E8296 – Trial Results Summary for Patients

Title

Combination Chemotherapy after Surgery to Treat Patients with Cancer of the Esophagus (A Phase II Trial)

Sponsor

Eastern Cooperative Oncology Group through the NCI-sponsored Cancer Cooperative Group Program

Purpose of the Study

The purpose of this study was to see if chemotherapy treatment, using a combination of the drugs, paclitaxel and cisplatin, following surgery would improve survival rates for patients with cancer of the esophagus.

Results

The results of the study suggest that treating patients with a combination of paclitaxel and cisplatin after surgery may improve survival in patients whose esophageal cancer was completely removed and had involvement of regional lymph nodes. Two years after the study, 60 percent of the participating patients were alive. Three-year survival was 42 percent. Median survival (the time at which half the patients in the study are still alive) was 2.6 years. These results suggest an improvement in survival compared with surgery alone in which the two-year survival is 30 percent.

Conclusion

The role of adjuvant chemotherapy in esophageal cancer management requires further investigation. No prospective randomized comparative trials are planned at this time. The specific adjuvant treatment evaluated in this phase II trial should be considered investigational.

Start Date

March 1998

Stop Date

March 2000

Number of Participating Patients

59

Eligibility Requirements

Patients were over 18 years old and had cancer of the esophagus. They had surgery to remove the tumor four to twelve weeks before starting the study treatment. They had no previous chemotherapy or radiation treatment. The cancer involved lymph nodes, but had not spread to other parts of the body.

Study Design

Patients had surgery to remove their tumor 4-12 weeks before the start of the trial. Treatment was designed in three-week cycles. Patients received a combination of chemotherapy drugs (paclitaxel and cisplatin) in a vein over a three-hour period. This treatment was repeated every 21 days for four cycles. Participants received follow-up evaluations every three months for two years, every six months for the next three years, and every 12 months thereafter.

Side Effects

Lowered blood counts were experienced by 22 percent of study participants. Nausea and vomiting (8.5 percent) and problems with metabolism (8.5 percent) were the other most common side effects.

Additional Information at ClinicalTrials.gov

NCT00003237