MDACC Study Summary 2003-0769

Study Summary
No. 2003-0769:.......Esophageal; Gastric......Jaffer Ajani......Gastrointestinal Medical Oncology

Study Summary Title



Study Summary Number:	2003-0769

Study Title:	A Phase II Trial of Preoperative Chemotherapy and Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Stomach and Gastroesophageal Junction

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:	Esophageal Gastric	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Every 4 weeks at least

Treatment Agents:	5-FU Folinic Acid Oxaliplatin	Home Care:	None

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Only for surgery. Length of stay is 10 days


Description/ Intervention:	The goal of this clinical research study is to learn if a combination of 5-FU, Folinic Acid and Oxaliplatin, given with radiation therapy, is effective in the treatment of gastric or gastroesophageal cancers that will be removed by surgery if possible. The safety of this combination therapy will also be studied.

Study Objectives / Outcomes

To determine the pathologic response rate. (Primary)
To assess curative resection rate, survival, and tolerance. (Secondary)
To determine the feasibility of preoperative chemoradiotherapy for patients with potentially resectable adenocarcinoma of the stomach. (Secondary)
To study, on an exploratory basis, pharmacogenomics, microarray analyses as a tool to predict for sensitivity to chemotherapy and prediction of pathologic response, and prediction of radiation sensitivity. (Secondary)

Study Status Information



Study Activation / Registration Date:	01/13/2004

IRB Review and Approval Date:	12/03/2003

Study Type:	Therapeutic

Recruitment Status:	Closed

Projected Accrual:	58

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) Patients with potentially resectable adenocarcinoma of the stomach with histologic proof of adenocarcinoma, clinically staged T2-3, any N, M0 or T1N1M0 Gastric carcinoma may involve the gastroesophageal junction, however, the bulk of the tumor must be in the stomach (defined by radiographs, endoscopy, or endoscopic ultrasonography).

2) No prior major surgery of the stomach or radiation therapy to the stomach or immunotherapy or chemotherapy.

3) Patients must have a performance status of < 2 Zubrod scale (Appendix II).

4) Patients must have adequate bone marrow function (defined as peripheral absolute granulocyte count of >1,500/�L, and platelet count of > 100,000/�L), adequate liver function (bilirubin <= 1.5 mg/dl), and adequate renal function (creatinine <= 1.5 mg/dl).

5) Pretreatment evaluations must be done per the guidelines in Section 8.0.

6) A feeding jejunostomy must be inserted in all patients.

7) Patient must sign an informed consent prior to study entry.

8) Pt must be chronologic <= 75.

Exclusion Criteria:

1) Patients with T1N0 MO or T4 carcinoma documented by endoscopic ultrasonography.

2) Positive cytology of pleural, or pericardial effusion or patients with any peritoneal disease diagnosed by laparoscopy.

3) Biopsy proof of lymph node metastases outside the study field such as supraclavicular, mediastinal, or para-aortic nodes.

4) Evidence of metastatic disease to distant organs (biopsy is suggested for questionable findings).

5) Patients with cardiac disease graded as New York Heart Association Class III or IV, severe uncontrolled diabetes, hypertension, cerebrovascular disease, or infection.

6) Patients with diabetic neuropathy.

7) Abnormalities of mental status such that either the patient cannot fully comprehend the therapeutic implications of the protocol or comply with the requirements.

8) Presence of concurrent or previous malignancies in the past 5 years (except for resected squamous or basal cell carcinoma of the skin).

9) Pregnant women are excluded from study entry due to the potential teratogenic effects of the study treatment.

Links

Registration Number: NCT00525785
Study Information on Clinical Trials Registry (clinicaltrials.gov)