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A Volume, Motion, and Anatomically Adaptive Approach to Photon and Proton Beam Radiotherapy

Primary Purpose

Biopsy Proven Non Small Cell Lung Cancer, Head and Neck Cancer, Gastrointestinal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CT scan
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Biopsy Proven Non Small Cell Lung Cancer focused on measuring Adult subjects, NSCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 18 and above.
  • Biopsy proven diagnosis of non-small cell lung cancer, small cell lung cancer, head and neck, esophageal, gastric, pancreatic, anal, hepatic, biliary, colorectal, cervical, endometrial, vaginal, vulvar, ovarian cancer and any other gastrointestinal or gynecological cancers requiring definitive radiotherapy alone with or without concurrent chemotherapy.
  • Able to provide written informed consent and comply with all study procedures.
  • Entire course of radiotherapy will be delivered at the University of Pennsylvania Perelman Center for Advanced Medicine.

Exclusion Criteria:

- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.

Sites / Locations

  • Abramson Cancer Center of the University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Lung Imaging

Arm Description

Weekly 3D/4D CT scans during radiation therapy. MRI may be used in addition to or instead of CT depending on the location of the tumor and the decision of the treating physician.

Outcomes

Primary Outcome Measures

Tumor Volume
The degree of tumor volume, tumor motion and patient anatomy change during treatment with photon beam radiotherapy using 4D or 3D CT Scans and/or a serial of MR Imaging.

Secondary Outcome Measures

Full Information

First Posted
May 1, 2014
Last Updated
July 15, 2022
Sponsor
Abramson Cancer Center at Penn Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02130427
Brief Title
A Volume, Motion, and Anatomically Adaptive Approach to Photon and Proton Beam Radiotherapy
Official Title
A Volume, Motion, and Anatomically Adaptive Approach to Photon and Proton Beam Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 2010 (Actual)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
April 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This pilot study will determine changes over time in tumor volume/motion & patient anatomy, as well as dose distributions to normal organs. The study will inform medical decision-making about need for (and timing of) re-calibration of radiation dosimetry plans. Weekly CT and/or serial MR scans will be employed for those patients receiving 7-8 wks of radiation therapy. The study will enroll 30 patients in each stratum: Non small cell lung cancer (NSCLC), Head & Neck, gastrointestinal (GI) and Gynecologic tumor.
Detailed Description
This is a pilot study to estimate the degree of tumor volume, tumor motion and patient anatomy change during treatment with photon or proton beam radiotherapy. Patients will undergo simulation with an MR scan and/or CT scan per best clinical practices, and 4D imaging will be employed as indicated, at the discretion of the treating radiation oncologist. Photon beam treatment plans and Proton beam treatment plans will be generated from these images. Based on the location of the primary tumor, patients will undergo either up to weekly 3D or 4D CT and/or serial MR scans during treatment. These images will be compared to the initial CT/MR scans used for treatment planning and analyzed for changes in tumor volume and tumor anatomic location. At the end of treatment, the frequent 3D or 4D CT and/or serial MR images will be compared to the initial treatment planning images to quantify the changes in tumor volume and tumor motion during the course of radiation treatment. Each CT and/or MR Scan will also be used to evaluate the changes in dose distribution to the target volumes and normal tissues that occur with the initial photon treatment plan and initial proton treatment. The changes in tumor volume, tumor motion and dose distribution during the course of radiation treatment will be analyzed to determine the effect of tumor changes on radiation treatment efficacy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biopsy Proven Non Small Cell Lung Cancer, Head and Neck Cancer, Gastrointestinal Cancer, Colorectal Cancer, Rectal Cancers, Gynecological Malignancy Requiring Definitive Radiotherapy
Keywords
Adult subjects, NSCLC

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lung Imaging
Arm Type
Other
Arm Description
Weekly 3D/4D CT scans during radiation therapy. MRI may be used in addition to or instead of CT depending on the location of the tumor and the decision of the treating physician.
Intervention Type
Diagnostic Test
Intervention Name(s)
CT scan
Intervention Description
Weekly 3D/4D CT scan
Primary Outcome Measure Information:
Title
Tumor Volume
Description
The degree of tumor volume, tumor motion and patient anatomy change during treatment with photon beam radiotherapy using 4D or 3D CT Scans and/or a serial of MR Imaging.
Time Frame
9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18 and above. Biopsy proven diagnosis of non-small cell lung cancer, small cell lung cancer, head and neck, esophageal, gastric, pancreatic, anal, hepatic, biliary, colorectal, cervical, endometrial, vaginal, vulvar, ovarian cancer and any other gastrointestinal or gynecological cancers requiring definitive radiotherapy alone with or without concurrent chemotherapy. Able to provide written informed consent and comply with all study procedures. Entire course of radiotherapy will be delivered at the University of Pennsylvania Perelman Center for Advanced Medicine. Exclusion Criteria: - Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Wei Zou, PhD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Volume, Motion, and Anatomically Adaptive Approach to Photon and Proton Beam Radiotherapy

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