Lung CancerNCT03095209
Observation Study of Patients With Non-Small Cell Lung Cancer and Esophageal Cancer Treated With Chemo-Radiation Followed by Surgery
An observational study of Lung Cancer and Esophageal Cancer, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
Patients on this observation study must have planned treatment regimen with concurrent CRT followed by planned surgery, which is considered as standard of care for their disease. 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?
- Carboplatin, Paclitaxel and Radiation Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2017to 18 Jan 2021
- Phase
- Observational
- 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
Study population: Patients who are eligible for the phase I trial (RT-101) but decline to enroll should be offered to participate in this parallel observation study. Patients with the following disease will be included in this observation study: I. non-small cell lung cancer, Stage IIIA (T1-3 N2 M0) II. localized esophageal cancer, ≥T2, or N+, and M0 Patients on this observation study must have planned treatment regimen with concurrent CRT followed by planned surgery, which is considered as standard of care for their disease.
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.
- 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
- 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.
- 9 Women of childbearing potential must not be pregnant and non-lactating. They are required to have a negative serum pregnancy test within 72 hours prior to registration or they can decline the pregnancy test with the specific supporting reason such as not sexually active or using birth control; 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.
- 4 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
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Patients on this observation study must have planned treatment regimen with concurrent CRT followed by planned surgery, which is considered as standard of care for their disease. 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 (maximum 12 weeks post-CRT) after finishing CRT with surgical aspects determined by the treating surgical oncologist.
Patients on this observation study will donate their blood samples within 4 weeks before initiating CRT, within 1 week before completing CRT, 1 month after CRT, and 1 month after surgery (or 3 months after CRT if surgery is not done for any reason). They are also requested to fill out questionnaires (EORTC QLQ-30, EORTC QLQ-OES18, and Pain Scale as attached) prior to CRT, weekly during CRT, 1 month after CRT, 1 month after surgery (or 3 months after CRT if surgery is not done for any reason), and 6 months after CRT. Any patients with incomplete treatment will have samples collected up to the point where they discontinue. The specimen collection, handling and processing will be done by Protocol Support Lab (PSL) at Fox Chase Cancer Center under the directions of the Director, R. Katherine Alpaugh, PhD, following the procedures outlined in PSL lab manual. The patients in this observation study will be asked to donate a tissue specimen after the definitive surgery for investigation.
- Conditions
- Lung Cancer, Esophageal Cancer
- Being tested
- Carboplatin, Paclitaxel, Radiation Therapy
- 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.
CarboplatinDrug
chemo regimen will carboplatin-paclitaxel managed by the treating medical oncologist. Patients are planned to receive surgery at approximately 6 to 9 weeks (maximum 12 weeks post-CRT) after finishing CRT with surgical aspects determined by the treating surgical oncologist.
PaclitaxelDrug
chemo regimen will carboplatin-paclitaxel managed by the treating medical oncologist. Patients are planned to receive surgery at approximately 6 to 9 weeks (maximum 12 weeks post-CRT) after finishing CRT with surgical aspects determined by the treating surgical oncologist.
Radiation TherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care concurrent chemo-radiation therapy | Not described Receives: Drug: Carboplatin; Drug: Paclitaxel; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum inflammation markers
Serum inflammation markers will be analyzed that will serve as the control for the parallel study RT-101. In the 7 month period the blood will be drawn once during the following months - 1, 2,3, 7
Measured: 7 months
Secondary outcomes (1)
Quality of life and pain
Quality of life will be assessed in the form of surveys which reveal the ability to complete daily activities the pain level of the patient. During the study the surveys will be conducted in the following months- month1, month 2 (every week that is 4 times), month 3, month 7 and month 9. If there are delays due to toxicities the survey collection timelines can shift and the last survey could be collected up to 12 months. The number of surveys collected will be the same.
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 completion20 Nov 2019
- Study completion18 Jan 2021
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
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
- NCT03095209
- Sponsor's protocol ID
- RT-103
- Status last verified
- Oct 2021
- First submitted
- 23 Mar 2017
- Last updated
- 12 Oct 2021
- 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 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation Study of Patients With Non-Small Cell Lung Cancer and Esophageal Cancer Treated With Chemo-Radiation Followed by Surgery
- ClinicalTrials.gov ID
- NCT03095209
- Acronym / sponsor ID
- RT-103
- Conditions
- Lung Cancer, Esophageal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Study start
- 24 Feb 2017 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 18 Jan 2021 (actual)
- 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.
Patients on this observation study must have planned treatment regimen with concurrent CRT followed by planned surgery, which is considered as standard of care for their disease. 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 (maximum 12 weeks post-CRT) after finishing CRT with surgical aspects determined by the treating surgical oncologist.
Patients on this observation study will donate their blood samples within 4 weeks before initiating CRT, within 1 week before completing CRT, 1 month after CRT, and 1 month after surgery (or 3 months after CRT if surgery is not done for any reason). They are also requested to fill out questionnaires (EORTC QLQ-30, EORTC QLQ-OES18, and Pain Scale as attached) prior to CRT, weekly during CRT, 1 month after CRT, 1 month after surgery (or 3 months after CRT if surgery is not done for any reason), and 6 months after CRT. Any patients with incomplete treatment will have samples collected up to the point where they discontinue. The specimen collection, handling and processing will be done by Protocol Support Lab (PSL) at Fox Chase Cancer Center under the directions of the Director, R. Katherine Alpaugh, PhD, following the procedures outlined in PSL lab manual. The patients in this observation study will be asked to donate a tissue specimen after the definitive surgery for investigation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard of care concurrent chemo-radiation therapy | – | Drug: Carboplatin, Drug: Paclitaxel, Radiation: Radiation Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are eligible for the phase I trial (RT-101) but decline to enroll should be offered to participate in this parallel observation study. Patients with the following disease will be included in this observation study: I. non-small cell lung cancer, Stage IIIA (T1-3 N2 M0) II. localized esophageal cancer, ≥T2, or N+, and M0 Patients on this observation study must have planned treatment regimen with concurrent CRT followed by planned surgery, which is considered as standard of care for their disease.
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.
- 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.
- 9 Women of childbearing potential must not be pregnant and non-lactating. They are required to have a negative serum pregnancy test within 72 hours prior to registration or they can decline the pregnancy test with the specific supporting reason such as not sexually active or using birth control; 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.
- 4 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 |
|---|---|---|
| Carboplatinchemo regimen will carboplatin-paclitaxel managed by the treating medical oncologist. Patients are planned to receive surgery at approximately 6 to 9 weeks (maximum 12 weeks post-CRT) after finishing CRT with surgical aspects determined by the treating surgical oncologist. | Drug | Standard of care concurrent chemo-radiation therapy |
| Paclitaxelchemo regimen will carboplatin-paclitaxel managed by the treating medical oncologist. Patients are planned to receive surgery at approximately 6 to 9 weeks (maximum 12 weeks post-CRT) after finishing CRT with surgical aspects determined by the treating surgical oncologist. | Drug | Standard of care concurrent chemo-radiation therapy |
| Radiation TherapyThe 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. | Radiation | Standard of care concurrent chemo-radiation therapy |
Primary outcome
Serum inflammation markers
Time frame: 7 months
Serum inflammation markers will be analyzed that will serve as the control for the parallel study RT-101. In the 7 month period the blood will be drawn once during the following months - 1, 2,3, 7
1 secondary outcome
Quality of life and pain
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- 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?
An observational study of 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: finished, as of the sponsor's last update on 12 Oct 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serum inflammation markers (time frame: 7 months). 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 12 Oct 2021.