N/A
N=74
A Volume, Motion, and Anatomically Adaptive Approach to Photon and Proton Beam Radiotherapy
Biopsy Proven Non Small Cell Lung Cancer · Head and Neck Cancer · Gastrointestinal Cancer · Colorectal Cancer · Rectal Cancers
Bottom Line
View on ClinicalTrials.gov: NCT02130427 ↗Enrolled (actual)
74
Serious AEs
—
Results posted
Jul 2021
Primary outcome: Primary: Tumor Volume — 93.55 cm^3
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CT scan (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tumor Volume |
93.55 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02130427). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.