Pencil Beam Scanning Proton Radiotherapy for Esophageal Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/17/2018 |
| Start Date: | July 2015 |
| End Date: | May 2020 |
An Observational Study of Pencil Beam Scanning (PBS) Proton Radiotherapy (RT) as a Component of Trimodality Therapy for Esophageal Cancer
This is a prospective observational study designed to observe the toxicity and efficacy of
PBS proton RT for patients with esophageal cancer undergoing trimodality therapy. The
investigators hypothesize that PBS proton RT will be associated with a favorable adverse
event profile and quality of life, with similar disease control outcomes, relative to
historical comparisons of patients treated with photon RT.
PBS proton RT for patients with esophageal cancer undergoing trimodality therapy. The
investigators hypothesize that PBS proton RT will be associated with a favorable adverse
event profile and quality of life, with similar disease control outcomes, relative to
historical comparisons of patients treated with photon RT.
Inclusion Criteria:
- Age ≥ 18 years.
- Histological confirmation of adenocarcinoma or squamous cell carcinoma of the
esophagus (mid, distal, or GE junction)
- Stage T1N1-3M0 or T2-4N0-3M0 by American Joint Commission on Cancer (AJCC) 7th edition
- Tumor extends ≤ 5 cm into gastric cardia, based on EGD and PET/CT
- ECOG Performance Status (PS) 0-2 (Appendix I)
- Surgical consultation to confirm that patient is an appropriate candidate for
esophagectomy
- Medical oncology consultation to confirm that patient is an appropriate candidate for
chemotherapy
- Planned to receive standard of care neoadjuvant CRT, consisting of PBS proton RT (50
Gy/25 fractions) and concurrent chemotherapy (weekly carboplatin and paclitaxel),
followed by surgical resection
- Ability to complete questionnaire(s) by themselves or with assistance.
- Provide informed written consent.
- Willing to return to enrolling institution for follow-up (during the Active Monitoring
Phase of the study).
Note: During the Active Monitoring Phase of a study (i.e., active treatment and
observation), participants must be willing to return to the consenting institution for
follow-up.
- Willing to sign consent onto the Mayo Clinic Radiotherapy Patient Outcomes Registry
and Biobanking study, IRB number 15-000136
Exclusion Criteria:
- Cervical or upper esophageal tumors with any part of tumor < 24 cm from incisors
- Prior chemotherapy or RT for esophageal cancer
- History of RT to the thorax
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment
of the investigator, would make the patient inappropriate for entry into this study or
interfere significantly with the proper assessment of adverse events.
- Immunocompromised patients and patients known to be HIV positive and not currently
receiving antiretroviral therapy. NOTE: Patients known to be HIV positive, but without
clinical evidence of an immunocompromised state, are eligible for this trial.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.
- Receiving any investigational agent which would be considered as a treatment for the
primary neoplasm.
- Other active malignancy ≤ 1 year prior to registration. EXCEPTIONS: Non-melanotic skin
cancer or carcinoma-in-situ of the cervix. NOTE: If there is a history or prior
malignancy, they must not be receiving other specific treatment for their cancer.
- History of myocardial infarction ≤6 months, or congestive heart failure requiring use
of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
We found this trial at
1
site
Click here to add this to my saved trials
