Trial Outcomes & Findings for Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer (NCT NCT00003298)
NCT ID: NCT00003298
Last Updated: 2023-07-06
Results Overview
Incidence is defined as proportion of patients with any grade 3 or higher treatment-related toxicities among all treated patients.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
assessed at the end of every cycle (cycle=21 days) during treatment (3 cycles in total)
Results posted on
2023-07-06
Participant Flow
E7296 was activated on February 25, 1999, accrued its first patient on June 1, 1999, and terminated on March 18, 2002 with a final accrual of 39 patients (accrual goal: 42 patients) enrolled by 13 ECOG affiliated institutions.
Participant milestones
| Measure |
Experimental Arm
Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
|
|---|---|
|
Step 1 (Neoadjuvant Therapy)
STARTED
|
39
|
|
Step 1 (Neoadjuvant Therapy)
Eligible and Treated
|
38
|
|
Step 1 (Neoadjuvant Therapy)
Complete 3 Cycles of Neoadjuvant Therapy
|
35
|
|
Step 1 (Neoadjuvant Therapy)
COMPLETED
|
35
|
|
Step 1 (Neoadjuvant Therapy)
NOT COMPLETED
|
4
|
|
Surgery
STARTED
|
35
|
|
Surgery
COMPLETED
|
28
|
|
Surgery
NOT COMPLETED
|
7
|
|
Re-register to Step 2 After Surgery
STARTED
|
28
|
|
Re-register to Step 2 After Surgery
COMPLETED
|
10
|
|
Re-register to Step 2 After Surgery
NOT COMPLETED
|
18
|
|
Step 2 (Adjuvant Therapy)
STARTED
|
10
|
|
Step 2 (Adjuvant Therapy)
Eligible and Treated on Step 2
|
7
|
|
Step 2 (Adjuvant Therapy)
COMPLETED
|
4
|
|
Step 2 (Adjuvant Therapy)
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Experimental Arm
Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
|
|---|---|
|
Step 1 (Neoadjuvant Therapy)
Ineligible for step 1
|
1
|
|
Step 1 (Neoadjuvant Therapy)
Adverse Event
|
3
|
|
Surgery
Unresectable at surgery
|
3
|
|
Surgery
Progression before surgery
|
2
|
|
Surgery
Unevaluable and off study
|
2
|
|
Re-register to Step 2 After Surgery
Less than 15 nodes examined
|
7
|
|
Re-register to Step 2 After Surgery
Positive margins
|
5
|
|
Re-register to Step 2 After Surgery
Other complications
|
2
|
|
Re-register to Step 2 After Surgery
Reason unknown
|
1
|
|
Re-register to Step 2 After Surgery
Ineligible due to tumor staging
|
3
|
|
Step 2 (Adjuvant Therapy)
Ineligible
|
1
|
|
Step 2 (Adjuvant Therapy)
Death
|
1
|
|
Step 2 (Adjuvant Therapy)
Progression before starting treatment
|
1
|
|
Step 2 (Adjuvant Therapy)
Excessive complication
|
1
|
|
Step 2 (Adjuvant Therapy)
Withdrawal by Subject
|
2
|
Baseline Characteristics
Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer
Baseline characteristics by cohort
| Measure |
Experimental Arm
n=38 Participants
Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
|
|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: assessed at the end of every cycle (cycle=21 days) during treatment (3 cycles in total)Population: eligible and treated patients on step 1
Incidence is defined as proportion of patients with any grade 3 or higher treatment-related toxicities among all treated patients.
Outcome measures
| Measure |
Experimental Arm
n=38 Participants
Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
|
|---|---|
|
Grade 3 or Higher Toxicity Incidence on Step 1
|
65.8 percentage of participants
Interval 48.6 to 80.4
|
SECONDARY outcome
Timeframe: Assessed at surgery time (surgery performed during week 8-10 after registration to the study)Population: Eligible and treated patients on step 1. Since no patient had a complete response in the study, one-sided 95% confidence interval was provided here.
Response was based on pathology at surgery. A patient achieved complete response if no gross or microscopic tumor were identified with the surgical specimen and nodal tissue. Stable response was defined as a response that did not qualify as complete response or progressive disease (PD), where PD indicated metastatic spread. Best confirmed response rate was defined as the proportion of patients with complete response (CR). A patient was considered unevaluable if the patient did not have surgery, the pathologist did not examine at least 15 lymph nodes, or the pathology report was unavailable.
Outcome measures
| Measure |
Experimental Arm
n=38 Participants
Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
|
|---|---|
|
Best Confirmed Response to Neoadjuvant Therapy
|
0 percentage of participants
Interval 0.0 to 7.58
|
SECONDARY outcome
Timeframe: assessed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter up to year 10Population: eligible and treated patients on step 1
Overall survival was defined as the time from registration to death, where a subject was censored on date of last record alive.
Outcome measures
| Measure |
Experimental Arm
n=38 Participants
Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
|
|---|---|
|
Overall Survival
|
1.55 years
Interval 1.24 to 2.23
|
SECONDARY outcome
Timeframe: assessed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter up to year 10Population: eligible and treated patients on step 1
Progression-free survival (PFS) was defined as time from registration until progression, recurrence, or death, whichever occurred first. If date of death occurred beyond three months from the date of last disease assessment, then PFS was censored at date of last disease assessment. Patients who were alive and progression-free were censored at the date of last disease evaluation.
Outcome measures
| Measure |
Experimental Arm
n=38 Participants
Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
|
|---|---|
|
Progression Free Survival
|
0.68 years
Interval 0.35 to 1.43
|
Adverse Events
Step 1(Neoadjuvant Therapy)
Serious events: 25 serious events
Other events: 38 other events
Deaths: 0 deaths
Step 2 (Adjuvant Therapy)
Serious events: 6 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Step 1(Neoadjuvant Therapy)
n=38 participants at risk
Patients receive 3 courses of preoperative neoadjuvant chemotherapy given on day 1 every 21 days. Courses consist of an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel on day 1.
|
Step 2 (Adjuvant Therapy)
n=7 participants at risk
After neoadjuvant therapy, patients undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
|
|---|---|---|
|
Immune system disorders
Anaphylaxis
|
2.6%
1/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Investigations
White blood cell decreased
|
10.5%
4/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
42.9%
3/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophil count decreased
|
47.4%
18/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
71.4%
5/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelet count decreased
|
2.6%
1/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
14.3%
1/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Ventricular arrhythmia
|
2.6%
1/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypotension
|
2.6%
1/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Investigations
Weight loss
|
0.00%
0/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
14.3%
1/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
2.6%
1/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
28.6%
2/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Constipation
|
2.6%
1/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
7.9%
3/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
28.6%
2/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
28.6%
2/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
2.6%
1/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
28.6%
2/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
14.3%
1/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
1/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
42.9%
3/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
28.6%
2/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alkaline phosphatase increased
|
2.6%
1/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
14.3%
1/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
14.3%
1/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
28.6%
2/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection with grade 3 or 4 neutropenia
|
0.00%
0/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
14.3%
1/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.6%
1/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.3%
2/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.9%
3/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.3%
2/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
14.3%
1/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
14.3%
1/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Confusion
|
2.6%
1/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
14.3%
1/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Dizziness
|
2.6%
1/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Depression
|
0.00%
0/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
14.3%
1/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Syncope
|
2.6%
1/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.6%
1/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
2/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Investigations
Creatinine increased
|
2.6%
1/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
Other adverse events
| Measure |
Step 1(Neoadjuvant Therapy)
n=38 participants at risk
Patients receive 3 courses of preoperative neoadjuvant chemotherapy given on day 1 every 21 days. Courses consist of an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel on day 1.
|
Step 2 (Adjuvant Therapy)
n=7 participants at risk
After neoadjuvant therapy, patients undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
|
|---|---|---|
|
Ear and labyrinth disorders
Hearing impaired
|
7.9%
3/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Anemia
|
7.9%
3/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
28.6%
2/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Investigations
White blood cell decreased
|
76.3%
29/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
100.0%
7/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophil count decreased
|
42.1%
16/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
71.4%
5/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelet count decreased
|
23.7%
9/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
57.1%
4/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Cardiac disorders - Other
|
5.3%
2/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypotension
|
5.3%
2/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
14.3%
1/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
73.7%
28/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
71.4%
5/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fever
|
5.3%
2/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Investigations
Weight loss
|
5.3%
2/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
57.1%
4/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
52.6%
20/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
57.1%
4/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
5.3%
2/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.9%
3/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.00%
0/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
28.6%
2/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
34.2%
13/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
28.6%
2/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Constipation
|
13.2%
5/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
13.2%
5/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
14.3%
1/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
2/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
14.3%
1/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
14.3%
1/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
76.3%
29/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
85.7%
6/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Mucositis oral
|
13.2%
5/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
42.9%
3/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Dysgeusia
|
10.5%
4/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
28.6%
2/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
52.6%
20/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
28.6%
2/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
14.3%
1/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
7.9%
3/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alkaline phosphatase increased
|
13.2%
5/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
28.6%
2/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Investigations
Blood bilirubin increased
|
7.9%
3/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
28.6%
2/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
14.3%
1/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
7.9%
3/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
14.3%
1/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.3%
2/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
14.3%
1/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.9%
3/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
14.3%
1/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.3%
2/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.5%
4/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
14.3%
1/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
14.3%
1/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
14.3%
1/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.3%
2/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Dizziness
|
15.8%
6/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
14.3%
1/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Anxiety
|
7.9%
3/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Depression
|
0.00%
0/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
14.3%
1/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.3%
2/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
34.2%
13/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Eye disorders
Watering eyes
|
5.3%
2/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
2/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Headache
|
7.9%
3/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
21.1%
8/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
General disorders
Pain
|
5.3%
2/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
14.3%
1/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
|
Investigations
Creatinine increased
|
18.4%
7/38 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
0.00%
0/7 • Assessed every cycle while on treatment and for 30 days after the end of treatment
|
Additional Information
Study statistician
ECOG-ACRIN Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60