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

NCT02130427 | Completed Results DMC

• 1 other identifier: UPCC 08909
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  9 weeks

Study Arms (1)

Lung Imaging

OTHER

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.

Diagnostic Test: CT scan

Interventions

CT scan DIAGNOSTIC_TEST

Weekly 3D/4D CT scan

Lung Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Gastrointestinal Neoplasms; Colorectal Neoplasms; Rectal Neoplasms

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Results Point of Contact

• Title: Dr. Wei Zou
• Organization: University of Pennsylvania

Wei.Zou@pennmedicine.upenn.edu

800-789-7366

Study Officials

• Jennifer Wei Zou, PhD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot study

Study Record Dates

• First Submitted: May 1, 2014
• First Posted: May 5, 2014
• Study Start: September 1, 2010
• Primary Completion: October 1, 2019
• Study Completion: April 1, 2022
• Last Updated: July 22, 2022
• Results First Posted: July 1, 2021

Record last verified: 2022-07

Locations

US (1)