Lung CancerPhase 1NCT01416961
Integration of Neutron Therapy in the Treatment Plan for Stage III Non-Small Cell Lung Cancer (NSCLC)
A Phase 1 study testing Radiation Therapy, Chemotherapy - Squamous Cell Histologies and Chemotherapy - NSCLC other than squamous cell in people with Lung Cancer, run by Barbara Ann Karmanos Cancer Institute.
Trial summary
This study is needed to assess the feasibility of integrating this therapy with current treatment regimens. If this study shows success a formal phase II test study to conduct feasibility will be the next step. 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?
- Radiation Therapy, Chemotherapy - Squamous Cell Histologies and Chemotherapy - NSCLC other than squamous cell
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Dec 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IIIA :
- Histologic or cytologic diagnosis of ipsilateral mediastinal lymph node involvement, or Tumors greater than 7 cm or with chest wall invasion, or involvement of one of the following diaphragm, phrenic nerve, mediastinal pleura or parietal pericardium with hilar or mediastinal lymph node involvement.
- More than one mediastinal lymph node enlarged on CT scan and the same lymph nodes positive on PET scans or Paralyzed left vocal cord with separate lung primary distinct from the aorto-pulmonary lymph nodes on the CT scan.
- Evidence of tumor extension into the mediastinum and/or mediastinal structures either at the time of mediastinoscopy, bronchoscopy or on CT scans.
- IIIB:
- Histologic or cytologic diagnosis of N3 lymph node involvement; or Enlarged N3 lymph nodes on CT scan that are positive on PET scan as well. Patient must not have extension of lymph node involvement to cervical lymph nodes other than supraclavicular lymph nodes; or Right sided primary with left vocal cord paralysis; or Patients with a nodules in the same lung but no other areas of involvement. Patients with prior surgically resected stage I NSCLC who did not receive any adjuvant therapy, who now have stage IIIA or B NSCLC will be eligible.
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- Age ≥ 18 years
- SWOG performance status 0 or 1 (see Appendix)
- Adequate organ function as evidenced by Absolute neutrophil count of ≥ 1.5 x 10(9)/L, Platelet count ≥ 100,000 x 109/L Serum creatinine ≤ 1.5 times the institutional upper limit of normal (ULN), Calculated creatinine clearance (Cockcroft-Gault formula) of ≥ 45mL/min, Serum bilirubin ≤ ULN, Transaminases (SGOT and/or SGPT) ≤ 1.5 times institutional ULN and alkaline phosphatase ≤ 2.5 times ULN, FEV1 of ≥ 1 liter and DLCO > 50% of predicted.
- Patient should undergo brain imaging (CT scan or MRI) to rule out brain metastases.
- Signed informed consent that details the investigational nature of the study according to institutional and federal guidelines.
- Registered with Clinical Trials Office at Karmanos Cancer Institute/Wayne State University.
Who cannot join
- Prior chemotherapy, radiation for any malignancy in which they received any thoracic radiotherapy.
- Patients with concurrent malignancy. Patients with prior or concurrent malignancy will be allowed as long as the treating physician considers it unlikely to impact the clinical outcome of the patient.
- Patients with peripheral neuropathy ≥ 2.
- Serious medical illness including but not limited to uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction or cerebrovascular event with 6 months of registration, history of chronic active hepatitis or history of HIV or an active bacterial infection will not be eligible.
- Inability or unwillingness to take folic acid or Vitamin B12 or dexamethasone.
- Pregnant or lactating women. All pre-menopausal and peri-menopausal women should have a urine test for pregnancy within a week of starting therapy. All patients of child bearing potential should agree to use an effective contraceptive method.
- Patients should not participate in any other therapeutic investigational study while taking part in this study.
About this study
Official title: Phase I Study of High Linear Energy Transfer (Neutron) Therapy Followed by Concurrent Chemotherapy and Standard Photon Thoracic RT (TRT) in Stage III NSCLC (Non-Small Cell Lung Cancer) Patients
This study is needed to assess the feasibility of integrating this therapy with current treatment regimens. If this study shows success a formal phase II test study to conduct feasibility will be the next step. The first dose level chosen for this study is 66Gy of radiation to the tumor between LET and standard photon therapy. This dose is the current standard of care for stage III . If this dose is found to be feasible then the dose of LET will escalate to the total dose of 74Gy.
- Conditions
- Lung Cancer
- Being tested
- Radiation Therapy, Chemotherapy - Squamous Cell Histologies, Chemotherapy - NSCLC other than squamous cell
- Keywords
- Squamous Cell, Non-squamous cell
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
Concurrent chemo and photon radiation therapy will start within 7 days of completing neutron therapy. There will be a Day 1 of neutron therapy and a Day 1 of concurrent therapy.Photon radiation therapy will begin within 24 hours of the first cycle of chemotherapy and will be delivered 5 days per week, one fraction per day, in 1.8 Gy per fraction. High LET radiotherapy will be delivered in 1 NGy per fraction five days per week. High LET radiotherapy will be delivered first followed by combined chemoradiotherapy.
Chemotherapy - Squamous Cell HistologiesDrug
Also called Platinol ®, Platinol®-AQ, CDDP, Toposar®
Cisplatin 50 mg/m2 administered on days 1,8, 29, 36; Etoposide 50 mg/m2 administered on days 1-5 and then again days 29-33
Chemotherapy - NSCLC other than squamous cellDrug
Also called Alimta, Platinol ®, Platinol®-AQ, CDDP
Cisplatin 75 mg/m2 days 1,22,43; Pemetrexed 500 mg/m2 days 1,22,43
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess Dose levels (DLT & MTD)integrating 2 dose levels of neutron tx in 2 diff regimens of approx 12 pts/trt; If 1st dose level feasible but not 2nd dose level in either cohorts then 12 pts will be trted at 1st dose level for that particular cohort
Lab value chgs (CBC w/diff, electrolytes, serum cr., calc. cr. clearance, bilirubin, AST, ALT, ca, mg, LDH, albumin)\& for AE's-wks. 2, 5, 6, 8 \& 1 mth. after therapy. Dose Limiting Toxicities (DLT): Gr 3/4 non-hematologic tox that is trtment related; Gr 4 thrombocytopenia, Gr 3/4 neutropenic fever or gr 4 neutropenia lasting > 7 days. Assess 2 dose levels, the maximum tolerated dose (MTD) of neutron therapy-dose at which < 33% of the pts. experience DLT.
Measured: up to one month after therapy
Secondary outcomes (2)
To assess the Progression Free Survival (PFS), and response rate in these patients.
Measured: CT scan of the chest to assess the status of the cancer within 30 days of completion of therapy. If the patient has had complete or partial response, then a repeat scan no sooner than 4 weeks should be done to confirm the response.
To assess the expression of p16 expression, ERCC1 and TS expression in tumors of enrolled patients and assess the correlation of these markers with response rate and progression free survival.
Measured: Archival tissue samples collected at baseline will be assessed at baseline & 1 month after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: Neutron therapy has become unavailable
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shirish Gadgeel, Barbara Ann Karmanos Cancer Institute
- Investigators
- Shirish M. Gadgeel, M.D., Principal investigator, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416961
- Sponsor's protocol ID
- 2011-005
- Status last verified
- Aug 2012
- First submitted
- 10 Aug 2011
- Last updated
- 22 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of High Linear Energy Transfer (Neutron) Therapy Followed by Concurrent Chemotherapy and Standard Photon Thoracic RT (TRT) in Stage III NSCLC (Non-Small Cell Lung Cancer) Patients
- ClinicalTrials.gov ID
- NCT01416961
- Acronym / sponsor ID
- 2011-005
- Conditions
- Lung Cancer
- Keywords
- Squamous Cell, Non-squamous cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Neutron therapy has become unavailable
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 Aug 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 study is needed to assess the feasibility of integrating this therapy with current treatment regimens. If this study shows success a formal phase II test study to conduct feasibility will be the next step. The first dose level chosen for this study is 66Gy of radiation to the tumor between LET and standard photon therapy. This dose is the current standard of care for stage III . If this dose is found to be feasible then the dose of LET will escalate to the total dose of 74Gy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- 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 (12 listed)
- IIIA :
- Histologic or cytologic diagnosis of ipsilateral mediastinal lymph node involvement, or Tumors greater than 7 cm or with chest wall invasion, or involvement of one of the following diaphragm, phrenic nerve, mediastinal pleura or parietal pericardium with hilar or mediastinal lymph node involvement.
- More than one mediastinal lymph node enlarged on CT scan and the same lymph nodes positive on PET scans or Paralyzed left vocal cord with separate lung primary distinct from the aorto-pulmonary lymph nodes on the CT scan.
- Evidence of tumor extension into the mediastinum and/or mediastinal structures either at the time of mediastinoscopy, bronchoscopy or on CT scans.
- IIIB:
Key exclusion criteria (7 listed)
- Prior chemotherapy, radiation for any malignancy in which they received any thoracic radiotherapy.
- Patients with concurrent malignancy. Patients with prior or concurrent malignancy will be allowed as long as the treating physician considers it unlikely to impact the clinical outcome of the patient.
- Patients with peripheral neuropathy ≥ 2.
- Serious medical illness including but not limited to uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction or cerebrovascular event with 6 months of registration, history of chronic active hepatitis or history of HIV or an active bacterial infection will not be eligible.
- Inability or unwillingness to take folic acid or Vitamin B12 or dexamethasone.
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 TherapyConcurrent chemo and photon radiation therapy will start within 7 days of completing neutron therapy. There will be a Day 1 of neutron therapy and a Day 1 of concurrent therapy.Photon radiation therapy will begin within 24 hours of the first cycle of chemotherapy and will be delivered 5 days per week, one fraction per day, in 1.8 Gy per fraction. High LET radiotherapy will be delivered in 1 NGy per fraction five days per week. High LET radiotherapy will be delivered first followed by combined chemoradiotherapy. | Radiation | – |
| Chemotherapy - Squamous Cell HistologiesAlso: Platinol ®, Platinol®-AQ, CDDP, Toposar®Cisplatin 50 mg/m2 administered on days 1,8, 29, 36; Etoposide 50 mg/m2 administered on days 1-5 and then again days 29-33 | Drug | – |
| Chemotherapy - NSCLC other than squamous cellAlso: Alimta, Platinol ®, Platinol®-AQ, CDDPCisplatin 75 mg/m2 days 1,22,43; Pemetrexed 500 mg/m2 days 1,22,43 | Drug | – |
Primary outcome
Assess Dose levels (DLT & MTD)integrating 2 dose levels of neutron tx in 2 diff regimens of approx 12 pts/trt; If 1st dose level feasible but not 2nd dose level in either cohorts then 12 pts will be trted at 1st dose level for that particular cohort
Time frame: up to one month after therapy
Lab value chgs (CBC w/diff, electrolytes, serum cr., calc. cr. clearance, bilirubin, AST, ALT, ca, mg, LDH, albumin)\& for AE's-wks. 2, 5, 6, 8 \& 1 mth. after therapy. Dose Limiting Toxicities (DLT): Gr 3/4 non-hematologic tox that is trtment related; Gr 4 thrombocytopenia, Gr 3/4 neutropenic fever or gr 4 neutropenia lasting > 7 days. Assess 2 dose levels, the maximum tolerated dose (MTD) of neutron therapy-dose at which < 33% of the pts. experience DLT.
2 secondary outcomes
To assess the Progression Free Survival (PFS), and response rate in these patients.
Time frame: CT scan of the chest to assess the status of the cancer within 30 days of completion of therapy. If the patient has had complete or partial response, then a repeat scan no sooner than 4 weeks should be done to confirm the response.
To assess the expression of p16 expression, ERCC1 and TS expression in tumors of enrolled patients and assess the correlation of these markers with response rate and progression free survival.
Time frame: Archival tissue samples collected at baseline will be assessed at baseline & 1 month after therapy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2012.
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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.
Shirish M. Gadgeel, M.D. principal investigator
Barbara Ann Karmanos Cancer Institute
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Radiation Therapy, Chemotherapy - Squamous Cell Histologies and Chemotherapy - NSCLC other than squamous cell in people with Lung Cancer, run by Barbara Ann Karmanos Cancer Institute.
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 12 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: withdrawn, as of the sponsor's last update on 22 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Assess Dose levels (DLT & MTD)integrating 2 dose levels of neutron tx in 2 diff regimens of approx 12 pts/trt; If 1st dose level feasible but not 2nd dose level in either cohorts then 12 pts will be trted at 1st dose level for that particular cohort (time frame: up to one month after therapy). 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 22 Aug 2012; AzTrials last refreshed its copy on 7 Nov 2026.