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Phase III Randomized Trial of Proton Beam Therapy Versus Intensity-Modulated Radiation Therapy for the Treatment of Esophageal Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Esophageal Cancer

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Trial Information

Phase III Randomized Trial of Proton Beam Therapy Versus Intensity-Modulated Radiation Therapy for the Treatment of Esophageal Cancer


Study Treatment:

If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the flip of a coin) to 1 of 2 study groups:

- If you are in Group 1, you will receive IMRT.

- If you are in Group 2, you will receive PBT.

You will receive radiation therapy 1 time each day, 5 days a week (Monday through Friday)
for up to 28 treatments.

Your doctor may think it is in your best interest to also receive chemotherapy (such as
investigational therapy or the combination of docetaxel and 5-fluorouracil) while you are
receiving radiation therapy. If this occurs, you will sign a separate consent form for
these drugs with a full description of how they are given and the risks they may cause.

Study Visits:

Before you begin receiving radiation therapy, you will have a baseline visit. The following
tests and procedures will be performed:

- Blood (about 1-2 tablespoons) will be drawn for routine tests.

- Your performance status will be recorded.

- You will have a PET/CT or CT scan to check the status of the disease.

- You will have lung function tests

- You will complete the symptom and quality of life questionnaires.

- Your esophagus will be examined using an endoscope. If the doctor thinks it is needed,
you will have a biopsy to check the status of the disease.

You will then have a study visit every week while you are receiving radiation therapy. The
following tests and procedures will be performed:

- Your medical history will be recorded.

- You will have a physical exam.

- Your performance status, weight, and vital signs will be recorded.

- Blood (about 1-2 tablespoons) will be drawn for routine tests.

- You will complete the symptom and quality of life questionnaires.

Length of Study:

You will receive radiation therapy for up to 28 treatments (about 5½ weeks). You will no
longer be able to receive radiation therapy if the disease gets worse, if intolerable side
effects occur, or if you are unable to follow study directions.

Your participation on the study will be over once you have completed the follow-up visits.

Follow-Up:

After you stop receiving radiation therapy, there will be a 4-6 week break. During this
time, you will contacted 2 times each week to complete the symptom and quality of life
questionnaires. You will receive a call from an automated calling service or from the study
staff at a scheduled time of your choosing.

About 4-6 weeks after you stop receiving radiation therapy, the following tests and
procedures will be performed:

- Your medical history will be recorded.

- You will have a physical exam.

- Your performance status, weight, and vital signs will be recorded.

- You will have a PET/CT scan to check the status of the disease.

- You will have lung function tests.

- Blood (about 1-2 tablespoons) will be drawn for routine tests.

- You will complete the symptom and quality of life questionnaires.

- Your esophagus will be examined using an endoscope. If the doctor thinks it is needed,
you will have a biopsy to check the status of the disease.

If your doctor thinks it is in your best interest after you have completed radiation
therapy, you will have surgery to remove the tumor. You will sign a separate consent form
that describes the procedure and its risks. As part of this study, the study doctor will
check you for side effects and discomfort after the surgery.

Every 3-4 months for 2 years, and then every 4-6 months for the next 3 years, you will have
follow-up visits. The following tests and procedures will be performed:

- Your medical history will be recorded.

- You will have a physical exam.

- Your performance status, weight, and vital signs will be recorded.

- You will have either a CT or a PET/CT scan to check the status of the disease.

- You will complete the symptom and quality of life questionnaires.

Additionally, the following tests and procedures will be performed at follow-up visits only
when the doctor thinks they are needed:

- Blood (about 1-2 tablespoons) may be drawn for routine tests.

- You may have lung function tests.

- Your esophagus will be examined using an endoscope. If the doctor thinks it is needed,
you will have a biopsy to check the status of the disease.

You may be contacted by the study staff to ask about your health, even if you choose not to
return to MD Anderson for follow-up visits after completing treatment for esophageal cancer.

This is an investigational study. IMRT and PBT are delivered using FDA-approved and
commercially available methods. It is investigational to compare IMRT to PBT.

Up to 180 patients will take part in this study. All will be enrolled at MD Anderson.


Inclusion Criteria:



1. Age >/= 18

2. Histologically documented adenocarcinoma or squamous cell carcinoma of the cervical
or thoracic esophagus or gastroesophageal junction or cardia of stomach.

3. The esophageal cancer has been staged by PET/CT and
Esophagogastroduodenoscopy/Endoscopic Ultrasound (EGD/EUS) to have stage II-III
disease

4. Potentially resectable or unresectable esophageal cancer patients

5. Must have financial coverage for proton therapy before randomization.

6. Induction chemotherapy prior to concurrent chemoradiation allowed

7. Prior Endoscopic Mucosal Resection (EMR) with a diagnosis of stage II-III esophageal
cancer is eligible

8. Performance status of Karnofsky Performance Scale (KPS) >/= 60 or Eastern Cooperative
Oncology Group (ECOG) = 0, 1, or 2.

9. Prior thoracic radiation allowable only if there is minimal to no overlap with the
treatment area estimated at the time of consultation.

10. Negative pregnancy test for women of child bearing potential. All protocol
participants must agree to adequate contraception.

11. 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 creatinine clearance > 50 mL/min), and liver function (bilirubin upper limit of normal and liver enzymes < 3 fold the upper limit of normal)

12. Able to communicate in the English language.

Exclusion Criteria:

1. Previous or concomitant cancers within the past 3 years other than curatively treated
carcinoma in situ of cervix, basal cell carcinoma of the skin, curative treatment for
transitional cell carcinoma of the bladder, and low risk prostate cancer. Except for
prostate cancer (which can be observed if low risk), other cancers listed above must
have been treated in the past 3 years without evidence of recurrence at the time of
registration.

2. Pregnant or breast-feeding females

3. 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

4. Radiation treatment alone without concurrent chemotherapy or chemotherapy use alone.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival (PFS)

Outcome Description:

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. The percent pathological complete response (CR) rate will be recorded in each arm, and the probability of pathological CR as a function of treatment arm and covariates will be assessed by logistic regression.

Outcome Time Frame:

6 weeks after radiation therapy

Safety Issue:

Yes

Principal Investigator

Steven H. Lin, MD,PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2011-1036

NCT ID:

NCT01512589

Start Date:

April 2012

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • Proton Beam Therapy
  • PBT
  • Intensity-Modulated Radiation Therapy
  • IMRT
  • Esophageal cancer
  • Adenocarcinoma
  • Squamous cell carcinoma
  • Cervical esophagus
  • Thoracic esophagus
  • Gastroesophageal junction
  • Cardia of stomach
  • Questionnaires
  • Surveys
  • Symptom scores
  • Quality of life
  • QOL
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030