Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
NCT Number: NCT03095209
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Philadelphia, Pennsylvania, 19111, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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
Time frame: 1 year
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.
Fox Chase Cancer Center
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05708950
Adnexal Diseases, Breast Cancer
Santa Monica, California, United States
View Trial DetailsNCT05787522
Breast Cancer, Breast Diseases
Tianjin, Tianjin Municipality, China
View Trial DetailsNCT04825834
Bladder Cancer, Colonic Diseases
Homewood, Alabama, United States
View Trial DetailsNCT05697198
Adnexal Diseases, Breast Cancer
Fort Payne, Alabama, United States
View Trial Details