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

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ClinicalTrials.gov Identifier: NCT02130427
Recruitment Status : Active, not recruiting
First Posted : May 5, 2014
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Primary Purpose: Diagnostic
Official Title: A Volume, Motion, and Anatomically Adaptive Approach to Photon and Proton Beam Radiotherapy
Study Start Date : September 2010
Estimated Primary Completion Date : August 2018

Arm Intervention/treatment
Experimental: NSCLC Radiation: Radiation Therapy
Experimental: Head & Neck Radiation: Radiation Therapy
Experimental: GI Radiation: Radiation Therapy
Experimental: Gynecologic Radiation: Radiation Therapy



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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02130427     History of Changes
Other Study ID Numbers: UPCC 08909
First Posted: May 5, 2014    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: July 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
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