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NCT03095209 · ClinicalTrials.gov registry record
Observation Study of Patients With Non-Small Cell Lung Cancer and Esophageal Cancer Treated With Chemo-Radiation Followed by Surgery
A clinical trial, sponsored by Fox Chase Cancer Center.
- Completed
- Registry status
- 6
- Enrollment target
NCT03095209: Completed study, sponsored by Fox Chase Cancer Center.
NCT03095209 is a clinical trial that has completed, run by Fox Chase Cancer Center. The registered enrollment target is 6 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03095209 has completed, sponsored by Fox Chase Cancer Center.
- COMPLETED
- Registry status
- 6 participants
- Enrollment target
Study 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. 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.
Primary Outcome
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
Interventions
- DRUG Carboplatin
- DRUG Paclitaxel
- RADIATION Radiation Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2017-02-24 |
| Est. Completion | 2021-01-18 |
What the finished NCT03095209 record still lists
NCT03095209 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 6 participants, a relatively small participant target.
The record links to 0 conditions, and to 3 interventions - of which Carboplatin is the first listed.
NCT03095209 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03095209 about?
NCT03095209 is a clinical study titled "Observation Study of Patients With Non-Small Cell Lung Cancer and Esophageal Cancer Treated With Chemo-Radiation Followed by Surgery". 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...
What is the current status of trial NCT03095209?
This trial is currently completed. The enrollment target is 6 participants. The study started on 2017-02-24. Estimated completion is 2021-01-18.
What interventions are being tested in trial NCT03095209?
The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT03095209?
This trial is sponsored by Fox Chase Cancer Center, which has 183 total clinical trials registered on ClinicalTrials.gov.
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