Simultaneous Integrated Boost (SIB) in Esophageal Cancer
This study is currently recruiting participants.
Verified April 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01102088
First received: April 9, 2010
Last updated: April 2, 2013
Last verified: April 2013
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Purpose
The goal of this clinical research study is to find the highest tolerable dose of radiation that can be given in combination with docetaxel and 5-fluorouracil (5-FU) or Xeloda (capecitabine) in patients with esophageal cancer that cannot be removed by surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer |
Drug: 5-Fluorouracil Drug: Docetaxel 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) [ Time Frame: 6 Weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 42 |
| Study Start Date: | April 2010 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 5-Fluorouracil, Docetaxel + Radiation
Chemotherapy infusions of docetaxel + 5-fluorouracil during each radiation therapy week for 5 weeks. 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. |
Drug: 5-Fluorouracil
Chemotherapy infusions of docetaxel + 5-fluorouracil during each radiation therapy week for 5 weeks.
Other Names:
Drug: Docetaxel
Chemotherapy infusions of docetaxel and 5-fluorouracil during each radiation therapy week for 5 weeks.
Other Name: Taxotere
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:
- Histologically confirmed primary (non-recurrent) adenocarcinoma (AC) or squamous cell carcinoma of the esophagus or AC of the gastroesophageal (GE) junction.
- Age >/= 18.
- 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.
- Patients with distant metastasis and life expectancy >/= 3 months are eligible.
- ECOG Performance Status 0-2
- No prior radiation to the thorax that would overlap with the current treatment field, prior radiation to other areas is allowed.
- Patients with nodal involvement are eligible
- 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
- 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.
- Patients (men and women) of childbearing potential must use effective method of birth control throughout their participation in this study.
- Induction chemotherapy is allowed.
Exclusion Criteria:
- Patients with T1, N0 lesions.
- 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.
- Prior surgery or radiotherapy for esophageal or gastroesophageal junction cancer.
- Prior radiotherapy that would overlap the anticipated study treatment fields.
- 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.
- 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.
- Known hypersensitivity to docetaxel, 5-FU.
- 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
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 |
| Study First Received: | April 9, 2010 |
| Last Updated: | April 2, 2013 |
| 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 Diseases Esophageal Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Fluorouracil |
Docetaxel Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013