Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer
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
3 other identifiers
interventional
97
1 country
23
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy before and after surgery may kill more tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of combining radiation therapy with two different chemotherapy regimens before and after surgery in treating patients who have esophageal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2002
Longer than P75 for phase_2
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2002
CompletedStudy Start
First participant enrolled
August 15, 2002
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
July 19, 2011
CompletedJune 28, 2023
June 1, 2023
7.1 years
April 9, 2002
June 21, 2011
June 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Overall Survival Time
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
Recurrence-free Survival Time
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
Study Arms (2)
Cisplatin / Irinotecan / Radiation therapy (Arm A)
EXPERIMENTALDays 1 - 35 : Concurrent radiation therapy (RT) and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles
Paclitaxel / Cisplatin / Radiation therapy (Arm B)
EXPERIMENTALDays 1 - 35 : Concurrent radiation therapy (RT) and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy. Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles.
Interventions
Days 1 - 35 : Cisplatin 30 mg/m² days 1, 8, 15, 22, 29 Days 63 - 77 : cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles
Days 1 - 35 : Irinotecan 65 mg/m² days 1, 8, 22, 29 Days 63 - 77 : irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles
Days 1 - 35 : Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29 Days 63 - 77 : paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles
The type of resection (lvor-Lewis, Transhiatal, etc.) was left to the discretion of the operating surgeon. One lymph node dissection was required.
The total dose to the prescription point was 4500 cGy given in 25 fractions. The patient was treated with one fraction per day with all fields treated per day. 180 cGy was delivered to the isocenter. If the dose to the supraclavicular fossa (SCF) was less than 4500 cGy, a localized photon or electron boost was allowed in order to increase the SCF dose to 4500 cGy, specified at 3 cm depth from the anterior skin surface.
Eligibility Criteria
You may qualify if:
- Newly diagnosed adenocarcinoma of the esophagus (20 cm below incisors) or gastroesophageal junction
- Stage T2-3, N0, M0 OR
- Stage T1-3, N0-1, M0 or M1A (celiac nodal metastasis)
- Tumor must be considered surgically resectable (T1-3, but not T4)
- Age\>=18 years
- ECOG Performance status 0-1
- Adequate hematopoietic, hepatic, renal functions defined by the following within 4 weeks prior to randomization:
- Granulocyte count at least 1,000/mm\^3
- Platelet count at least 100,000/mm\^3
- Bilirubin no greater than 1.5 mg/dL
- Creatinine clearance at least 60 mL/min
- Prior curatively treated malignancy allowed if currently disease-free and survival prognosis is more than 5 years
- Fertile patients must use effective contraception
- Endoscopy with biopsy and dilation allowed
You may not qualify if:
- Tumor extends more than 2 cm into the cardia
- Pregnant or nursing
- Other concurrent illness that would preclude study therapy or surgical resection
- Concurrent filgrastim (G-CSF) during study radiotherapy
- Prior chemotherapy
- Prior radiotherapy
- Prior surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, 80224, United States
CCOP - Christiana Care Health Services
Newark, Delaware, 19713, United States
Shands Cancer Center at the University of Florida Health Science Center
Gainesville, Florida, 32610-100277, United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, 60611-4494, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611, United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
St. Joseph's Hospital
Saint Paul, Minnesota, 55102, United States
Cancer Institute of New Jersey at Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903, United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065, United States
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, 43623-3456, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, 19096, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104, United States
CCOP - Scott and White Hospital
Temple, Texas, 76508, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54307-3453, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-0001, United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449, United States
Related Publications (2)
Kleinberg L, Powell ME, Forastiere AA, et al.: Survival outcome of E1201: An Eastern Cooperative Oncology Group (ECOG) randomized phase II trial of neoadjuvant preoperative paclitaxel/cisplatin/radiotherapy (RT) or irinotecan/cisplatin/RT in endoscopy with ultrasound (EUS) staged esophageal adenocarcinoma. [Abstract] J Clin Oncol 26 (Suppl15): A-4532, 2008.
RESULTKleinberg LR, Eapen S, Hamilton S, et al.: E1201: an Eastern Cooperative Oncology Group (ECOG) randomized phase II trial to measure response rate and toxicity of preoperative combined modality paclitaxel/cisplatin/RT or irinotecan/cisplatin/RT in adenocarcinoma of the esophagus. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-143, S80, 2006.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- Eastern Cooperative Oncology Group (ECOG) Statistical Office
Study Officials
- STUDY CHAIR
Larry Kleinberg, MD
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2002
First Posted
January 27, 2003
Study Start
August 15, 2002
Primary Completion
September 1, 2009
Study Completion
October 1, 2009
Last Updated
June 28, 2023
Results First Posted
July 19, 2011
Record last verified: 2023-06