Non-small Cell Lung CancerPhase 1NCT00692380
Gated Intensity Modulated Radiation Therapy and Concurrent Chemotherapy for Inoperable NSCLC
A Phase 1 study testing Fractionated radiation therapy followed by chemotherapy in people with Non-small Cell Lung Cancer, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
Radiation therapy technology that allows increased radiation dose to the tumor while sparing healthy tissue will improve the balance between complications and cure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Fractionated radiation therapy followed by chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Jun 2010
- Phase
- Phase 1
- 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 with histologically-proven, by biopsy or cytology, unresectable lung cancer of the following histologic types: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, non-small cell carcinoma, not otherwise specified.
- Patient with AJCC Stage IIIA-IIIB, if all detectable tumor can be encompassed by radiation therapy fields, including both the primary tumor and the involved regional lymph nodes.
- 18-fluoro-2-deoxyglucose positron emission tomography required for staging and image fusion for treatment planning.
- Atelectasis, if present, must be less than one lung.
- Patients must have granulocytes >1500/µl; platelets >100,000/µl; bilirubin < 1.5 mg/dl; AST(SGOT) < 2 ULN; serum creatinine < 2.0 mg/dl.
- Zubrod Score 0-1.
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- FEV1 must be >1.0 L.
- Patients must sign a study-specific informed consent form prior to study entry
- Patients must have measurable disease on the planning CT.
- Patient must have a completed the IMRT plan and the attending physician must have reviewed and approved the dose volume histograms as follows (based on treatment planning to the Phase 4 dose level): total lung V20 < 30%, mean esophageal dose < 34 Gy, the esophageal V55 < 30%, the heart V40 < 50%.
- No prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for one year or more; no prior lung cancer within last two years.
- No prior RT to thorax.
- No previous chemotherapy or previous biologic response modifiers for current lung cancer or within the past five (5) years.
- No distant metastases or supraclavicular lymph node involvement or significant atelectasis.
- No clinically significant pleural effusions, pericardial effusions or superior vena cava syndrome.
Who cannot join
- Undifferentiated small cell (oat cell or high grade neuroendocrine) carcinoma, any stage.
- Stage I, II or IV NSCLC.
- Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery.
- Concurrent malignancy except non-melanomatous skin cancer or prior cancer unless disease-free for one year or more.
- Prior radiation therapy to the thorax.
- Previous chemotherapy or previous biologic response modifiers for current lung cancer or within the past five (5) years.
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- Distant metastases or supraclavicular lymph node involvement, or atelectasis of an entire lung.
- Patients who have not had the pre-treatment evaluations in Section 4.0 or evaluations performed > 8 weeks prior to study entry.
- Patients with clinically significant pleural effusions, pericardial effusions or superior vena cava syndrome.
- Prior lung cancer within the last two years.
- Patients who have significant atelectasis and in whom the CT definition of the gross tumor volume(GTV) is difficult to determine.
- Pregnant or lactating females. It is not known what effects this treatment may have on the developing fetus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Dose Intensification Study Using Gated Intensity Modulated Radiation Therapy and Concurrent Chemotherapy for Patients With Inoperable, Non-Small Cell Lung Cancer
Radiation therapy technology that allows increased radiation dose to the tumor while sparing healthy tissue will improve the balance between complications and cure.
Read the detailed description
The primary objective is to establish the maximum tolerated fractional dose (MTfD) of radiotherapy to a total dose of 78Gy using gated IMRT, delivered in single daily fractions that can be administered concurrently with Taxol® and carboplatin chemotherapy. Secondary objectives include: to evaluate the toxicity of concurrent Taxol® and carboplatin with gated IMRT; identify partial organ tolerance doses for lung and esophagus when treating with involved field thoracic 3D; estimate complete response rate as defined by PET performed 3 months after completion of all therapy.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Fractionated radiation therapy followed by chemotherapy
- Keywords
- gated IMRT
- 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.
Fractionated radiation therapy followed by chemotherapyRadiation
Increasing doses of radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Fractionated Radiation Therapy followed by Carboplatin and Taxol Receives: Radiation: Fractionated radiation therapy followed by chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Measured: 3 years
Secondary outcomes (1)
To identify partial organ tolerance doses for lung and esophagus when treating with involved field thoracic 3D. To estimate complete response rate as defined by PET performed 3 months after completion of all therapy.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startJun 2006
- Primary completionApr 2010
- Study completionJun 2010
Why it stopped: insufficient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth Weiss, M.D., Principal investigator, Massey Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692380
- Sponsor's protocol ID
- MCC-10274
- Status last verified
- Apr 2016
- First submitted
- 3 Jun 2008
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Intensification Study Using Gated Intensity Modulated Radiation Therapy and Concurrent Chemotherapy for Patients With Inoperable, Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00692380
- Acronym / sponsor ID
- MCC-10274
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- gated IMRT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient accrual
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 6 Jun 2008 (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.
Radiation therapy technology that allows increased radiation dose to the tumor while sparing healthy tissue will improve the balance between complications and cure.
Detailed description
The primary objective is to establish the maximum tolerated fractional dose (MTfD) of radiotherapy to a total dose of 78Gy using gated IMRT, delivered in single daily fractions that can be administered concurrently with Taxol® and carboplatin chemotherapy. Secondary objectives include: to evaluate the toxicity of concurrent Taxol® and carboplatin with gated IMRT; identify partial organ tolerance doses for lung and esophagus when treating with involved field thoracic 3D; estimate complete response rate as defined by PET performed 3 months after completion of all therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Radiation: Fractionated radiation therapy followed by chemotherapyFractionated Radiation Therapy followed by Carboplatin and Taxol |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Patients with histologically-proven, by biopsy or cytology, unresectable lung cancer of the following histologic types: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, non-small cell carcinoma, not otherwise specified.
- Patient with AJCC Stage IIIA-IIIB, if all detectable tumor can be encompassed by radiation therapy fields, including both the primary tumor and the involved regional lymph nodes.
- 18-fluoro-2-deoxyglucose positron emission tomography required for staging and image fusion for treatment planning.
- Atelectasis, if present, must be less than one lung.
- Patients must have granulocytes >1500/µl; platelets >100,000/µl; bilirubin < 1.5 mg/dl; AST(SGOT) < 2 ULN; serum creatinine < 2.0 mg/dl.
Key exclusion criteria (12 listed)
- Undifferentiated small cell (oat cell or high grade neuroendocrine) carcinoma, any stage.
- Stage I, II or IV NSCLC.
- Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery.
- Concurrent malignancy except non-melanomatous skin cancer or prior cancer unless disease-free for one year or more.
- Prior radiation therapy to the thorax.
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 |
|---|---|---|
| Fractionated radiation therapy followed by chemotherapyIncreasing doses of radiation therapy | Radiation | A |
Primary outcome
Maximum tolerated dose
Time frame: 3 years
1 secondary outcome
To identify partial organ tolerance doses for lung and esophagus when treating with involved field thoracic 3D. To estimate complete response rate as defined by PET performed 3 months after completion of all therapy.
Time frame: 3 years
Results and safety
The study was stopped early (reason given: insufficient accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2016.
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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.
Elisabeth Weiss, M.D. principal investigator
Massey Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fractionated radiation therapy followed by chemotherapy in people with Non-small Cell Lung Cancer, run by Virginia Commonwealth University 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 12 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: stopped early, as of the sponsor's last update on 2 May 2016. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: insufficient 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.
What does the primary outcome measure?
Maximum tolerated dose (time frame: 3 years). It is what the study was designed to measure, not a finding.
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 2 May 2016.