Non-small Cell Lung CarcinomaNCT02394548
Phase I Trial Of IMRT Using A Contralateral Esophagus Sparing Technique (CEST) In Locally Advanced Lung Cancer
A study testing Contralateral Esophageal Sparing Technique (CEST) in people with Non-small Cell Lung Carcinoma and Small Cell Lung Carcinoma, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
This research study is examining the benefit of a novel radiation planning approach on the likelihood of developing severe esophagitis (irritation and inflammation of the esophagus) during the course of radiation therapy with concurrent chemotherapy which is associated with very painful and difficult swallowing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Carcinoma, Small Cell Lung Carcinoma
- What is being tested?
- Contralateral Esophageal Sparing Technique (CEST)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2015to Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participants must meet the following criteria on screening examination to be eligible to participate in the study.
- Histologically or cytologically proven diagnosis of NSCLC or SCLC
- NSCLC, patients with clinical stage IIB-IV patients (AJCC, 7th ed.) are eligible, and for SCLC, limited-stage patients are eligible, if documented to be a candidate for definitive radiation and concurrent chemotherapy in the radiation oncologist or medical oncologist clinic note.
- Stage IV NSCLC patients are eligible only if they have a solitary brain metastasis
- Patients with non-malignant pleural effusion are eligible. --- If a pleural effusion is present, the following criteria must be met to exclude malignant involvement:
- When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative.
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- Exudative pleural effusions are excluded, regardless of cytology;
- Effusions that are minimal (ie, not visible on chest x-ray) that are too small to safely tap are eligible.
- Gross tumor (primary tumor or involved lymph node) must be within 1 cm of esophagus on the most recent chest CT scan.
- ECOG performance status 0-1 within 30 days prior to registration;
- Age ≥18
- Women of childbearing potential must indicate that there is not a possibility of being pregnant at the time of enrollment or have a negative serum pregnancy test prior to the initiation of radiation therapy.
- Women of childbearing potential and male participants must practice adequate contraception.
- Patient must provide study-specific informed consent prior to study entry.
Who cannot join
- Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
- Greater than minimal, exudative, or cytologically positive pleural effusions
- Tumor suspected or known to invade the esophagus
- Prior chemotherapy if this precludes administration of concurrent chemotherapy for protocol treatment. Note that induction chemotherapy is allowed as long as concurrent chemotherapy is possible.
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
- Any history of allergic reaction to chemotherapies used
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02115
Newton-Wellesley Hospital
Newton, Massachusetts, 02462
About this study
Official title: A Phase I Trial Of Intensity-Modulated Radiation Therapy (IMRT) Using A Contralateral Esophagus Sparing Technique (CEST) In Locally Advanced Non-Small Cell Lung Cancer (NSCLC) And Limited-Stage Small Cell Lung Cancer (LS-SCLC).
This research study is examining the benefit of a novel radiation planning approach on the likelihood of developing severe esophagitis (irritation and inflammation of the esophagus) during the course of radiation therapy with concurrent chemotherapy which is associated with very painful and difficult swallowing.
Read the detailed description
This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied.
The U.S. Food and Drug Administration (FDA) has approved radiation with chemotherapy as a treatment option for your disease.
Currently, there are no established rules to avoid esophagitis in the treatment of lung cancer with radiation therapy. We have developed an IMRT-based technique, termed CEST, to reduce the radiation dose to the part of the esophagus that is located opposite to the tumor. The reason behind this approach is that a lower radiation dose causes less esophagus inflammation and irritation and, therefore, may preserve the swallowing function of the esophagus better. In our clinical experience, reducing the radiation dose to part of the esophagus in this fashion has shown the potential to dramatically decrease the likelihood of severe esophagitis in many though not all people with lung cancer. We therefore wish to analyze this technique further.
There is no firm data to indicate that different chemotherapy regimens given at the same time of radiation therapy result in different rates of esophagitis. The Investigators will, therefore, allow any type of standard-of-care chemotherapy regimen at the discretion of the patient's medical oncologist.
- Being tested
- Contralateral Esophageal Sparing Technique (CEST)
- Keywords
- Locally advanced, inoperable non-small cell lung carcinoma, Limited stage small cell lung carcinoma, Acute esophagitis, Intensity-modulated radiation therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contralateral Esophageal Sparing Technique (CEST)Radiation
Determine whether CEST decreases rate of severe acute esophagitis
| Study group | Role | What they receive |
|---|---|---|
| Contralateral Esophagus Sparing Technique (CEST) | Experimental | IMRT with CEST and concurrent chemotherapy (any standard-of-care regimen) Receives: Radiation: Contralateral Esophageal Sparing Technique (CEST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Grade 3 or Higher Acute Esophagitis (CTCAE)
Esophagitis will be measured using the Common Toxicity Criteria for Adverse Effects (CTCAE) v4 scoring scale
Measured: up to 3 months
Secondary outcomes (4)
Number of Participants With Grade 3 or Higher Acute Esophagitis (RTOG)
Esophagitis will be measured using the historical Radiation Therapy Oncology Group (RTOG) scoring scale
Measured: Baseline , up to 3 Months
Number of Participants With Adverse Events
Adverse events will be measured using CTCAE v4 scoring scale
Measured: Baseline, up to 2 Years
Rate of Local and Regional Failure
Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline. No isolated locoregional tumor failures at a median follow-up of up to 2 years.
Measured: Median follow-up of up to 2 years
Overall Survival Rate
Follow-up time will be calculated from the date of registration to the date of death or the last follow-up date on which the patient was reported alive. Overall survival rates will be estimated using the Kaplan-Meier method.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startJun 2015
- Primary completionFeb 2019
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henning Willers, M.D., Massachusetts General Hospital
- Investigators
- Henning Willers, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394548
- Sponsor's protocol ID
- 15-023
- Status last verified
- Dec 2021
- First submitted
- 16 Mar 2015
- Last updated
- 9 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kamran SC, Yeap BY, Ulysse CA, Cronin C, Bowes CL, Durgin B, Gainor JF, Khandekar MJ, Tansky JY, Keane FK, Olsen CC, Willers H. Assessment of a Contralateral Esophagus-Sparing Technique in Locally Advanced Lung Cancer Treated With High-Dose Chemoradiation: A Phase 1 Nonrandomized Clinical Trial. JAMA Oncol. 2021 Jun 1;7(6):910-914. doi: 10.1001/jamaoncol.2021.0281.
PubMed 33830168
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial Of Intensity-Modulated Radiation Therapy (IMRT) Using A Contralateral Esophagus Sparing Technique (CEST) In Locally Advanced Non-Small Cell Lung Cancer (NSCLC) And Limited-Stage Small Cell Lung Cancer (LS-SCLC).
- ClinicalTrials.gov ID
- NCT02394548
- Acronym / sponsor ID
- 15-023
- Keywords
- Locally advanced, inoperable non-small cell lung carcinoma, Limited stage small cell lung carcinoma, Acute esophagitis, Intensity-modulated radiation therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Feb 2019 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 20 Mar 2015 (estimated)
- Results
- Posted 24 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is examining the benefit of a novel radiation planning approach on the likelihood of developing severe esophagitis (irritation and inflammation of the esophagus) during the course of radiation therapy with concurrent chemotherapy which is associated with very painful and difficult swallowing.
Detailed description
This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied.
The U.S. Food and Drug Administration (FDA) has approved radiation with chemotherapy as a treatment option for your disease.
Currently, there are no established rules to avoid esophagitis in the treatment of lung cancer with radiation therapy. We have developed an IMRT-based technique, termed CEST, to reduce the radiation dose to the part of the esophagus that is located opposite to the tumor. The reason behind this approach is that a lower radiation dose causes less esophagus inflammation and irritation and, therefore, may preserve the swallowing function of the esophagus better. In our clinical experience, reducing the radiation dose to part of the esophagus in this fashion has shown the potential to dramatically decrease the likelihood of severe esophagitis in many though not all people with lung cancer. We therefore wish to analyze this technique further.
There is no firm data to indicate that different chemotherapy regimens given at the same time of radiation therapy result in different rates of esophagitis. The Investigators will, therefore, allow any type of standard-of-care chemotherapy regimen at the discretion of the patient's medical oncologist.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contralateral Esophagus Sparing Technique (CEST) | Experimental | Radiation: Contralateral Esophageal Sparing Technique (CEST)IMRT with CEST and concurrent chemotherapy (any standard-of-care regimen) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Participants must meet the following criteria on screening examination to be eligible to participate in the study.
- Histologically or cytologically proven diagnosis of NSCLC or SCLC
- NSCLC, patients with clinical stage IIB-IV patients (AJCC, 7th ed.) are eligible, and for SCLC, limited-stage patients are eligible, if documented to be a candidate for definitive radiation and concurrent chemotherapy in the radiation oncologist or medical oncologist clinic note.
- Gross tumor (primary tumor or involved lymph node) must be within 1 cm of esophagus on the most recent chest CT scan.
- ECOG performance status 0-1 within 30 days prior to registration;
Key exclusion criteria (8 listed)
- Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
- Greater than minimal, exudative, or cytologically positive pleural effusions
- Tumor suspected or known to invade the esophagus
- Prior chemotherapy if this precludes administration of concurrent chemotherapy for protocol treatment. Note that induction chemotherapy is allowed as long as concurrent chemotherapy is possible.
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
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 |
|---|---|---|
| Contralateral Esophageal Sparing Technique (CEST)Determine whether CEST decreases rate of severe acute esophagitis | Radiation | Contralateral Esophagus Sparing Technique (CEST) |
Primary outcome
Number of Participants With Grade 3 or Higher Acute Esophagitis (CTCAE)
Time frame: up to 3 months
Esophagitis will be measured using the Common Toxicity Criteria for Adverse Effects (CTCAE) v4 scoring scale
4 secondary outcomes
Number of Participants With Grade 3 or Higher Acute Esophagitis (RTOG)
Time frame: Baseline , up to 3 Months
Number of Participants With Adverse Events
Time frame: Baseline, up to 2 Years
Rate of Local and Regional Failure
Time frame: Median follow-up of up to 2 years
Overall Survival Rate
Time frame: 2 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33830168Kamran SC, Yeap BY, Ulysse CA, Cronin C, Bowes CL, Durgin B, Gainor JF, Khandekar MJ, Tansky JY, Keane FK, Olsen CC, Willers H. Assessment of a Contralateral Esophagus-Sparing Technique in Locally Advanced Lung Cancer Treated With High-Dose Chemoradiation: A Phase 1 Nonrandomized Clinical Trial. JAMA Oncol. 2021 Jun 1;7(6):910-914. doi: 10.1001/jamaoncol.2021.0281.
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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.
Henning Willers, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contralateral Esophageal Sparing Technique (CEST) in people with Non-small Cell Lung Carcinoma and Small Cell Lung Carcinoma, run by Massachusetts General Hospital at 2 sites 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 14 inclusion and 8 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 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 24 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Grade 3 or Higher Acute Esophagitis (CTCAE) (time frame: up to 3 months). 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 NCT02394548, 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 9 Dec 2021.