NCT01512589

Brief Summary

The goal of this clinical research study is to learn how safe and effective proton-beam therapy (PBT) may be in comparison to intensity modulated radiation therapy (IMRT) in combination with chemotherapy in patients with esophageal cancer. PBT and IMRT are both forms of radiation therapy that are designed to treat a specific area of the body while affecting as little of the surrounding normal tissue as possible. PBT is a newer technology that is designed to further reduce the amount of radiation that affects the surrounding normal tissue. However, this is still being studied.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P75+ for phase_2

Timeline
12mo left

Started Apr 2012

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Apr 2012Apr 2027

First Submitted

Initial submission to the registry

January 13, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 19, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

April 30, 2012

Completed
15 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

15 years

First QC Date

January 13, 2012

Last Update Submit

April 10, 2026

Conditions

Esophageal Cancer

Keywords

Proton Beam TherapyPBTIntensity-Modulated Radiation TherapyIMRTEsophageal cancerAdenocarcinomaSquamous cell carcinomaCervical esophagusThoracic esophagusGastroesophageal junctionCardia of stomachQuestionnairesSurveysSymptom scoresQuality of lifeQOL

Outcome Measures

Primary Outcomes (2)

  • Progression-Free Survival (PFS)

    Defined from the time of enrollment to the date of death or any recurrence. The progression-free survival (PFS) time distribution will be estimated in each treatment arm using the Kaplan-Meier method.

    6 weeks after radiation therapy

  • Total Toxicity Burden (TTB)

    TTB defined from the time of randomization to 12 months after randomization. Total toxicity burden (TTB) is computed as a composite score from serious adverse events (SAEs) and, among patients who undergo surgery, postoperative complications (POCs).

    12 months

Study Arms (2)

Proton Beam Therapy (PBT)

EXPERIMENTAL

Radiation therapy 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments. 1.8 Gy (or at RBE ("Relative Biologic Equivalence" for PBT)) to be delivered to the periphery of the planning target volume (PTV).

Radiation: Proton Beam Therapy (PBT)Behavioral: Questionnaires

Intensity Modulated Radiation Therapy (IMRT)

ACTIVE COMPARATOR

Radiation therapy 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments. 1.8 Gy to be delivered to the periphery of the planning target volume (PTV).

Radiation: Intensity Modulated Radiation Therapy (IMRT)Behavioral: Questionnaires

Interventions

Proton Beam Therapy (PBT)RADIATION

1.8 Gy (Relative Biologic Equivalence ((RBE)) to be delivered to the periphery of the planning target volume (PTV) 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments.

Also known as: Radiation Therapy, XRT
Proton Beam Therapy (PBT)
Intensity Modulated Radiation Therapy (IMRT)RADIATION

1.8 Gy to be delivered to the periphery of the planning target volume (PTV) 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments.

Also known as: Radiation Therapy, XRT
Intensity Modulated Radiation Therapy (IMRT)
QuestionnairesBEHAVIORAL

Symptom and Quality of Life questionnaires completed at baseline, every week during radiation therapy, during break after radiation therapy, and during follow up phase.

Also known as: Surveys
Intensity Modulated Radiation Therapy (IMRT)Proton Beam Therapy (PBT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>/= 18
  • Histologically documented adenocarcinoma or squamous cell carcinoma of the cervical or thoracic esophagus or gastroesophageal junction or cardia of stomach.
  • Potentially resectable or unresectable esophageal cancer patients
  • Induction chemotherapy prior to concurrent chemoradiation allowed
  • Prior Endoscopic Mucosal Resection (EMR) with a diagnosis of stage II-III esophageal cancer is eligible
  • Performance status of Karnofsky Performance Scale (KPS) \>/= 60 or Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2.
  • Prior thoracic radiation allowable only if there is minimal to no overlap with the treatment area estimated at the time of consultation.
  • Negative pregnancy test (serum or urine) for women of child bearing potential. All protocol participants must agree to adequate contraception.
  • Complete blood count (CBC) and complete metabolic panel (chemo-14: Glucose, Calcium, Albumin, Total Protein, Sodium, Potassium, Carbon Dioxide (CO2), Chloride, Blood Urea Nitrogen (BUN), Creatinine, Alkaline Phosphatase, Alanine Aminotransferase (ALT) Serum Glutamic Pyruvic Transaminase (SGPT), Aspartate Aminotransferase (AST) Serum Glutamic-oxaloacetic Transaminase (SGOT), and Bilirubin) to assess adequate hematologic, renal and hepatic functioning will be obtained. The values are as follows: Adequate hematologic (White Blood Count (WBC) \>2,500/uL, platelets \> 75,000/uL), renal (Serum creatinine \</= 1.5X Upper Limit of Normal (ULN) or creatinine clearance \> 50 mL/min), and liver function (bilirubin \</=1.5 fold the upper limit of normal and liver enzymes \< 3 fold the upper limit of normal)
  • Able to communicate in the English language.
  • Any patient deemed eligible for chemoradiation for esophageal cancer treatment.

You may not qualify if:

  • Patients with active second malignancy are allowed as long as it is determined by the treating physician that the treatment of esophageal cancer is of higher priority through proper evaluation. However patients with active stage 4, metastatic cancers, receiving other systemic therapies at the time of the esophageal cancer diagnosis, will not be eligible.
  • Pregnant or breast-feeding females
  • Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to: a) active uncontrolled infection; b) Symptomatic congestive heart failure, unstable angina, or cardiac dysrrhythmia not controlled by pacer device; c) no myocardial infarction within 3 months of registration
  • Radiation treatment alone without concurrent chemotherapy or chemotherapy use alone.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Lin SH, Hobbs BP, Verma V, Tidwell RS, Smith GL, Lei X, Corsini EM, Mok I, Wei X, Yao L, Wang X, Komaki RU, Chang JY, Chun SG, Jeter MD, Swisher SG, Ajani JA, Blum-Murphy M, Vaporciyan AA, Mehran RJ, Koong AC, Gandhi SJ, Hofstetter WL, Hong TS, Delaney TF, Liao Z, Mohan R. Randomized Phase IIB Trial of Proton Beam Therapy Versus Intensity-Modulated Radiation Therapy for Locally Advanced Esophageal Cancer. J Clin Oncol. 2020 May 10;38(14):1569-1579. doi: 10.1200/JCO.19.02503. Epub 2020 Mar 11.

    PMID: 32160096DERIVED

Related Links

MeSH Terms

Conditions

Esophageal NeoplasmsAdenocarcinomaCarcinoma, Squamous Cell

Interventions

Proton TherapyRadiotherapyRadiotherapy, Intensity-ModulatedSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Heavy Ion RadiotherapyTherapeuticsRadiotherapy, ConformalRadiotherapy, Computer-AssistedData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Steven H. Lin, MD,PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2012

First Posted

January 19, 2012

Study Start

April 30, 2012

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations

US(1)