Randomized Phase II Study of Preoperative Combined Modality Paclitaxel / Cisplatin / RT or Irinotecan / Cisplatin / RT Followed by Postoperative Chemotherapy With the Same Agents in Operable Adenocarcinoma of the Esophagus
- Compare the pathologic complete response rate in patients with adenocarcinoma of the
esophagus or gastroesophageal junction treated with radiotherapy with pre- and
post-operative cisplatin plus paclitaxel versus cisplatin plus irinotecan.
- Compare the survival outcome in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the tolerability of these adjuvant chemotherapy regimens after neoadjuvant
chemoradiotherapy in these patients.
- Compare time to progression or recurrence in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG
performance status (0 vs. 1) and stage of disease (T2-3, N0, M0 vs. T1-3, N0-1, M0 or M1A).
Patients are randomized to 1 of 2 treatment arms.
- Arm A: Patients receive neoadjuvant radiotherapy once daily, 5 days a week, for 5 weeks
beginning on day 1 concurrently with neoadjuvant chemotherapy comprising cisplatin IV
(Intravenous) over 2-3 hours followed by irinotecan IV over 30-60 minutes once daily on
days 1, 8, 22, and 29. Four to six weeks after completion of neoadjuvant
chemoradiotherapy, patients undergo surgical resection. A minimum of 4 weeks after
resection, patients receive adjuvant chemotherapy comprising cisplatin and irinotecan
as above on days 1 and 8. Treatment with adjuvant chemotherapy repeats every 3 weeks
for 3 courses.
- Arm B: Patients receive neoadjuvant radiotherapy as in arm A concurrently with
neoadjuvant chemotherapy comprising paclitaxel IV (Intravenous) over 1 hour followed by
cisplatin IV over 2-3 hours once daily on days 1, 8, 15, 22, and 29. Patients then
undergo surgical resection as in arm A. A minimum of 4 weeks after resection, patients
receive adjuvant chemotherapy comprising paclitaxel IV over 3 hours followed by
cisplatin as above on day 1. Treatment with adjuvant chemotherapy repeats every 3 weeks
for 3 courses.
In both arms, treatment continues in the absence of disease progression or unacceptable
Patients are followed at 1 month, every 3 months for 2 years, every 6 months for 3 years,
and then annually for 5 years.
ACCRUAL: A total of 97 patients (50 on Arm A and 47 on Arm B) were accrued for this study.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathologic Complete Response Rate
A patient would have achieved a pathologic complete response if no histopathological evidence of residual tumor is found in the resected esophageal specimen and nodal tissue.
approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry
Larry Kleinberg, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|
|CCOP - Christiana Care Health Services||Wilmington, Delaware 19899|
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|CCOP - Iowa Oncology Research Association||Des Moines, Iowa 50309-1016|
|CCOP - Metro-Minnesota||Saint Louis Park, Minnesota 55416|
|CCOP - Michigan Cancer Research Consortium||Ann Arbor, Michigan 48106|
|CCOP - Sioux Community Cancer Consortium||Sioux Falls, South Dakota 57105-1080|
|CCOP - MainLine Health||Wynnewood, Pennsylvania 19096|
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|
|MetroHealth's Cancer Care Center at MetroHealth Medical Center||Cleveland, Ohio 44106|
|CCOP - Scott and White Hospital||Temple, Texas 76508|
|Veterans Affairs Medical Center - Lakeside Chicago||Chicago, Illinois 60611|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|CCOP - St. Vincent Hospital Cancer Center, Green Bay||Green Bay, Wisconsin 54301|
|CCOP - Colorado Cancer Research Program, Incorporated||Denver, Colorado 80224|
|CCOP - Toledo Community Hospital||Toledo, Ohio 43623-3456|
|CCOP - Marshfield Clinic Research Foundation||Marshfield, Wisconsin 54449|
|Shands Cancer Center at the University of Florida Health Science Center||Gainesville, Florida 32610-0296|
|Cancer Institute of New Jersey at Robert Wood Johnson University Hospital||New Brunswick, New Jersey 08903|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|
|Lankenau Cancer Center at Lankenau Hospital||Wynnewood, Pennsylvania 19096|
|St. Joseph's Hospital||St Paul, Minnesota 55102|