Observation Study of Patients With Non-Small Cell Lung Cancer and Esophageal Cancer Treated With Chemo-Radiation Followed by Surgery

Sponsor
Fox Chase Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT03095209
Collaborator
(none)
6
1
46.8
0.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
6 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Observation Study of Patients With Non-Small Cell Lung Cancer and Esophageal Cancer Treated With Chemo-Radiation Followed by Surgery
Actual Study Start Date :
Feb 24, 2017
Actual Primary Completion Date :
Nov 20, 2019
Actual Study Completion Date :
Jan 18, 2021

Arms and Interventions

Arm Intervention/Treatment
Standard of care concurrent chemo-radiation therapy

Drug: Carboplatin
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.

Drug: Paclitaxel
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: Radiation Therapy
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.

Outcome Measures

Primary Outcome Measures

  1. Serum inflammation markers [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

Secondary Outcome Measures

  1. Quality of life and pain [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. 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.

  1. The planned treatment regimen must be concurrent chemoradiation with Carboplatin-Paclitaxel followed by surgery.

  2. Age > 18 years.

  3. ECOG performance status is 0-1.

  4. 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

  1. 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.

  2. Patients must be able to read and write English to comply with the questionnaire portions of the protocol.

  3. 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.

Exclusion Criteria:
  1. Patients who have had previous radiotherapy in the thorax.

  2. Patients who have a history of ataxia telangiectasia or other documented history of radiation hypersensitivity.

  3. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111

Sponsors and Collaborators

  • Fox Chase Cancer Center

Investigators

  • Principal Investigator: Joshua Meyer, MD, Fox Chase Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT03095209
Other Study ID Numbers:
  • RT-103
First Posted:
Mar 29, 2017
Last Update Posted:
Oct 12, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 12, 2021