Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:
-
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 toxicity.
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Cisplatin / Irinotecan / Radiation therapy (Arm A) Days 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 |
Drug: cisplatin
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
Other Names:
Drug: irinotecan hydrochloride
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
Other Names:
Procedure: conventional surgery
The type of resection (lvor-Lewis, Transhiatal, etc.) was left to the discretion of the operating surgeon. One lymph node dissection was required.
Radiation: radiation therapy
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.
|
Experimental: Paclitaxel / Cisplatin / Radiation therapy (Arm B) Days 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. |
Drug: cisplatin
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
Other Names:
Drug: paclitaxel
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
Other Names:
Procedure: conventional surgery
The type of resection (lvor-Lewis, Transhiatal, etc.) was left to the discretion of the operating surgeon. One lymph node dissection was required.
Radiation: radiation therapy
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.
|
Outcome Measures
Primary Outcome Measures
- Pathologic Complete Response Rate [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]
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.
Secondary Outcome Measures
- 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]
Survival was measured from the date of randomization onto study to death from any cause.Patients who were still alive at the end of the study were censored at the last date of known alive. Median survival time was calculated in the 81 eligible and treated patients.
- 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]
Recurrence-free survival is measured from the date of complete response to recurrence of the cancer. Patients without recurrence were censored at the last date of known recurrence-free. Median recurrence-free survival time was calculated in the eligible and treated patients.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
Exclusion Criteria:
-
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | CCOP - Colorado Cancer Research Program, Incorporated | Denver | Colorado | United States | 80224 |
2 | CCOP - Christiana Care Health Services | Newark | Delaware | United States | 19713 |
3 | Shands Cancer Center at the University of Florida Health Science Center | Gainesville | Florida | United States | 32610-100277 |
4 | Veterans Affairs Medical Center - Lakeside Chicago | Chicago | Illinois | United States | 60611-4494 |
5 | Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | United States | 60611 |
6 | CCOP - Carle Cancer Center | Urbana | Illinois | United States | 61801 |
7 | CCOP - Iowa Oncology Research Association | Des Moines | Iowa | United States | 50309-1016 |
8 | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | United States | 21231 |
9 | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | United States | 48106 |
10 | Mayo Clinic Cancer Center | Rochester | Minnesota | United States | 55905 |
11 | CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | United States | 55416 |
12 | St. Joseph's Hospital | Saint Paul | Minnesota | United States | 55102 |
13 | Cancer Institute of New Jersey at Robert Wood Johnson University Hospital | New Brunswick | New Jersey | United States | 08903 |
14 | Ireland Cancer Center | Cleveland | Ohio | United States | 44106-5065 |
15 | MetroHealth's Cancer Care Center at MetroHealth Medical Center | Cleveland | Ohio | United States | 44109 |
16 | CCOP - Toledo Community Hospital | Toledo | Ohio | United States | 43623-3456 |
17 | CCOP - MainLine Health | Wynnewood | Pennsylvania | United States | 19096 |
18 | Lankenau Cancer Center at Lankenau Hospital | Wynnewood | Pennsylvania | United States | 19096 |
19 | CCOP - Sioux Community Cancer Consortium | Sioux Falls | South Dakota | United States | 57104 |
20 | CCOP - Scott and White Hospital | Temple | Texas | United States | 76508 |
21 | CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay | Wisconsin | United States | 54307-3453 |
22 | University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin | United States | 53792-0001 |
23 | CCOP - Marshfield Clinic Research Foundation | Marshfield | Wisconsin | United States | 54449 |
Sponsors and Collaborators
- Eastern Cooperative Oncology Group
- National Cancer Institute (NCI)
Investigators
- Study Chair: Larry Kleinberg, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000069309
- U10CA021115
- E1201
Study Results
Participant Flow
Recruitment Details | E1201 opened to accrual on May 21, 2002 and accrued its first patient on August 15, 2002. A total of 97 patients were accrued from 19 different participating sites. |
---|---|
Pre-assignment Detail |
Arm/Group Title | Cisplatin / Irinotecan / RT (Arm A) | Paclitaxel / Cisplatin / RT (Arm B) |
---|---|---|
Arm/Group Description | Days 1 - 35 : Concurrent radiation therapy 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 | Days 1 - 35 : Concurrent 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. |
Period Title: Neoadjuvant Chemotherapy | ||
STARTED | 50 | 47 |
Eligible | 42 | 43 |
Eligible and Treated | 39 | 42 |
COMPLETED | 36 | 36 |
NOT COMPLETED | 14 | 11 |
Period Title: Neoadjuvant Chemotherapy | ||
STARTED | 36 | 36 |
COMPLETED | 36 | 33 |
NOT COMPLETED | 0 | 3 |
Period Title: Neoadjuvant Chemotherapy | ||
STARTED | 36 | 33 |
COMPLETED | 18 | 16 |
NOT COMPLETED | 18 | 17 |
Baseline Characteristics
Arm/Group Title | Cisplatin / Irinotecan / RT (Arm A) | Paclitaxel / Cisplatin / RT (Arm B) | Total |
---|---|---|---|
Arm/Group Description | Days 1 - 35 : Concurrent radiation therapy 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 | Days 1 - 35 : Concurrent 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. | Total of all reporting groups |
Overall Participants | 39 | 42 | 81 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
56.2
(9.7)
|
59.9
(10.7)
|
58.1
(10.3)
|
Sex: Female, Male (Count of Participants) | |||
Female |
4
10.3%
|
7
16.7%
|
11
13.6%
|
Male |
35
89.7%
|
35
83.3%
|
70
86.4%
|
Region of Enrollment (participants) [Number] | |||
United States |
39
100%
|
42
100%
|
81
100%
|
Outcome Measures
Title | Pathologic Complete Response Rate |
---|---|
Description | 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. |
Time Frame | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Eligible, treated patients |
Arm/Group Title | Cisplatin / Irinotecan / RT (Arm A) | Paclitaxel / Cisplatin / RT (Arm B) |
---|---|---|
Arm/Group Description | Days 1 - 35 : Concurrent radiation therapy 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 | Days 1 - 35 : Concurrent 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. |
Measure Participants | 39 | 42 |
Number (90% Confidence Interval) [percentage of participants] |
15.4
39.5%
|
16.7
39.8%
|
Title | Overall Survival Time |
---|---|
Description | Survival was measured from the date of randomization onto study to death from any cause.Patients who were still alive at the end of the study were censored at the last date of known alive. Median survival time was calculated in the 81 eligible and treated patients. |
Time Frame | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Eligible, treated patients |
Arm/Group Title | Cisplatin / Irinotecan / RT (Arm A) | Paclitaxel / Cisplatin / RT (Arm B) |
---|---|---|
Arm/Group Description | Days 1 - 35 : Concurrent radiation therapy 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 | Days 1 - 35 : Concurrent 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. |
Measure Participants | 39 | 42 |
Median (95% Confidence Interval) [Months] |
35.0
|
21.0
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Cisplatin / Irinotecan / RT (Arm A), Paclitaxel / Cisplatin / RT (Arm B) |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.48 |
Comments | ||
Method | Log Rank | |
Comments |
Title | Recurrence-free Survival Time |
---|---|
Description | Recurrence-free survival is measured from the date of complete response to recurrence of the cancer. Patients without recurrence were censored at the last date of known recurrence-free. Median recurrence-free survival time was calculated in the eligible and treated patients. |
Time Frame | 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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Cisplatin / Irinotecan / RT (Arm A) | Paclitaxel / Cisplatin / RT (Arm B) |
---|---|---|
Arm/Group Description | Days 1 - 35 : Concurrent radiation therapy 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 | Days 1 - 35 : Concurrent 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. |
Measure Participants | 39 | 42 |
Median (95% Confidence Interval) [Months] |
39.8
|
12.4
|
Adverse Events
Time Frame | Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy | |||||||
---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||||
Arm/Group Title | Neoadjuvant_Cisplatin / Irinotecan / RT (Arm A) | Neoadjuvant_Paclitaxel / Cisplatin / RT (Arm B) | Adjuvant_Cisplatin / Irinotecan / RT ( Arm A) | Adjuvant_Paclitaxel / Irinotecan / RT ( Arm B) | ||||
Arm/Group Description | Days 1 - 35 : Concurrent radiation therapy 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 | Days 1 - 35 : Concurrent 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. | Adjuvant chemotherapy toxicities in treated patients | |||||
All Cause Mortality |
||||||||
Neoadjuvant_Cisplatin / Irinotecan / RT (Arm A) | Neoadjuvant_Paclitaxel / Cisplatin / RT (Arm B) | Adjuvant_Cisplatin / Irinotecan / RT ( Arm A) | Adjuvant_Paclitaxel / Irinotecan / RT ( Arm B) | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
Neoadjuvant_Cisplatin / Irinotecan / RT (Arm A) | Neoadjuvant_Paclitaxel / Cisplatin / RT (Arm B) | Adjuvant_Cisplatin / Irinotecan / RT ( Arm A) | Adjuvant_Paclitaxel / Irinotecan / RT ( Arm B) | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 32/47 (68.1%) | 30/46 (65.2%) | 20/31 (64.5%) | 15/27 (55.6%) | ||||
Blood and lymphatic system disorders | ||||||||
Transfusion:PRBCS | 0/47 (0%) | 1/46 (2.2%) | 0/31 (0%) | 0/27 (0%) | ||||
Thrombosis/Embolism | 1/47 (2.1%) | 1/46 (2.2%) | 0/31 (0%) | 0/27 (0%) | ||||
Febrile neutropenia | 2/47 (4.3%) | 2/46 (4.3%) | 1/31 (3.2%) | 2/27 (7.4%) | ||||
Anemia | 0/47 (0%) | 0/46 (0%) | 1/31 (3.2%) | 0/27 (0%) | ||||
Cardiac disorders | ||||||||
Sinus bradycardia | 0/47 (0%) | 1/46 (2.2%) | 0/31 (0%) | 0/27 (0%) | ||||
Chest pain | 1/47 (2.1%) | 0/46 (0%) | 0/31 (0%) | 0/27 (0%) | ||||
Gastrointestinal disorders | ||||||||
Constipation | 1/47 (2.1%) | 0/46 (0%) | 0/31 (0%) | 0/27 (0%) | ||||
Dysphagia | 0/47 (0%) | 1/46 (2.2%) | 1/31 (3.2%) | 0/27 (0%) | ||||
Nausea | 11/47 (23.4%) | 6/46 (13%) | 1/31 (3.2%) | 3/27 (11.1%) | ||||
Vomiting | 4/47 (8.5%) | 4/46 (8.7%) | 3/31 (9.7%) | 4/27 (14.8%) | ||||
Diarrhea w/o prior colostomy | 4/47 (8.5%) | 1/46 (2.2%) | 5/31 (16.1%) | 3/27 (11.1%) | ||||
Abdominal pain | 1/47 (2.1%) | 0/46 (0%) | 2/31 (6.5%) | 0/27 (0%) | ||||
General disorders | ||||||||
Fatigue | 2/47 (4.3%) | 5/46 (10.9%) | 2/31 (6.5%) | 2/27 (7.4%) | ||||
Fever | 0/47 (0%) | 1/46 (2.2%) | 1/31 (3.2%) | 0/27 (0%) | ||||
Pain-other | 0/47 (0%) | 1/46 (2.2%) | 0/31 (0%) | 0/27 (0%) | ||||
Hepatobiliary disorders | ||||||||
AST increased | 0/47 (0%) | 1/46 (2.2%) | 0/31 (0%) | 0/27 (0%) | ||||
ALT increased | 1/47 (2.1%) | 1/46 (2.2%) | 0/31 (0%) | 1/27 (3.7%) | ||||
Infections and infestations | ||||||||
Infection w/o neutropenia | 1/47 (2.1%) | 0/46 (0%) | 1/31 (3.2%) | 0/27 (0%) | ||||
Injury, poisoning and procedural complications | ||||||||
Dysphagia-esophageal radiation | 6/47 (12.8%) | 8/46 (17.4%) | 0/31 (0%) | 1/27 (3.7%) | ||||
Mucositis due to radiation | 1/47 (2.1%) | 0/46 (0%) | 0/31 (0%) | 0/27 (0%) | ||||
Pain due to radiation | 2/47 (4.3%) | 1/46 (2.2%) | 0/31 (0%) | 0/27 (0%) | ||||
Dysphagia-pharyngeal radiation | 0/47 (0%) | 0/46 (0%) | 0/31 (0%) | 1/27 (3.7%) | ||||
Investigations | ||||||||
Leukopenia | 17/47 (36.2%) | 16/46 (34.8%) | 15/31 (48.4%) | 6/27 (22.2%) | ||||
Lymphopenia | 0/47 (0%) | 1/46 (2.2%) | 0/31 (0%) | 1/27 (3.7%) | ||||
Neutropenia | 15/47 (31.9%) | 13/46 (28.3%) | 16/31 (51.6%) | 8/27 (29.6%) | ||||
Thrombocytopenia | 1/47 (2.1%) | 1/46 (2.2%) | 1/31 (3.2%) | 0/27 (0%) | ||||
Weight loss | 1/47 (2.1%) | 1/46 (2.2%) | 3/31 (9.7%) | 3/27 (11.1%) | ||||
Bilirubin increased | 1/47 (2.1%) | 0/46 (0%) | 1/31 (3.2%) | 0/27 (0%) | ||||
Creatinine increased | 0/47 (0%) | 1/46 (2.2%) | 0/31 (0%) | 0/27 (0%) | ||||
Metabolism and nutrition disorders | ||||||||
Anorexia | 9/47 (19.1%) | 2/46 (4.3%) | 5/31 (16.1%) | 2/27 (7.4%) | ||||
Dehydration | 4/47 (8.5%) | 4/46 (8.7%) | 1/31 (3.2%) | 4/27 (14.8%) | ||||
Hyperglycemia | 1/47 (2.1%) | 2/46 (4.3%) | 0/31 (0%) | 2/27 (7.4%) | ||||
Hypocalcemia | 0/47 (0%) | 2/46 (4.3%) | 0/31 (0%) | 0/27 (0%) | ||||
Hypokalemia | 1/47 (2.1%) | 1/46 (2.2%) | 0/31 (0%) | 1/27 (3.7%) | ||||
Hypomagnesemia | 1/47 (2.1%) | 1/46 (2.2%) | 0/31 (0%) | 1/27 (3.7%) | ||||
Hyponatremia | 0/47 (0%) | 4/46 (8.7%) | 1/31 (3.2%) | 1/27 (3.7%) | ||||
Hypophosphatemia | 1/47 (2.1%) | 0/46 (0%) | 0/31 (0%) | 0/27 (0%) | ||||
Nervous system disorders | ||||||||
Dizziness/lightheadedness | 1/47 (2.1%) | 0/46 (0%) | 0/31 (0%) | 0/27 (0%) | ||||
Neuropathy-motor | 1/47 (2.1%) | 0/46 (0%) | 0/31 (0%) | 0/27 (0%) | ||||
Syncope | 1/47 (2.1%) | 0/46 (0%) | 1/31 (3.2%) | 1/27 (3.7%) | ||||
Tremor | 0/47 (0%) | 1/46 (2.2%) | 0/31 (0%) | 0/27 (0%) | ||||
Neuropathic pain | 0/47 (0%) | 1/46 (2.2%) | 0/31 (0%) | 0/27 (0%) | ||||
Renal and urinary disorders | ||||||||
Urinary electrolyte wasting | 0/47 (0%) | 1/46 (2.2%) | 0/31 (0%) | 0/27 (0%) | ||||
Reproductive system and breast disorders | ||||||||
Erectile impotence | 0/47 (0%) | 1/46 (2.2%) | 0/31 (0%) | 0/27 (0%) | ||||
Respiratory, thoracic and mediastinal disorders | ||||||||
Dyspnea | 0/47 (0%) | 0/46 (0%) | 0/31 (0%) | 1/27 (3.7%) | ||||
Vascular disorders | ||||||||
Hypertension | 1/47 (2.1%) | 0/46 (0%) | 0/31 (0%) | 0/27 (0%) | ||||
Hypotension | 2/47 (4.3%) | 1/46 (2.2%) | 0/31 (0%) | 0/27 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
Neoadjuvant_Cisplatin / Irinotecan / RT (Arm A) | Neoadjuvant_Paclitaxel / Cisplatin / RT (Arm B) | Adjuvant_Cisplatin / Irinotecan / RT ( Arm A) | Adjuvant_Paclitaxel / Irinotecan / RT ( Arm B) | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 47/47 (100%) | 46/46 (100%) | 30/31 (96.8%) | 25/27 (92.6%) | ||||
Blood and lymphatic system disorders | ||||||||
Anemia | 38/47 (80.9%) | 40/46 (87%) | 28/31 (90.3%) | 22/27 (81.5%) | ||||
Ear and labyrinth disorders | ||||||||
Inner ear/hearing imparied | 2/47 (4.3%) | 2/46 (4.3%) | 2/31 (6.5%) | 1/27 (3.7%) | ||||
Gastrointestinal disorders | ||||||||
Constipation | 10/47 (21.3%) | 12/46 (26.1%) | 3/31 (9.7%) | 2/27 (7.4%) | ||||
Dyspepsia | 7/47 (14.9%) | 4/46 (8.7%) | 3/31 (9.7%) | 1/27 (3.7%) | ||||
Dysphagia | 4/47 (8.5%) | 4/46 (8.7%) | 1/31 (3.2%) | 2/27 (7.4%) | ||||
Mouth dryness | 3/47 (6.4%) | 3/46 (6.5%) | 1/31 (3.2%) | 2/27 (7.4%) | ||||
Nausea | 26/47 (55.3%) | 30/46 (65.2%) | 19/31 (61.3%) | 14/27 (51.9%) | ||||
Stomatitis | 3/47 (6.4%) | 8/46 (17.4%) | 0/31 (0%) | 0/27 (0%) | ||||
Taste disturbance | 9/47 (19.1%) | 15/46 (32.6%) | 8/31 (25.8%) | 10/27 (37%) | ||||
Vomiting | 20/47 (42.6%) | 16/46 (34.8%) | 10/31 (32.3%) | 9/27 (33.3%) | ||||
Diarrhea w/o prior colostomy | 17/47 (36.2%) | 16/46 (34.8%) | 14/31 (45.2%) | 13/27 (48.1%) | ||||
Abonominal pain | 8/47 (17%) | 7/46 (15.2%) | 5/31 (16.1%) | 7/27 (25.9%) | ||||
Flatulence | 1/47 (2.1%) | 0/46 (0%) | 3/31 (9.7%) | 1/27 (3.7%) | ||||
General disorders | ||||||||
Edema | 1/47 (2.1%) | 4/46 (8.7%) | 1/31 (3.2%) | 0/27 (0%) | ||||
Fatigue | 32/47 (68.1%) | 33/46 (71.7%) | 23/31 (74.2%) | 19/27 (70.4%) | ||||
Hepatobiliary disorders | ||||||||
AST increased | 5/47 (10.6%) | 9/46 (19.6%) | 2/31 (6.5%) | 3/27 (11.1%) | ||||
ALT increased | 17/47 (36.2%) | 17/46 (37%) | 5/31 (16.1%) | 6/27 (22.2%) | ||||
Injury, poisoning and procedural complications | ||||||||
Radiation dermatitis | 8/47 (17%) | 6/46 (13%) | 0/31 (0%) | 0/27 (0%) | ||||
Dysphagia-esophageal radiation | 18/47 (38.3%) | 21/46 (45.7%) | 3/31 (9.7%) | 2/27 (7.4%) | ||||
Dysphagia-pharyngeal radiation | 7/47 (14.9%) | 2/46 (4.3%) | 1/31 (3.2%) | 0/27 (0%) | ||||
Investigations | ||||||||
Leukopenia | 44/47 (93.6%) | 41/46 (89.1%) | 27/31 (87.1%) | 17/27 (63%) | ||||
Neutropenia | 35/47 (74.5%) | 24/46 (52.2%) | 23/31 (74.2%) | 9/27 (33.3%) | ||||
Thrombocytopenia | 31/47 (66%) | 29/46 (63%) | 21/31 (67.7%) | 8/27 (29.6%) | ||||
Weight loss | 19/47 (40.4%) | 17/46 (37%) | 15/31 (48.4%) | 10/27 (37%) | ||||
Alkaline phosphatase increased | 10/47 (21.3%) | 7/46 (15.2%) | 10/31 (32.3%) | 7/27 (25.9%) | ||||
Bilirubin increased | 4/47 (8.5%) | 6/46 (13%) | 1/31 (3.2%) | 0/27 (0%) | ||||
Creatinine increased | 8/47 (17%) | 12/46 (26.1%) | 3/31 (9.7%) | 8/27 (29.6%) | ||||
Metabolism and nutrition disorders | ||||||||
Anorexia | 21/47 (44.7%) | 18/46 (39.1%) | 11/31 (35.5%) | 14/27 (51.9%) | ||||
Dehydration | 6/47 (12.8%) | 12/46 (26.1%) | 4/31 (12.9%) | 2/27 (7.4%) | ||||
Hypoalbuminemia | 4/47 (8.5%) | 4/46 (8.7%) | 1/31 (3.2%) | 1/27 (3.7%) | ||||
Hyperglycemia | 7/47 (14.9%) | 9/46 (19.6%) | 3/31 (9.7%) | 3/27 (11.1%) | ||||
Hypocalcemia | 6/47 (12.8%) | 6/46 (13%) | 2/31 (6.5%) | 0/27 (0%) | ||||
Hypokalemia | 5/47 (10.6%) | 4/46 (8.7%) | 3/31 (9.7%) | 3/27 (11.1%) | ||||
Hypomagnesemia | 3/47 (6.4%) | 7/46 (15.2%) | 4/31 (12.9%) | 1/27 (3.7%) | ||||
Hyponatremia | 2/47 (4.3%) | 9/46 (19.6%) | 2/31 (6.5%) | 1/27 (3.7%) | ||||
Musculoskeletal and connective tissue disorders | ||||||||
Myalgia | 1/47 (2.1%) | 3/46 (6.5%) | 0/31 (0%) | 2/27 (7.4%) | ||||
Arthralgia | 0/47 (0%) | 0/46 (0%) | 0/31 (0%) | 3/27 (11.1%) | ||||
Nervous system disorders | ||||||||
Dizziness/lightheadedness | 5/47 (10.6%) | 11/46 (23.9%) | 2/31 (6.5%) | 2/27 (7.4%) | ||||
Neuropathy-sensory | 4/47 (8.5%) | 7/46 (15.2%) | 3/31 (9.7%) | 12/27 (44.4%) | ||||
Psychiatric disorders | ||||||||
Insomnia | 4/47 (8.5%) | 2/46 (4.3%) | 1/31 (3.2%) | 2/27 (7.4%) | ||||
Anxiety/agitation | 3/47 (6.4%) | 4/46 (8.7%) | 1/31 (3.2%) | 3/27 (11.1%) | ||||
Renal and urinary disorders | ||||||||
Dysuria | 1/47 (2.1%) | 3/46 (6.5%) | 1/31 (3.2%) | 0/27 (0%) | ||||
Respiratory, thoracic and mediastinal disorders | ||||||||
Dyspnea | 5/47 (10.6%) | 4/46 (8.7%) | 2/31 (6.5%) | 1/27 (3.7%) | ||||
Allergic rhinitis | 2/47 (4.3%) | 0/46 (0%) | 3/31 (9.7%) | 0/27 (0%) | ||||
Cough | 2/47 (4.3%) | 2/46 (4.3%) | 2/31 (6.5%) | 3/27 (11.1%) | ||||
Skin and subcutaneous tissue disorders | ||||||||
Alopecia | 12/47 (25.5%) | 13/46 (28.3%) | 10/31 (32.3%) | 14/27 (51.9%) | ||||
Rash/desquamation | 0/47 (0%) | 4/46 (8.7%) | 1/31 (3.2%) | 1/27 (3.7%) | ||||
Vascular disorders | ||||||||
Hypotension | 1/47 (2.1%) | 1/46 (2.2%) | 2/31 (6.5%) | 0/27 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Study Statistician |
---|---|
Organization | Eastern Cooperative Oncology Group (ECOG) Statistical Office |
Phone | 617-632-3012 |
- CDR0000069309
- U10CA021115
- E1201