MDACC Study Summary 2008-0752

Study Summary
No. 2008-0752:.......Gastrointestinal......Jaffer Ajani......Gastrointestinal Medical Oncology

Study Summary Title



Study Summary Number:	2008-0752

Study Title:	FDG-PET-CT and Biomarkers to Assess Pathologic Response in Surgical Specimens of Patients with Localized Esophageal Cancer after Chemoradiation

Physician

New Patient Referral



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

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

Phone:	713-792-2828 Contact us about clinical trials

General Information



Disease Group:	Gastrointestinal	Supported By:	MDACC Institute for Personalized Cancer Therapy NCI

Phase of Study:	N/A	Return Visit:	Participation in this study will involve 1 or 2 additional visits to MDACC.

Treatment Agents:	Biopsy EGD (Esophagastroduodenoscopy) PET/CT (Positive Emission Tomography/Computerized Tomography)	Home Care:	Not applicable. Study procedures must be performed at M. D. Anderson

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Hospitalization is not required.

Description/
Intervention:

The goal of this clinical research study is to learn if the results of a
positron emission tomography/computed tomography (PET/CT) scan done 10-14 days
after beginning chemotherapy and radiation (chemoradiation) can predict how a
patient with cancer of the esophagus will respond to chemoradiation.
Researchers also want to learn if biomarkers (substances in the body associated
with cancer) found in tumor tissue can predict response to chemoradiation.

Study Objectives / Outcomes

Primary

Determine if the changes in PET-CT maximum standardized unit value (SUV) (from baseline PET-CT to "early" PET-CT [12 + 2 days after the start of chemoradiation]) are predictive of pathologic complete response (pathCR) and/or extreme chemoradiation resistance (exCRTR) in 90 prospectively accrued patients with esophageal cancer who will undergo chemoradiation and surgery.

Secondary

Establish the predictive accuracy of pre-treatment nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB), glioma-associated oncogene homolog 1(Gli-1), and sonic hedgehog homolog (SHH) signature for pathCR and/or exCRTR in 90 prospectively accrued patients with esophageal cancer who will undergo chemoradiation and surgery.
Determine if a robust model for prediction of pathCR and/or exCRTR can be established by combining the biomarker signature and PET-CT signature.
(Exploratory): To measure the changes in biomarkers (pre-treatment, and early [12 ą 2 days]) and to assess its correlation with PET-CT changes and pathologic response (pathCR and/or exCRTR) in 30 patients who will undergo chemoradiation followed by surgery.

Study Status Information



Study Activation / Registration Date:	02/25/2009

IRB Review and Approval Date:	02/25/2009

Study Type:	Other

Recruitment Status:	Open

Projected Accrual:	95

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) Patient must have histologic documentation of adenocarcinoma or squamous carcinoma of the esophagus at M. D. Anderson Cancer Center (MDACC).

2) Patients with localized carcinoma of the esophagus who have undergone standard testing and been evaluated by the multidisciplinary team at MDACC and are considered appropriate candidates for and are willing to undergo chemoradiation therapy followed by surgery at MDACC. Radiation may be delivered as proton or photon. These patients have clinical stage II or III cancers and they are considered medically fit to undergo surgery.

3) Patient must have undergone a baseline esophagealgastroduodenoscopy (EGD) with biopsy and endoscopic ultrasonography at MDACC, with tissue available for biomarker analysis.

4) Patient must have undergone a baseline FDG-PET/CT at MDACC or an outside institution.

5) Patient must be willing to undergo a research "early" FDG-PET/CT (12 +/- 2 days from the start of chemoradiation).

6) Patient must provide written informed consent.

7) Patient must be >/= 18 years of age.

Exclusion Criteria:

1) Patient is unable or unwilling to comply with the requirements of the protocol.

2) Patient had baseline FDG-PET/CT scan maximum SUV of < 4.0.

3) Patient is not a candidate for chemoradiation followed by surgery.

4) Patients who received induction chemotherapy prior to chemoradiation therapy are excluded.

5) Patients with T1N0 or T4anyN are excluded.

Links

Registration Number: NCT00833625
Study Information on Clinical Trials Registry (clinicaltrials.gov)