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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 is a clinical trial that has completed, run by Fox Chase Cancer Center. The registered enrollment target is 6 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03095209
The ClinicalTrials.gov registry entry for NCT03095209 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fox Chase Cancer Center, which has 183 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Carboplatin is the first listed.
NCT03095209 reports 0 study locations.
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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