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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT02130427
First received: May 1, 2014
Last updated: January 24, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention
Biopsy Proven Non Small Cell Lung Cancer
Head and Neck Cancer
Gastrointestinal Cancer
Colorectal Cancer
Rectal Cancers
Gynecological Malignancy Requiring Definitive Radiotherapy
Radiation: Radiation Therapy

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: A Volume, Motion, and Anatomically Adaptive Approach to Photon and Proton Beam Radiotherapy

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Number of Adverse Events [ Time Frame: 4-6 weeks ]

Estimated Enrollment: 120
Study Start Date: September 2010
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NSCLC Radiation: Radiation Therapy
Experimental: Head & Neck Radiation: Radiation Therapy
Experimental: GI Radiation: Radiation Therapy
Experimental: Gynecologic Radiation: Radiation Therapy

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02130427

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: Charles Simone, MD Abramson Cancer Center of the University of Pennsylvania
  More Information

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02130427     History of Changes
Other Study ID Numbers: UPCC 08909
Study First Received: May 1, 2014
Last Updated: January 24, 2017

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Adult subjects
NSCLC

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Rectal Neoplasms
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 25, 2017