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Esophageal CancerPhase 2ES01NCT03234842

Dose Escalated Proton Beam Therapy or Photon Therapy for Esophageal Cancer

A Phase 2 study testing Proton Beam Therapy, Photon Radiation Therapy and Chemotherapy in people with Esophageal Cancer, run by University of Florida at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study will evaluate if proton beam therapy as part of chemoradiation results in a decrease in diffusion lung capacity of carbon monoxide (DLCO) compared to photon radiation therapy for esophageal carcinoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Cancer
What is being tested?
Proton Beam Therapy, Photon Radiation Therapy and Chemotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
30 Oct 2017to 11 Dec 2018
Phase
Phase 2
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

Who may be able to join

  • Patient must be at least 18 years at the time of consent.
  • Pathologically confirmed esophageal adenocarcinoma or squamous cell. carcinoma of the thoracic esophagus or esophagogastric junction.
  • Patient's preliminary cancer stage, according to the AJCC 7th edition staging, must be cT1b-T4, N0-N3.

Who cannot join

  • Patients with cervical esophageal carcinoma.
  • Prior radiotherapy with fields overlapping the current esophageal cancer.
  • Patients with cT1a disease.
  • Patients with evidence of tracheoesophageal fistula must undergo bronchoscopy to exclude fistula.
  • Patients with distant metastatic disease.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Florida Proton Therapy Institute

    Jacksonville, Florida, 32206

Other trials in United States

About this study

Official title: A Phase II Trial of Dose Escalated Proton Beam Therapy or Photon Therapy for Resectable and Unresectable Esophageal Cancer

This study will evaluate if proton beam therapy as part of chemoradiation results in a decrease in diffusion lung capacity of carbon monoxide (DLCO) compared to photon radiation therapy for esophageal carcinoma. A secondary objective is to determine effects on cardiac function, quality of life, and compare acute and late toxicities.

Read the detailed description

Radiation Modality: Proton radiotherapy will be offered to all patients that meet trial eligibility. If patients decline proton radiotherapy or are otherwise unable to receive proton therapy they will be included in x-ray cohort (group 2).

Chemotherapy will be delivered at the discretion of the treating Medical Oncologist. Weekly carboplatin and paclitaxel at standard doses is preferred. It is recommended that the weekly chemotherapy regimen be continued throughout the course of radiotherapy. Chemotherapy should begin within 48 hours of beginning radiotherapy.

Being tested
Proton Beam Therapy, Photon Radiation Therapy, Chemotherapy
Keywords
Esophagus, Proton, Radiation
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Proton Beam TherapyRadiation

    Also called Proton Therapy

    59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses

  • Photon Radiation TherapyRadiation

    Also called IMRT

    59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses

  • ChemotherapyDrug

    Also called Carboplatin, Paclitaxel

    Concurrent weekly chemotherapy at standard doses

Study groups in NCT03234842
Study groupRoleWhat they receive
ProtonExperimentalProton beam therapy of 59.4 Gy in 1.8 Gy fractions (50.4 Gy if unable to meet cardiac/lung- organs at risk (OAR) constraints) plus concurrent standard chemotherapy
Receives: Radiation: Proton Beam Therapy; Drug: Chemotherapy
PhotonActive comparatorPhoton Radiation therapy of 59.4 Gy in 1.8Gy fractions ( 50.4 Gy if unable to meet cardiac/lung- organs at risk (OAR) constraints) plus concurrent standard chemotherapy
Receives: Radiation: Photon Radiation Therapy; Drug: Chemotherapy

What is being measured

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

  1. Compare the rate of a clinically significant reduction of DLCO (defined as a decrease of ≥ 10% from baseline) between protons and photons after preoperative or definitive chemoradiation

    Participants with a clinically significant reduction of DLCO approximately 12 months after radiation therapy

    Measured: Approximately 12 months after radiation therapy

Secondary outcomes (4)

  1. Compare quality of life

    Participants quality of life results using EORTC Quality of Life Questionnaire - Oesophageal Cancer Module (OES-18) and EORTC QLQ C-30 conjointly approximately 12 months after radiation therapy

    Measured: Approximately 12 months after radiation therapy

  2. Compare outcomes for local control

    Number of participants with local control for proton and photon radiation and concurrent chemotherapy as part of definitive therapy or trimodality therapy approximately 12 months after radiation therapy

    Measured: Approximately 12 months after radiation therapy

  3. Compare outcomes for progression free survival

    Number of participants with progression free survival for proton and photon radiation and concurrent chemotherapy as part of definitive therapy or trimodality therapy approximately 12 months after radiation therapy

    Measured: Approximately 12 months after radiation therapy

  4. Compare overall survival rates

    Number of participants with overall survival rates for proton and photon radiation and concurrent chemotherapy as part of definitive therapy or trimodality therapy approximately 12 months after radiation therapy

    Measured: Approximately 12 months after radiation therapy

Timeline

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

  1. First posted31 Jul 2017
  2. Study start30 Oct 2017
  3. Primary completion11 Dec 2018
  4. Study completion11 Dec 2018

Why it stopped: non-accrual

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03234842
Sponsor's protocol ID
UFPTI 1605-ES01
Acronym
ES01
Status last verified
Dec 2018
First submitted
21 Jul 2017
Last updated
21 Dec 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016 Jan-Feb;66(1):7-30. doi: 10.3322/caac.21332. Epub 2016 Jan 7.

    PubMed 26742998

  • Walsh TN, Noonan N, Hollywood D, Kelly A, Keeling N, Hennessy TP. A comparison of multimodal therapy and surgery for esophageal adenocarcinoma. N Engl J Med. 1996 Aug 15;335(7):462-7. doi: 10.1056/NEJM199608153350702.

    PubMed 8672151

  • van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. doi: 10.1056/NEJMoa1112088.

    PubMed 22646630

  • Tepper J, Krasna MJ, Niedzwiecki D, Hollis D, Reed CE, Goldberg R, Kiel K, Willett C, Sugarbaker D, Mayer R. Phase III trial of trimodality therapy with cisplatin, fluorouracil, radiotherapy, and surgery compared with surgery alone for esophageal cancer: CALGB 9781. J Clin Oncol. 2008 Mar 1;26(7):1086-92. doi: 10.1200/JCO.2007.12.9593.

    PubMed 18309943

  • Stahl M, Stuschke M, Lehmann N, Meyer HJ, Walz MK, Seeber S, Klump B, Budach W, Teichmann R, Schmitt M, Schmitt G, Franke C, Wilke H. Chemoradiation with and without surgery in patients with locally advanced squamous cell carcinoma of the esophagus. J Clin Oncol. 2005 Apr 1;23(10):2310-7. doi: 10.1200/JCO.2005.00.034.

    PubMed 15800321

  • Bedenne L, Michel P, Bouche O, Milan C, Mariette C, Conroy T, Pezet D, Roullet B, Seitz JF, Herr JP, Paillot B, Arveux P, Bonnetain F, Binquet C. Chemoradiation followed by surgery compared with chemoradiation alone in squamous cancer of the esophagus: FFCD 9102. J Clin Oncol. 2007 Apr 1;25(10):1160-8. doi: 10.1200/JCO.2005.04.7118.

    PubMed 17401004

  • Gergel TJ, Leichman L, Nava HR, Blumenson LE, Loewen GM, Gibbs JE, Khushalani NI, Leichman CG, Bodnar LM, Douglass HO, Smith JL, Kuettel MR, Proulx GM. Effect of concurrent radiation therapy and chemotherapy on pulmonary function in patients with esophageal cancer: dose-volume histogram analysis. Cancer J. 2002 Nov-Dec;8(6):451-60. doi: 10.1097/00130404-200211000-00009.

    PubMed 12500854

  • von Dobeln GA, Nilsson M, Adell G, Johnsen G, Hatlevoll I, Tsai J, Lundell L, Lund M, Lind P. Pulmonary function and cardiac stress test after multimodality treatment of esophageal cancer. Pract Radiat Oncol. 2016 May-Jun;6(3):e53-e59. doi: 10.1016/j.prro.2015.10.015. Epub 2015 Nov 10.

    PubMed 26725962

  • Lee HK, Vaporciyan AA, Cox JD, Tucker SL, Putnam JB Jr, Ajani JA, Liao Z, Swisher SG, Roth JA, Smythe WR, Walsh GL, Mohan R, Liu HH, Mooring D, Komaki R. Postoperative pulmonary complications after preoperative chemoradiation for esophageal carcinoma: correlation with pulmonary dose-volume histogram parameters. Int J Radiat Oncol Biol Phys. 2003 Dec 1;57(5):1317-22. doi: 10.1016/s0360-3016(03)01373-7.

    PubMed 14630268

  • Wang J, Wei C, Tucker SL, Myles B, Palmer M, Hofstetter WL, Swisher SG, Ajani JA, Cox JD, Komaki R, Liao Z, Lin SH. Predictors of postoperative complications after trimodality therapy for esophageal cancer. Int J Radiat Oncol Biol Phys. 2013 Aug 1;86(5):885-91. doi: 10.1016/j.ijrobp.2013.04.006.

    PubMed 23845841

  • Lund M, Alexandersson von Dobeln G, Nilsson M, Winter R, Lundell L, Tsai JA, Kalman S. Effects on heart function of neoadjuvant chemotherapy and chemoradiotherapy in patients with cancer in the esophagus or gastroesophageal junction - a prospective cohort pilot study within a randomized clinical trial. Radiat Oncol. 2015 Jan 13;10:16. doi: 10.1186/s13014-014-0310-7.

    PubMed 25582305

  • De Jaeger K, Seppenwoolde Y, Boersma LJ, Muller SH, Baas P, Belderbos JS, Lebesque JV. Pulmonary function following high-dose radiotherapy of non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2003 Apr 1;55(5):1331-40. doi: 10.1016/s0360-3016(02)04389-4.

    PubMed 12654445

  • Marks LB, Fan M, Clough R, Munley M, Bentel G, Coleman RE, Jaszczak R, Hollis D, Anscher M. Radiation-induced pulmonary injury: symptomatic versus subclinical endpoints. Int J Radiat Biol. 2000 Apr;76(4):469-75. doi: 10.1080/095530000138466.

    PubMed 10815626

  • Lopez Guerra JL, Gomez DR, Zhuang Y, Levy LB, Eapen G, Liu H, Mohan R, Komaki R, Cox JD, Liao Z. Changes in pulmonary function after three-dimensional conformal radiotherapy, intensity-modulated radiotherapy, or proton beam therapy for non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2012 Jul 15;83(4):e537-43. doi: 10.1016/j.ijrobp.2012.01.019. Epub 2012 Mar 13.

    PubMed 22420964

  • Miller KL, Zhou SM, Barrier RC Jr, Shafman T, Folz RJ, Clough RW, Marks LB. Long-term changes in pulmonary function tests after definitive radiotherapy for lung cancer. Int J Radiat Oncol Biol Phys. 2003 Jul 1;56(3):611-5. doi: 10.1016/s0360-3016(03)00182-2.

    PubMed 12788165

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Proton Beam Therapy, Photon Radiation Therapy and Chemotherapy in people with Esophageal Cancer, run by University of Florida 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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 21 Dec 2018. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Compare the rate of a clinically significant reduction of DLCO (defined as a decrease of ≥ 10% from baseline) between protons and photons after preoperative or definitive chemoradiation (time frame: Approximately 12 months after radiation therapy). 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 NCT03234842, which also lists 40 linked publications.

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 21 Dec 2018.

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