MDACC Study Summary 2009-0847

Study Summary
No. 2009-0847:.......Esophagus......James Welsh......Radiation Oncology

Study Summary Title



Study Summary Number:	2009-0847

Study Title:	Phase I/II Study of Evaluating the Safety and Efficacy of Using a Simultaneous Integrated Boost for Dose Escalation in Patients with Esophageal Cancer

Physician

New Patient Referral



Name:	James Welsh	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Radiation Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-2300 Contact us about clinical trials

General Information



Disease Group:	Esophagus	Supported By:	N/A

Phase of Study:	Phase I/Phase II	Return Visit:	Patients will be assessed weekly during radiation therapy and 2 weeks after radiation therapy and 6-8 weeks after completion of chemoradiation.

Treatment Agents:	5-Fluorouracil Docetaxel Radiation	Home Care:	n/a

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	n/a


Description/ Intervention:	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.

Study Objectives / Outcomes

Primary Objectives:

To determine the maximal tolerated dose (MTD) of chemoradiation using a simultaneous integrated boost to dose escalate the gross tumor volume, in patients with esophageal cancer. The MTD is defined as highest level of Common Terminology Criteria for Adverse Events (CTCAE) v3 grade 3 acute radiation toxicity of esophagitis either during treatment or up to 2 weeks after completion of radiation therapy. The maximum acceptable toxicity rate for this study will be is 30%. This rate was based on what we would consider as acceptable based on out prior rate of grade 3 esophagitis rate seen in the last 3 years at MD Anderson of 16%. This compares favorable compared to the historic rates of other institutions such as the CALGB 9781 which has a 27% rate. We assume the prior distribution of the toxicity rate is beta (0.5, 0.5).

Secondary Objectives:

· To evaluate whether using a simultaneous integrated boost to dose escalate the gross tumor volume, in patients with esophageal cancer can improve tumor response (CR+PR) rate, as defined by EUS and or positron emission tomography (PET) scan.
· Evaluate for tissue biomarkers which may be used to predict local versus distant failures.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	04/07/2010

Study Type:	Phase I

Recruitment Status:	Open

Projected Accrual:	42

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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.

Links

Registration Number: NCT01102088
Study Information on Clinical Trials Registry (clinicaltrials.gov)