to a large field with a 2-3 cm tumor margin. All involved or suspicious nodal areas will be radiated as well. To reduce volume toxicity, the "field within a field" technique will be employed. Tumor and involved nodes will receive 200 cGy + 300 cGy. A total of 12 treatments will be administered in weekly, single sessions. Total treatment will be 6000 cGy. Radiation treatment will be administered 24 hours after Taxotere infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must have histologic evidence of NSCLC.
- Should the patient have a history of another malignancy or a second malignancy be present or discovered, subjects will only be eligible if the NSCLC is determined by the PI to be the more life-threatening disease and the other malignancy would not have otherwise a significant impact on the subjects life-expectancy (e.g. basal cell carcinoma of skin, remote history of early stage breast cancer surgically cured).
- All patients must have surgically incurable disease, i.e. locally advanced disease (stage III A or III B) or metastatic stage IV.
- Performance status of 0 to 2 (ECOG Criteria).
- Patients should have an absolute granulocyte count > 1500/mm3 and a platelet count > 100,000/mm3.
Key exclusion criteria (1 listed)
- Not falling into the eligibility criteria outlined above
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 |
|---|---|---|
| Radiation | Procedure or surgery | – |
| Chemotherapy | Drug | – |
Primary outcome
Feasibility
1 secondary outcome
Toxicity, Safety, Efficacy
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 11 Feb 2014.
- Background: PubMed 2839442Slawson RG, Salazar OM, Poussin-Rosillo H, Amin PP, Strohl R, Sewchand W. Once-a-week vs conventional daily radiation treatment for lung cancer: final report. Int J Radiat Oncol Biol Phys. 1988 Jul;15(1):61-8. doi: 10.1016/0360-3016(88)90347-1.
- Background: PubMed 3519551Salazar OM, Slawson RG, Poussin-Rosillo H, Amin PP, Sewchand W, Strohl RA. A prospective randomized trial comparing once-a-week vs daily radiation therapy for locally-advanced, non-metastatic, lung cancer: a preliminary report. Int J Radiat Oncol Biol Phys. 1986 May;12(5):779-87. doi: 10.1016/0360-3016(86)90036-2.
- Background: PubMed 6744205Salazar OM, Van Houtte P, Rubin P. Once-a-week radiation therapy for locally advanced lung cancer. Final report. Cancer. 1984 Aug 15;54(4):719-25. doi: 10.1002/1097-0142(1984)54:43.0.co;2-s.
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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.
Paul Schwarzenberger, MD principal investigator
Mobile Infirmary Hospital, Mobile, AL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation and Chemotherapy in people with Carcinoma, Non-Small-Cell Lung, run by Clinical Oncology Research Associates 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 15 inclusion and 1 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 11 Feb 2014. 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.
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.
What does the primary outcome measure?
Feasibility. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00256789, which also lists 3 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 11 Feb 2014.