Health TrialsbyHealthPanel

Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer

ConditionsClinical Stage I Esophageal Adenocarcinoma AJCC v8Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage II Esophageal Adenocarcinoma AJCC v8Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage III Esophageal Adenocarcinoma AJCC v8Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8Clinical Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8Thoracic Esophagus Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNRG Oncology

About this trial

This trial studies how well proton beam radiation therapy compared with intensity modulated photon radiotherapy works in treating patients with stage I-IVA esophageal cancer. Proton beam radiation therapy uses a beam of protons (rather than x-rays) to send radiation inside the body to the tumor without damaging much of the healthy tissue around it. Intensity modulated photon radiotherapy uses high-energy x-rays to deliver radiation directly to the tumor without damaging much of the healthy tissue around it. It is not yet known whether proton beam therapy or intensity modulated photon radiotherapy will work better in treating patients with esophageal cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically proven diagnosis of adenocarcinoma or squamous cell carcinoma of the thoracic esophagus or gastroesophageal junction (Siewert I-II)

History/physical examination

Whole-body fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) with or without contrast (preferred) or chest/abdominal (include pelvic if clinically indicated) CT with contrast

For patients who DID NOT receive induction chemotherapy, scan must occur within 30 days prior to Step 1 registration

Disqualifiers

Cervical esophageal cancers arisen from 15-18 cm from the incisors

Patients with T4b disease according to the AJCC 8th edition

Definitive clinical or radiologic evidence of metastatic disease

Any active malignancy within 2 years of study registration that may alter the course of esophageal cancer treatment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Capecitabine

    Drug

    Oral

  • Carboplatin

    Drug

    Given IV

  • Computed Tomography

    Procedure/Surgery

    Undergo CT or PET/CT

  • Docetaxel

    Drug

    IV

  • Esophagectomy

    Procedure/Surgery

    Undergo esophagectomy

  • Fluorouracil

    Drug

    IV

  • Intensity-Modulated Radiation Therapy

    Radiation

    Undergo IMRT

  • Leucovorin Calcium

    Drug

    Oral

  • Oxaliplatin

    Drug

    IV

  • Paclitaxel

    Drug

    Given IV

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Proton Beam Radiation Therapy

    Radiation

    Undergo PBT

  • Quality-of-Life Assessment

    Other intervention

    Ancillary studies

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Group I (PBT, concurrent chemotherapy, esophagectomy)Experimental treatment 14 interventions
Group B: Group II (IMRT, concurrent chemotherapy, esophagectomy)Active comparator 14 interventions

Trial outcomes

Primary outcomes

1

Overall survival (OS)

Will be estimated by the Kaplan-Meier method. The distributions of OS between treatment arms will be compared using the log rank test.

Time frame
From the date of randomization to the date of death due to any cause or date of last follow-up for patients without an OS event reported. This analysis occurs after 173 deaths; estimated to occur 4 years after accrual completion
2

Incidence of specific grade 3+ cardiopulmonary adverse events (AEs) that are definitely, probably, or possibly related to protocol treatment

Will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Difference in proportion of defined cardiopulmonary AEs will be analyzed with a chi-squared test.

Time frame
From baseline up to 8 years

Secondary outcomes

1

Change in patient reported outcomes (PROs) of symptom and function

Will be assessed using the MD Anderson Symptom Inventory (MDASI) and the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue tools. The primary analysis cohorts for PRO endpoints will be intent-to-treat, with sensitivity analyses done limited to patients that started protocol treatment. General linear models with maximum likelihood estimation will be used to assess MDASI symptom severity and functioning trends across time as the primary PRO endpoints. Mean change (follow-up time point - baseline score) in fatigue will be compared between treatment arms using a t-test. If the data do not satisfy the normality assumption, a Wilcoxin test may be used instead. Additionally, a general linear model with maximum likelihood estimation will be used to assess fatigue trends across time.

Time frame
Baseline up to 12 months after end of chemoradiation
2

Pathologic response rate

A Chi-square test will be used to compare the pathologic response rates between the treatment arms.

Time frame
At time of surgery
3

Length of hospitalization

Will be defined as number of days in the hospital post protocol-defined surgery. Mean hospitalization days will be compared between treatment arms using a t-test. If the data do not satisfy the normality assumption, a Wilcoxin test may be used instead.

Time frame
From baseline up to 8 years
4

Grade 4 lymphopenia during chemoradiation

Will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. The proportion of patients experiencing grade 4 lymphopenia during chemoradiation will be compared between treatment arms using a chi-squared test.

Time frame
From baseline up to 8 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NRG Oncology

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
Apply now