MDACC Study Summary RTOG 0246

Study Summary
No. RTOG 0246:.......Esophageal......Stephen G. Swisher......Thoracic & Cardiovascular

Study Summary Title



Study Summary Number:	RTOG 0246

Study Title:	A Phase II Study of Paclitaxel-Based Chemoradiotherapy Regimen with Selective Surgical Salvage for Resectable Locoregionally Advanced Carcinoma of the Esophagus

Physician

New Patient Referral



Name:	Stephen G. Swisher	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

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

Phone:	713-792-8659 Contact us about clinical trials

General Information



Disease Group:	Esophageal	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Within 8 weeks of completion, every 3 months x 2 from end of treatment , every six months x2 then annually after.

Treatment Agents:	5-FU Cisplatin G-CSF Paclitaxel	Home Care:	None

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	Not applicable

Description/
Intervention:

The goal of this clinical research study is to find out what effects
chemotherapy (paclitaxel, cisplatin, and 5-FU) given before radiation therapy
and then given with concurrent chemotherapy and radiation therapy may have on
esophageal cancer. Researchers will also study whether certain patients can be
treated with chemotherapy without the need for surgical resection (removal of
all or part of your esophagus). This research is being done to determine
whether this is a safe and effective way of treating esophageal cancer

Study Objectives / Outcomes

Determine feasibility and ability to accrue to a non-operative approach with definitive chemotherapy, concurrent chemoradiation, and selective surgical salvage. Determine standard criteria for salvage therapy with CT scans (mandatory), serial endoscopy and ultrasound and serial PET scans (optional but encouraged). Estimate the overall survival of this selective surgical strategy: other efficacy outcomes, such as disease-free survival, also will be estimated. Assess the tolerance in patients receiving selective surgical salvage. Collect tissue specimens for the future purpose of associating molecular markers with response and treatment efficacy outcomes.

Study Status Information



Study Activation / Registration Date:	02/19/2004

IRB Review and Approval Date:	12/17/2003

Study Type:	Therapeutic

Recruitment Status:	Closed

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) Patient must have biopsy-proven resectable primary (non-recurrent) sqaumous cell of adenocarcinoma of the esophagus or GE junction. Abnormalities on PET scans. CT of chest and abdomen. EUS tumor stage must be > T1N0. Bronchospcopy is required. Zubrod PS 0-1. AGC must be >/= 150, 000/mm3, Hgb >/=10gm%, creatinine </= 1.5, or calculated creatinine clearance >/= 65 cc/min, serum calcium </= 11mg/dl. Palpable supraclavicular nodes must be proven negative for cancer. Patient >/= 18 years of age. Signed informed consent prior to study.

Exclusion Criteria:

1) Prior radiotherapy chest/abdomen, chemotherapy within the past 5 years & esophageal or gastric surgery. Patients with tumor extension beyond 2 cm in the stomach.Patients with multiple primary carcinomas of esophagus. Patients withcervical esophageal cancer. Patients with dessiminated cancer. T-E fistula. Celiac adenopathy. Patients with uncontrolled diabetes, heart disease, or hypertension. Patients who are not compliant. Pt. with hypersentivity to E-coli delivered products. Pt. receiving photdynamic therapy or other investigational agents for esophageal cancer. Pregnant ot lactating women.

Links

Registration Number: NCT00069953
Study Information on Clinical Trials Registry (clinicaltrials.gov)