Simultaneous Integrated Boost (SIB) in Esophageal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01102088
First received: April 9, 2010
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

The goal of this clinical research study is to find the highest tolerable dose of radiation that can be given in combination with chemotherapy in patients with esophageal cancer that cannot be removed by surgery.


Condition Intervention Phase
Esophageal Cancer
Radiation: Radiation Therapy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Evaluating the Safety of Using a Simultaneous Integrated Boost for Dose Escalation in Patients With Esophageal Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) of Simultaneous Integrated Boost (SIB) [ Time Frame: 8 Weeks ] [ Designated as safety issue: Yes ]
    The maximum tolerated dose is defined as the highest dose for which the probability of toxicity is closest to 30%. The dose limiting toxicity (DLT) is defined as CTCAE 3.0 grade 3 or 4 esophagitis within 8 weeks after completion of radiation therapy.


Estimated Enrollment: 42
Study Start Date: April 2010
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiation + Chemotherapy

Simultaneous integrated boost (SIB) used in combination with a fixed dose of radiation (180 cGy in 28 fractions = 5040 Gy PTV dose). Two dose levels (210 cGy and 225 cGy each in 28 fractions) of SIB will be considered in the phase I part of the study, starting at 210 cGy in 28 daily fractions.

Chemotherapy Administration: Schedule of chemotherapy, and modifications of chemotherapy drugs during chemoradiation treatment will be at the discretion of the treating medical oncologist per their standard of practice and with consideration to standard chemotherapy drugs in the treatment of esophageal cancer.

Radiation: Radiation Therapy
Simultaneous integrated boost (SIB) used in combination with a fixed dose of radiation (180 cGy in 28 fractions = 5040 Gy PTV dose). Two dose levels (210 cGy and 225 cGy each in 28 fractions) of SIB will be considered in the phase I part of the study, starting at 210 cGy in 28 daily fractions.

  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. Histologically confirmed primary (non-recurrent) adenocarcinoma (AC) or squamous cell carcinoma of the esophagus or AC of the gastroesophageal (GE) junction.
  2. Age >/= 18.
  3. Patients must be deemed unresectable disease or considered for a selective surgical approach (where surgery is delay if a patient achieves a complete response) as determined by the multidisciplinary evaluation or patient is not considered operable due to medical reasons.
  4. Patients with distant metastasis and life expectancy >/= 3 months are eligible.
  5. ECOG Performance Status 0-2
  6. No prior radiation to the thorax that would overlap with the current treatment field, prior radiation to other areas is allowed.
  7. Patients with nodal involvement are eligible
  8. Adequate bone marrow, and renal functions as assessed by the following: Hemoglobin >/= 9.0 g/dl, Platelet count >/= 100,000/mm^3, Creatinine </=1.5 times ULN
  9. Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.
  10. Patients (men and women) of childbearing potential must use effective method of birth control throughout their participation in this study.
  11. Induction chemotherapy is allowed.

Exclusion Criteria:

  1. Patients with T1, N0 lesions.
  2. Patients with a TE fistula or direct invasion into the mucosa of the trachea or major bronchi. Bronchoscopy is encouraged if a TE fistula is suspected. The presence of a fistula will exclude a patient from this study.
  3. Prior surgery or radiotherapy for esophageal or gastroesophageal junction cancer.
  4. Prior radiotherapy that would overlap the anticipated study treatment fields.
  5. Patients with active second malignancy are allowed as long as it is determined that the treatment of esophageal cancer is a higher priority through proper subspecialty consultations.
  6. Uncontrolled concurrent illness including, but not limited to: serious uncontrolled infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with the study requirements.
  7. Known hypersensitivity to docetaxel, 5-FU.
  8. Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study.
  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: NCT01102088

Contacts
Contact: James Welsh, MD 713-563-2300

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: James Welsh, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: James Welsh, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01102088     History of Changes
Other Study ID Numbers: 2009-0847, NCI-2011-02030
Study First Received: April 9, 2010
Last Updated: July 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Cancer
Gastroesophageal
Simultaneous Integrated Boost
SIB
5-Fluorouracil
5-FU
Adrucil
Efudex
Docetaxel
Taxotere
Radiation
chemoradiation

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

ClinicalTrials.gov processed this record on September 18, 2014