Proton Beam Therapy (PBT) Versus Intensity-Modulated Radiation Therapy (IMRT) Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01512589
First received: January 13, 2012
Last updated: September 19, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
Radiation: Proton Beam Therapy (PBT)
Radiation: Intensity Modulated Radiation Therapy (IMRT)
Behavioral: Questionnaires
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Randomized Trial of Proton Beam Therapy Versus Intensity-Modulated Radiation Therapy for the Treatment of Esophageal Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: 6 weeks after radiation therapy ] [ Designated as safety issue: No ]
    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.

  • Total Toxicity Burden (TTB) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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).


Estimated Enrollment: 180
Study Start Date: April 2012
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proton Beam Therapy (PBT)
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)
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.
Other Names:
  • Radiation Therapy
  • XRT
Behavioral: Questionnaires
Symptom and Quality of Life questionnaires completed at baseline, every week during radiation therapy, during break after radiation therapy, and during follow up phase.
Other Name: Surveys
Active Comparator: Intensity Modulated Radiation Therapy (IMRT)
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)
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.
Other Names:
  • Radiation Therapy
  • XRT
Behavioral: Questionnaires
Symptom and Quality of Life questionnaires completed at baseline, every week during radiation therapy, during break after radiation therapy, and during follow up phase.
Other Name: Surveys

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. Potentially resectable or unresectable esophageal cancer patients
  4. Induction chemotherapy prior to concurrent chemoradiation allowed
  5. Prior Endoscopic Mucosal Resection (EMR) with a diagnosis of stage II-III esophageal cancer is eligible
  6. Performance status of Karnofsky Performance Scale (KPS) >/= 60 or Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2.
  7. Prior thoracic radiation allowable only if there is minimal to no overlap with the treatment area estimated at the time of consultation.
  8. Negative pregnancy test (serum or urine) for women of child bearing potential. All protocol participants must agree to adequate contraception.
  9. 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)
  10. Able to communicate in the English language.
  11. Any patient deemed eligible for chemoradiation for esophageal cancer treatment.

Exclusion Criteria:

  1. 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
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512589

Contacts
Contact: Steven H. Lin, MD,PHD 713-563-2300

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Steven H. Lin, MD,PHD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01512589     History of Changes
Other Study ID Numbers: 2011-1036, NCI-2012-00078
Study First Received: January 13, 2012
Last Updated: September 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
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

Additional relevant MeSH terms:
Esophageal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 23, 2014