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Esophageal CancerNCT02452021

Pencil Beam Scanning Proton Radiotherapy for Esophageal Cancer

An observational study of Esophageal Cancer, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Cancer
How many people
30 participants
Where
1 siteUnited States
Study dates
Jul 2015to 21 Aug 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients with non-metastatic esophageal cancer who are candidates for neoadjuvant chemoradiotherapy followed by surgery

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: 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.

Medical subject headings
Esophageal Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of CTCAE acute grade 3 or higher adverse effects possibly attributed to neoadjuvant CRT

    Measured: Within 90 days of enrollment

Secondary outcomes (7)

  1. Surgical outcomes, including the percentage of patients who undergo a margin-negative (R0) resection and the rate of pathologic complete response (pCR)

    Measured: Within 30 days following surgery

  2. Rate of postoperative complications

    Measured: Within 30 days following surgery

  3. Length of hospital stay

    Measured: Within 30 days following surgery

  4. Rate of CTCAE late grade 3 or higher adverse effects possibly attributed to therapy

    Measured: 24 months after enrollment

  5. Rate of local-regional recurrence (LRR), progression-free survival (PFS), and overall survival (OS)

    Measured: 24 months after enrollment

  6. Patient-reported quality of life using LASA-3, Mayo-10, PRO-CTCAE, and FACT-E

    Measured: 24 months after enrollment

  7. Assessment of early cardiac toxicity after CRT using cardiac MRI

    Measured: 42 days after completion of CRT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2015 (estimated)
  2. Study startJul 2015
  3. Primary completion26 May 2017
  4. Study completion21 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02452021
Sponsor's protocol ID
15-002155
Status last verified
Jul 2021
First submitted
20 May 2015
Last updated
27 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Esophageal Cancer, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of CTCAE acute grade 3 or higher adverse effects possibly attributed to neoadjuvant CRT (time frame: Within 90 days of enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02452021.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.

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