Adenocarcinoma of the LungNCT01345851
Image-Guided Hypofractionated Radiation Therapy With Stereotactic Body Radiation Therapy Boost and Combination Chemotherapy in Treating Patients With Stage II-III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery
A study testing hypofractionated radiation therapy, laboratory biomarker analysis and image-guided radiation therapy in people with Adenocarcinoma of the Lung and Adenosquamous Cell Lung Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial studies image-guided hypofractionated radiation therapy (RT) when given together with hypofractionated RT boost and combination chemotherapy in treating patients with stage II-III non-small cell lung cancer (NSCLC) that cannot be removed by surgery. RT uses high energy x-rays to kill tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of the Lung, Adenosquamous Cell Lung Cancer, Large Cell Lung Cancer
- What is being tested?
- hypofractionated radiation therapy, laboratory biomarker analysis and image-guided radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2011to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 primary non-metastatic NSCLC; eligible histological subtypes include: squamous cell carcinoma, adenocarcinoma, squamous-adeno carcinoma, large-cell carcinoma, and non-small cell carcinoma not otherwise specified
- Clinical stage II and III NSCLC as defined by American Joint Committee on Cancer (AJCC) Cancer Staging Manual, seventh edition; acceptable imaging modalities to document nodal positivity include computed tomography (CT) chest, positron emission tomography (PET)-CT, or thoracic magnetic resonance imaging (MRI)
- For clinically stage II patients, the patient must have been evaluated by a thoracic surgeon, and deemed medically or technically inoperable, or the patient must refuse surgery
- Karnofsky performance status >= 70
- If a woman is of childbearing potential, a negative serum pregnancy test must be documented; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study treatment and for up to 4 weeks following the study treatment
Who cannot join
- Patients who have previously received therapeutic radiation therapy to the chest
- Active systemic, pulmonary, or pericardial infection
- Use of concurrent gemcitabine-based chemotherapy during radiotherapy
- Pregnant women, or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period and for up to 4 weeks after the study treatment
- Refusal to sign the informed consent
- Patients who are participating in a concurrent treatment protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: Image-Guided Hypofractionated Radiotherapy With Stereotactic Boost and Chemotherapy for Inoperable Stage II-III Non-Small Cell Lung Cancer
This clinical trial studies image-guided hypofractionated radiation therapy (RT) when given together with hypofractionated RT boost and combination chemotherapy in treating patients with stage II-III non-small cell lung cancer (NSCLC) that cannot be removed by surgery. RT uses high energy x-rays to kill tumor cells. Hypofractionated RT may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving RT together with combination chemotherapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the maximum tolerated dose (MTD) using hypofractionated RT in patients with stage II-III NSCLC.
SECONDARY OBJECTIVES:
- To determine the dose-limiting toxicity, if the MTD is reached.
II. To determine the tumor local control (LC).
III. To determine the lung cancer disease specific survival (DSS).
IV. To determine the overall survival (OS).
- To assess the transforming growth factor-beta (TGF-B), interleukin (IL)-1, and IL-6 levels as predictive biomarkers for treatment induced tissue injury.
OUTLINE: This is a dose-escalation study of image-guided hypofractionated RT.
Patients undergo image-guided hypofractionated RT over 35 minutes 5 days a week for 2 weeks followed by 5 fractions of hypofractionated RT boost. Patients also receive standard carboplatin and paclitaxel for 3 weeks.
After completion of study treatment, patients are followed up at 4-6 weeks, every 3 months for the first 2 years, and then periodically thereafter.
- Conditions
- Adenocarcinoma of the Lung, Adenosquamous Cell Lung Cancer, Large Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Squamous Cell Lung Cancer, Stage IIA Non-small Cell Lung Cancer
- Being tested
- hypofractionated radiation therapy, laboratory biomarker analysis, image-guided radiation therapy, carboplatin, paclitaxel
- Medical subject headings
- Adenocarcinoma of Lung, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypofractionated radiation therapyRadiation
Undergo image-guided hypofractionated Radiation Therapy over 35 minutes 5 days a week for 2 weeks
laboratory biomarker analysisOther
Correlative studies
image-guided radiation therapyRadiation
Undergo 5 fractions of image-guided hypofractionated Radiation Therapy boost.
carboplatinDrug
Also called Carboplat, CBDCA, JM-8, Paraplat
The maximal chemotherapy treatment dose for carboplatin during the 3 week radiation therapy is AUC 2.
paclitaxelDrug
Also called Anzatax, Asotax, TAX, Taxol
The maximal chemotherapy treatment dose for paclitaxel during the 3 week radiation therapy is 45mg/m2.
stereotactic body radiation therapyRadiation
Also called SBRT, stereotactic radiation therapy, stereotactic radiotherapy
Undergo hypofractionated RT
| Study group | Role | What they receive |
|---|---|---|
| Treatment (dose-escalation of RT) | Experimental | Patients undergo image-guided hypofractionated RT over 35 minutes 5 days a week for 2 weeks followed by 5 fractions of hypofractionated RT boost. Patients also receive standard carboplatin and paclitaxel for 3 weeks. Receives: Radiation: hypofractionated radiation therapy; Other: laboratory biomarker analysis; Radiation: image-guided radiation therapy; Drug: carboplatin; Drug: paclitaxel; Radiation: stereotactic body radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximal tolerated dose using hypofractionated radiotherapy in patients with stage II-III non small cell lung cancer.
The primary end point is to reach the maximum tolerated dose or a total of 75 Gy, whichever comes first, by escalating the daily dose of last 5 fractions.
Measured: up to 90 days
Secondary outcomes (3)
To determine tumor Local control
Radiological evaluation (CT, PET-CT) will be done to assess tumor.
Measured: participants will be followed for 2 years
To determine Lung cancer Disease specific survival
Measured: Participants will be followed for 2 years
Overall survival
Measured: Participants will be followed for 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study start23 Mar 2011
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adenocarcinoma of the LungStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Percy Lee, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345851
- Sponsor's protocol ID
- 10-001342
- Other IDs
- NCI-2011-00673
- Status last verified
- Feb 2025
- First submitted
- 27 Apr 2011
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wu TC, Luterstein E, Neilsen BK, Goldman JW, Garon EB, Lee JM, Felix C, Cao M, Tenn SE, Low DA, Kupelian PA, Steinberg ML, Lee P. Accelerated Hypofractionated Chemoradiation Followed by Stereotactic Ablative Radiotherapy Boost for Locally Advanced, Unresectable Non-Small Cell Lung Cancer: A Nonrandomized Controlled Trial. JAMA Oncol. 2024 Mar 1;10(3):352-359. doi: 10.1001/jamaoncol.2023.6033.
PubMed 38206614
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image-Guided Hypofractionated Radiotherapy With Stereotactic Boost and Chemotherapy for Inoperable Stage II-III Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01345851
- Acronym / sponsor ID
- 10-001342
- Conditions
- Adenocarcinoma of the Lung, Adenosquamous Cell Lung Cancer, Large Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Squamous Cell Lung Cancer, Stage IIA Non-small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 Mar 2011 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 2 May 2011 (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 clinical trial studies image-guided hypofractionated radiation therapy (RT) when given together with hypofractionated RT boost and combination chemotherapy in treating patients with stage II-III non-small cell lung cancer (NSCLC) that cannot be removed by surgery. RT uses high energy x-rays to kill tumor cells. Hypofractionated RT may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving RT together with combination chemotherapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started
Detailed description
PRIMARY OBJECTIVES:
- To determine the maximum tolerated dose (MTD) using hypofractionated RT in patients with stage II-III NSCLC.
SECONDARY OBJECTIVES:
- To determine the dose-limiting toxicity, if the MTD is reached.
II. To determine the tumor local control (LC).
III. To determine the lung cancer disease specific survival (DSS).
IV. To determine the overall survival (OS).
- To assess the transforming growth factor-beta (TGF-B), interleukin (IL)-1, and IL-6 levels as predictive biomarkers for treatment induced tissue injury.
OUTLINE: This is a dose-escalation study of image-guided hypofractionated RT.
Patients undergo image-guided hypofractionated RT over 35 minutes 5 days a week for 2 weeks followed by 5 fractions of hypofractionated RT boost. Patients also receive standard carboplatin and paclitaxel for 3 weeks.
After completion of study treatment, patients are followed up at 4-6 weeks, every 3 months for the first 2 years, and then periodically thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (dose-escalation of RT) | Experimental | Radiation: hypofractionated radiation therapy, Other: laboratory biomarker analysis, Radiation: image-guided radiation therapy, Drug: carboplatin, Drug: paclitaxel, Radiation: stereotactic body radiation therapyPatients undergo image-guided hypofractionated RT over 35 minutes 5 days a week for 2 weeks followed by 5 fractions of hypofractionated RT boost. Patients also receive standard carboplatin and paclitaxel for 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed primary non-metastatic NSCLC; eligible histological subtypes include: squamous cell carcinoma, adenocarcinoma, squamous-adeno carcinoma, large-cell carcinoma, and non-small cell carcinoma not otherwise specified
- Clinical stage II and III NSCLC as defined by American Joint Committee on Cancer (AJCC) Cancer Staging Manual, seventh edition; acceptable imaging modalities to document nodal positivity include computed tomography (CT) chest, positron emission tomography (PET)-CT, or thoracic magnetic resonance imaging (MRI)
- For clinically stage II patients, the patient must have been evaluated by a thoracic surgeon, and deemed medically or technically inoperable, or the patient must refuse surgery
- Karnofsky performance status >= 70
- If a woman is of childbearing potential, a negative serum pregnancy test must be documented; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study treatment and for up to 4 weeks following the study treatment
Key exclusion criteria (6 listed)
- Patients who have previously received therapeutic radiation therapy to the chest
- Active systemic, pulmonary, or pericardial infection
- Use of concurrent gemcitabine-based chemotherapy during radiotherapy
- Pregnant women, or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period and for up to 4 weeks after the study treatment
- Refusal to sign the informed consent
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 |
|---|---|---|
| hypofractionated radiation therapyUndergo image-guided hypofractionated Radiation Therapy over 35 minutes 5 days a week for 2 weeks | Radiation | Treatment (dose-escalation of RT) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (dose-escalation of RT) |
| image-guided radiation therapyUndergo 5 fractions of image-guided hypofractionated Radiation Therapy boost. | Radiation | Treatment (dose-escalation of RT) |
| carboplatinAlso: Carboplat, CBDCA, JM-8, ParaplatThe maximal chemotherapy treatment dose for carboplatin during the 3 week radiation therapy is AUC 2. | Drug | Treatment (dose-escalation of RT) |
| paclitaxelAlso: Anzatax, Asotax, TAX, TaxolThe maximal chemotherapy treatment dose for paclitaxel during the 3 week radiation therapy is 45mg/m2. | Drug | Treatment (dose-escalation of RT) |
| stereotactic body radiation therapyAlso: SBRT, stereotactic radiation therapy, stereotactic radiotherapyUndergo hypofractionated RT | Radiation | Treatment (dose-escalation of RT) |
Primary outcome
To determine the maximal tolerated dose using hypofractionated radiotherapy in patients with stage II-III non small cell lung cancer.
Time frame: up to 90 days
The primary end point is to reach the maximum tolerated dose or a total of 75 Gy, whichever comes first, by escalating the daily dose of last 5 fractions.
3 secondary outcomes
To determine tumor Local control
Time frame: participants will be followed for 2 years
To determine Lung cancer Disease specific survival
Time frame: Participants will be followed for 2 years
Overall survival
Time frame: Participants will be followed for 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Derived from this study: PubMed 38206614Wu TC, Luterstein E, Neilsen BK, Goldman JW, Garon EB, Lee JM, Felix C, Cao M, Tenn SE, Low DA, Kupelian PA, Steinberg ML, Lee P. Accelerated Hypofractionated Chemoradiation Followed by Stereotactic Ablative Radiotherapy Boost for Locally Advanced, Unresectable Non-Small Cell Lung Cancer: A Nonrandomized Controlled Trial. JAMA Oncol. 2024 Mar 1;10(3):352-359. doi: 10.1001/jamaoncol.2023.6033.
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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.
Percy Lee principal investigator
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypofractionated radiation therapy, laboratory biomarker analysis and image-guided radiation therapy in people with Adenocarcinoma of the Lung and Adenosquamous Cell Lung Cancer, run by Jonsson Comprehensive Cancer Center 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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 25 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
To determine the maximal tolerated dose using hypofractionated radiotherapy in patients with stage II-III non small cell lung cancer. (time frame: up to 90 days). 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 NCT01345851, which also lists 1 linked publication.
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 25 Feb 2026.