MDACC Study Summary 2004-0703 (Archived)

Study Summary
No. 2004-0703:.......Esophageal; Gastrointestinal......Jaffer Ajani......Gastrointestinal Medical Oncology

Study Summary Title



Study Summary Number:	2004-0703

Study Title:	AN OXALIPLATIN-BASED PHASE II RANDOMIZED STUDY OF INDUCTION CHEMOTHERAPY FOLLOWED BY PREOPERATIVE CHEMORADIOTHERAPY OR PREOPERATIVE CHEMORADIOTHERAPY IN PATIENTS WITH RESECTABLE ESOPHAGEAL OR GASTROESOPHAGEAL CARCINOMA

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 Gastrointestinal	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Twice a month

Treatment Agents:	5-Fluorouracil Oxaliplatin	Home Care:	None

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	None


Description/ Intervention:	The goal of this clinical research study is to learn if a combination of the investigational drug oxaliplatin with 5-FU (given at the same time as radiation therapy) is as effective as a combination of these two drugs given before and during radiation therapy in the treatment of esophageal or gastroesophageal cancers. The safety of these combinations of therapy will also be compared.

Study Objectives / Outcomes

Primary objective:

Compare the Pathologic Complete Response rate and % of patients with <50% residual cancer in the resected surgical specimen between Arms A and B.

Secondary objectives:

1. Compare 1-year and 3-year survival rates, median survival time, R0 resection rates, safety, and local plus systemic relapse rates between Arms A and B
2. Perform exploratory correlative studies on blood, adjacent normal and cancer tissue to assess predictive markers of response and outcome.
3. Evaluate the joint effects, including possible interactive effects, of proton-versus-photon therapy and treatment arm on overall survival, R0 resection rates, safety, and local plus systemic relapse rates.

Study Status Information



Study Activation / Registration Date:	02/10/2005

IRB Review and Approval Date:	01/18/2005

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Terminated

Projected Accrual:	N/A

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) Local regional carcinoma of the thoracic esophagus (squamous cell or adeno) or gastroesophageal junction.

2) Patients with T1N1, and T2-3 with any N (M1a only) will be eligible.

3) Normal liver(SGPT < 56�L, Total Bilirubin <1.5 mg/dL), kidney(Creatinine <1.75 mg/dL), and bone marrow functions(AGN >1,500�L, platelet count >100,000/�L).

4) Performance status 0 or 1.

5) Signed informed consent by the investigator or their designee and patient.

6) Medically fit for surgery.

7) No Celiac (except for the GE junction cancers), supraclavicular, or paraaortic nodal enlargement unless biopsy negative.

8) None of the celiac nodes should be larger than 2 cm

9) Male or Female but both sexes must practice adequate contraception while on therapy

10) >/=18 years but less than 76 years

11) No known allergy to any of the study drugs.

12) No prior therapy for this cancer.

13) No significant cancer (defined as non-melanomatous skin cancers and treated cervical cancers) within the past 5 years

14) NYHA I and II

Exclusion Criteria:

1) Patients with T1N0, T4, or M1b cancer will be excluded

2) Significant comorbid conditions (defined as uncontrolled diabetes, active angina or heart failure, uncontrolled hypertension, or active psychiatric condition that prevents consistent participation and compliance).

3) More than grade 1 neuropathy

4) Unable to comprehend the requirements of the study or comply with it.

Links

Registration Number: NCT00525915
Study Information on Clinical Trials Registry (clinicaltrials.gov)