Lung CancerPhase 1NCT03094884
Pulsed Low Dose Rate Radiation With Concurrent Chemotherapy for Non-Small Cell Lung Cancer and Esophageal Cancer
A Phase 1 study testing Pulsed Low Dose Radiation, Carboplatin and Paclitaxel in people with Lung Cancer and Esophageal Cancer, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
Phase I study with the hypothesis that Pulsed Low Dose Radiation (PLDR) radiation delivery technique can significantly decrease the rate of severe acute esophagitis in patients receiving concurrent Chemo-radiation therapy (CRT) for non-small cell lung cancer or esophageal cancer while maintaining similar efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Esophageal Cancer
- What is being tested?
- Pulsed Low Dose Radiation, Carboplatin and Paclitaxel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2017to 1 May 2025
- 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
- Patient must have pathologically-confirmed and previously untreated:
- Non-small cell lung cancer, Stage IIIA (T1-3 N2 M0); OR
- Localized esophageal cancer, ≥T2, or N+, and M0 according to the American Joint Committee on Cancer (AJCC) 7th edition staging.
- The planned treatment regimen must be concurrent chemoradiation with Carboplatin-Paclitaxel followed by surgery.
- Age > 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status is 0-1.
Show all 16Show fewer
- Laboratory studies must meet each of the following criteria (with labs drawn within 4 weeks prior to the registration):
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
- Platelets ≥100,000 cells/mm3
- Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable)
- Creatinine ≤2 X the upper limit of normal
- Bilirubin ≤ 1.5 X upper limit of normal
- Aspartate transaminase (AST) ≤ 3 X upper limit of normal
- Men and women of childbearing potential must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy completed.
- Patients must be able to read and write English to comply with the questionnaire portions of the protocol.
- Subjects must sign a written informed study consent and HIPAA consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up.
Who cannot join
- Patients who have had previous radiotherapy in the thorax.
- Patients who have a history of ataxia telangiectasia or other documented history of radiation hypersensitivity.
- Patients who have a history scleroderma or other active connective tissue disease.
- Women of childbearing potential must not be pregnant with a negative urine pregnancy test within 72 hours prior to registration and non-lactating; postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential; woman status post oophorectomy or hysterectomy are considered non-childbearing potential
- Patients who have uncontrolled inter-current illness including, but not limited to, psychiatric illness/social situations that would limit compliance with study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Joshua Meyer, MD, 215-214-1515, joshua.meyer@fccc.edu
About this study
Phase I study with the hypothesis that Pulsed Low Dose Radiation (PLDR) radiation delivery technique can significantly decrease the rate of severe acute esophagitis in patients receiving concurrent Chemo-radiation therapy (CRT) for non-small cell lung cancer or esophageal cancer while maintaining similar efficacy. For these patients, the rate of severe acute esophagitis during concurrent CRT is high (approximately 20%) when conventional external beam radiation is utilized. Severe acute esophagitis can cause many adverse consequences such as severe discomfort, weight loss, hospitalization, interruption/early termination of treatment, and worse surgical complications for those who receive surgery after CRT. PLDR radiation has the potential to maintain the tumor control rates of conventional radiation while decreasing the toxicity to the surrounding normal tissue 29-35.
We have completed accrual to a phase I PLDR radiation study, in which patient received palliative re-irradiation with PLDR technique for their metastatic disease in previous irradiated field. In that phase I study, PLDR demonstrated safety for acute toxicities in the setting of re-irradiation for a total dose of 50 Gy, with analysis of 60 Gy pending. The follow up time for that phase I study is limited as most enrolled patients have short overall survival due to their terminal illness.
This proposed phase I study is, to our knowledge, the first clinical study with combination of PLDR radiation and concurrent chemotherapy for definitive treatment.
- Conditions
- Lung Cancer, Esophageal Cancer
- Being tested
- Pulsed Low Dose Radiation, Carboplatin, Paclitaxel
- Medical subject headings
- Lung Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Low Dose RadiationRadiation
Treatment naïve patients with non-small cell lung cancer or esophageal cancer whose planned treatment regimen is concurrent CRT followed by surgery. The total radiation dose will be 50.4 Gy in daily fraction of 1.8 Gy for esophageal cancer and 60 Gy in daily fraction of 2 Gy for non-small cell lung cancer. The concurrent chemo regimen will carboplatin-paclitaxel managed by the treating medical oncologist. Patients are planned to receive surgery at approximately 6 to 9 weeks after finishing CRT with surgical aspects determined by the treating surgical oncologist.
CarboplatinDrug
Treatment naïve patients with non-small cell lung cancer or esophageal cancer whose planned treatment regimen is concurrent CRT followed by surgery. The total radiation dose will be 50.4 Gy in daily fraction of 1.8 Gy for esophageal cancer and 60 Gy in daily fraction of 2 Gy for non-small cell lung cancer. The concurrent chemo regimen will carboplatin-paclitaxel managed by the treating medical oncologist. Patients are planned to receive surgery at approximately 6 to 9 weeks after finishing CRT with surgical aspects determined by the treating surgical oncologist.
PaclitaxelDrug
Treatment naïve patients with non-small cell lung cancer or esophageal cancer whose planned treatment regimen is concurrent CRT followed by surgery. The total radiation dose will be 50.4 Gy in daily fraction of 1.8 Gy for esophageal cancer and 60 Gy in daily fraction of 2 Gy for non-small cell lung cancer. The concurrent chemo regimen will carboplatin-paclitaxel managed by the treating medical oncologist. Patients are planned to receive surgery at approximately 6 to 9 weeks after finishing CRT with surgical aspects determined by the treating surgical oncologist.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Low dose radiation with Carboplatin/Paclitaxel | Experimental | Pulsed Low Dose Radiation concurrent with Carboplatin and Paclitaxel Receives: Radiation: Pulsed Low Dose Radiation; Drug: Carboplatin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of severe acute esophagitis in patients with lung cancer and esophageal cancer treated with concurrent CRT using PLDR technique.
The investigator will evaluate the severity of other adverse events using the NCI Common Terminology Criteria for Adverse Events (CTCAE v.4.0).
Measured: 2 years
Secondary outcomes (3)
Quality of life
Quality of life will be evaluated based on a quality of life survey conducted at different time-points during the study. After entering in the study survey will be conducted in 1st month , 2nd month ,3rd month, 6th month, 9th month. Number of surveys conducted will be the same however a delay due toxicity is possible and therefore last survey could be collected up to 12 months.
Measured: 1 year
Progression free survival
progression free survival will be evaluated from the day of first treatment until disease progression
Measured: 1-5 years
Response rate based
Response rate will be evaluated based on the outcome of surgical pathology
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start24 Feb 2017
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2025 (estimated)
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.
- More trials run by Fox Chase 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua Meyer, MD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094884
- Sponsor's protocol ID
- RT-101
- Status last verified
- May 2023
- First submitted
- 23 Mar 2017
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Low Dose Rate Radiation With Concurrent Chemotherapy for Non-Small Cell Lung Cancer and Esophageal Cancer
- ClinicalTrials.gov ID
- NCT03094884
- Acronym / sponsor ID
- RT-101
- Conditions
- Lung Cancer, Esophageal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Study start
- 24 Feb 2017 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 29 Mar 2017 (actual)
- 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.
Phase I study with the hypothesis that Pulsed Low Dose Radiation (PLDR) radiation delivery technique can significantly decrease the rate of severe acute esophagitis in patients receiving concurrent Chemo-radiation therapy (CRT) for non-small cell lung cancer or esophageal cancer while maintaining similar efficacy. For these patients, the rate of severe acute esophagitis during concurrent CRT is high (approximately 20%) when conventional external beam radiation is utilized. Severe acute esophagitis can cause many adverse consequences such as severe discomfort, weight loss, hospitalization, interruption/early termination of treatment, and worse surgical complications for those who receive surgery after CRT. PLDR radiation has the potential to maintain the tumor control rates of conventional radiation while decreasing the toxicity to the surrounding normal tissue 29-35.
We have completed accrual to a phase I PLDR radiation study, in which patient received palliative re-irradiation with PLDR technique for their metastatic disease in previous irradiated field. In that phase I study, PLDR demonstrated safety for acute toxicities in the setting of re-irradiation for a total dose of 50 Gy, with analysis of 60 Gy pending. The follow up time for that phase I study is limited as most enrolled patients have short overall survival due to their terminal illness.
This proposed phase I study is, to our knowledge, the first clinical study with combination of PLDR radiation and concurrent chemotherapy for definitive treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulsed Low dose radiation with Carboplatin/Paclitaxel | Experimental | Radiation: Pulsed Low Dose Radiation, Drug: Carboplatin, Drug: PaclitaxelPulsed Low Dose Radiation concurrent with Carboplatin and Paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patient must have pathologically-confirmed and previously untreated:
- The planned treatment regimen must be concurrent chemoradiation with Carboplatin-Paclitaxel followed by surgery.
- Age > 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status is 0-1.
- Laboratory studies must meet each of the following criteria (with labs drawn within 4 weeks prior to the registration):
Key exclusion criteria (5 listed)
- Patients who have had previous radiotherapy in the thorax.
- Patients who have a history of ataxia telangiectasia or other documented history of radiation hypersensitivity.
- Patients who have a history scleroderma or other active connective tissue disease.
- Women of childbearing potential must not be pregnant with a negative urine pregnancy test within 72 hours prior to registration and non-lactating; postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential; woman status post oophorectomy or hysterectomy are considered non-childbearing potential
- Patients who have uncontrolled inter-current illness including, but not limited to, psychiatric illness/social situations that would limit compliance with study requirements.
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 |
|---|---|---|
| Pulsed Low Dose RadiationTreatment naïve patients with non-small cell lung cancer or esophageal cancer whose planned treatment regimen is concurrent CRT followed by surgery. The total radiation dose will be 50.4 Gy in daily fraction of 1.8 Gy for esophageal cancer and 60 Gy in daily fraction of 2 Gy for non-small cell lung cancer. The concurrent chemo regimen will carboplatin-paclitaxel managed by the treating medical oncologist. Patients are planned to receive surgery at approximately 6 to 9 weeks after finishing CRT with surgical aspects determined by the treating surgical oncologist. | Radiation | Pulsed Low dose radiation with Carboplatin/Paclitaxel |
| CarboplatinTreatment naïve patients with non-small cell lung cancer or esophageal cancer whose planned treatment regimen is concurrent CRT followed by surgery. The total radiation dose will be 50.4 Gy in daily fraction of 1.8 Gy for esophageal cancer and 60 Gy in daily fraction of 2 Gy for non-small cell lung cancer. The concurrent chemo regimen will carboplatin-paclitaxel managed by the treating medical oncologist. Patients are planned to receive surgery at approximately 6 to 9 weeks after finishing CRT with surgical aspects determined by the treating surgical oncologist. | Drug | Pulsed Low dose radiation with Carboplatin/Paclitaxel |
| PaclitaxelTreatment naïve patients with non-small cell lung cancer or esophageal cancer whose planned treatment regimen is concurrent CRT followed by surgery. The total radiation dose will be 50.4 Gy in daily fraction of 1.8 Gy for esophageal cancer and 60 Gy in daily fraction of 2 Gy for non-small cell lung cancer. The concurrent chemo regimen will carboplatin-paclitaxel managed by the treating medical oncologist. Patients are planned to receive surgery at approximately 6 to 9 weeks after finishing CRT with surgical aspects determined by the treating surgical oncologist. | Drug | Pulsed Low dose radiation with Carboplatin/Paclitaxel |
Primary outcome
Rate of severe acute esophagitis in patients with lung cancer and esophageal cancer treated with concurrent CRT using PLDR technique.
Time frame: 2 years
The investigator will evaluate the severity of other adverse events using the NCI Common Terminology Criteria for Adverse Events (CTCAE v.4.0).
3 secondary outcomes
Quality of life
Time frame: 1 year
Progression free survival
Time frame: 1-5 years
Response rate based
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Individual participant dataSharing planned: No
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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.
Joshua Meyer, MD principal investigator
Fox Chase 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 Pulsed Low Dose Radiation, Carboplatin and Paclitaxel in people with Lung Cancer and Esophageal Cancer, run by Fox Chase 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 16 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joshua Meyer, MD (215-214-1515, joshua.meyer@fccc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of severe acute esophagitis in patients with lung cancer and esophageal cancer treated with concurrent CRT using PLDR technique. (time frame: 2 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 23 May 2023.