This trial is active, not recruiting.

Conditions biopsy proven non small cell lung cancer, head and neck cancer, gastrointestinal cancer, colorectal cancer, rectal cancers, gynecological malignancy requiring definitive radiotherapy
Treatment radiation therapy
Sponsor Abramson Cancer Center of the University of Pennsylvania
Start date September 2010
End date August 2014
Trial size 120 participants
Trial identifier NCT02130427, UPCC 08909


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose diagnostic
radiation therapy
radiation therapy
radiation therapy
radiation therapy

Primary Outcomes

Number of Adverse Events
time frame: 4-6 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Volume, Motion, and Anatomically Adaptive Approach to Photon and Proton Beam Radiotherapy
Principal investigator Charles Simone, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Abramson Cancer Center of the University of Pennsylvania.