Trial Outcomes & Findings for Chemotherapy, Radiation Therapy, and Cetuximab Followed by Surgery, Docetaxel, and Cetuximab in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer (NCT NCT00551759)
NCT ID: NCT00551759
Last Updated: 2023-07-03
Results Overview
After neoadjuvant therapy, participants underwent surgical resection. The excised tumor was examined by a pathologist. A pathologic complete response is defined as the absence of any histopathologic evidence of tumor in the resected esophageal and nodal tissue specimen.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
At time of surgery (which occurred 63 to 91 days after study entry)
Results posted on
2023-07-03
Participant Flow
Participants were recruited from ECOG member institutions between June 10, 2008 and January 8, 2010. The first patient was accrued on October 2, 2008.
Participant milestones
| Measure |
Neoadjuvant Therapy, Surgery, Adjuvant Therapy
Neoadjuvant chemoradiotherapy and cetuximab: Patients (pts) receive oxaliplatin IV over 2 hours on days 1, 15, and 29, cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, and 5-FU IV over 24 hours on days 1-35. Pts also undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Pts then proceed to surgery.
Surgery: Pts undergo surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab. Pts with an R0 or R1 resection proceed to adjuvant therapy. Pts whose tumors have not been completely resected or who have metastatic disease discontinue protocol therapy and receive further therapy at the discretion of the treating physician.
Adjuvant therapy: Within 4-8 weeks after surgery, pts receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
Eligible and Began Treatment
|
21
|
|
Overall Study
Underwent Surgery
|
17
|
|
Overall Study
Received Adjuvant Therapy
|
12
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Neoadjuvant Therapy, Surgery, Adjuvant Therapy
Neoadjuvant chemoradiotherapy and cetuximab: Patients (pts) receive oxaliplatin IV over 2 hours on days 1, 15, and 29, cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, and 5-FU IV over 24 hours on days 1-35. Pts also undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Pts then proceed to surgery.
Surgery: Pts undergo surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab. Pts with an R0 or R1 resection proceed to adjuvant therapy. Pts whose tumors have not been completely resected or who have metastatic disease discontinue protocol therapy and receive further therapy at the discretion of the treating physician.
Adjuvant therapy: Within 4-8 weeks after surgery, pts receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Death
|
5
|
|
Overall Study
Ineligible
|
1
|
Baseline Characteristics
Chemotherapy, Radiation Therapy, and Cetuximab Followed by Surgery, Docetaxel, and Cetuximab in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer
Baseline characteristics by cohort
| Measure |
Neoadjuvant Therapy, Surgery, Adjuvant Therapy
n=21 Participants
Neoadjuvant chemoradiotherapy and cetuximab: Patients (pts) receive oxaliplatin IV over 2 hours on days 1, 15, and 29, cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, and 5-FU IV over 24 hours on days 1-35. Pts also undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Pts then proceed to surgery.
Surgery: Pts undergo surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab. Pts with an R0 or R1 resection proceed to adjuvant therapy. Pts whose tumors have not been completely resected or who have metastatic disease discontinue protocol therapy and receive further therapy at the discretion of the treating physician.
Adjuvant therapy: Within 4-8 weeks after surgery, pts receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At time of surgery (which occurred 63 to 91 days after study entry)Population: Eligible and treated patients
After neoadjuvant therapy, participants underwent surgical resection. The excised tumor was examined by a pathologist. A pathologic complete response is defined as the absence of any histopathologic evidence of tumor in the resected esophageal and nodal tissue specimen.
Outcome measures
| Measure |
Neoadjuvant Therapy, Surgery, Adjuvant Therapy
n=21 Participants
Neoadjuvant chemoradiotherapy and cetuximab: Patients (pts) receive oxaliplatin IV over 2 hours on days 1, 15, and 29, cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, and 5-FU IV over 24 hours on days 1-35. Pts also undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Pts then proceed to surgery.
Surgery: Pts undergo surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab. Pts with an R0 or R1 resection proceed to adjuvant therapy. Pts whose tumors have not been completely resected or who have metastatic disease discontinue protocol therapy and receive further therapy at the discretion of the treating physician.
Adjuvant therapy: Within 4-8 weeks after surgery, pts receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Proportion of Patients With Pathologic Complete Response
|
0.33 Proportion of patients
Interval 0.168 to 0.536
|
Adverse Events
Neoadjuvant Therapy, Surgery, Adjuvant Therapy
Serious events: 19 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Neoadjuvant Therapy, Surgery, Adjuvant Therapy
n=22 participants at risk
35 days of neoadjuvant chemoradiotherapy with oxaliplatin and infusional 5-fluorouracil plus cetuximab followed by post-operative docetaxel and cetuximab.
|
|---|---|
|
Immune system disorders
Allergic reaction
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Anemia
|
18.2%
4/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Leukocytes decreased
|
9.1%
2/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lymphopenia
|
22.7%
5/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophils decreased
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelets decreased
|
9.1%
2/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Heart block asystole
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Atrial fibrillation
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Cardiac troponin I (cTnI) increased
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypotension
|
9.1%
2/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
22.7%
5/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Weight loss
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Activated partial thromboplastin time pr
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Coagulation-other
|
9.1%
2/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Injury, poisoning and procedural complications
Radiation dermatitis
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Death - multiorgan failure
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
22.7%
5/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Constipation
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
36.4%
8/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
18.2%
4/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Distention/bloating, abdominal
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dysphagia
|
13.6%
3/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Esophagitis
|
22.7%
5/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Malabsorption
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) esophagus
|
13.6%
3/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
22.7%
5/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Necrosis, small bowel NOS
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Perforation, colon
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Stenosis (incl anastomotic) esophagus
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
2/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Injury, poisoning and procedural complications
Surgical hemorrhage
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, brain
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, colon
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, lung
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, sm bowel
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ unk ANC wound
|
9.1%
2/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, blood
|
9.1%
2/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
13.6%
3/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alkaline phosphatase increased
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
18.2%
4/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
9.1%
2/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.1%
2/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Laryngeal nerve dysfunction
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Neuropathy-motor
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Depressed level of consciousness
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Syncope
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Abdomen, pain
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Esophagus, pain
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
(ARDS)
|
18.2%
4/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
2/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
18.2%
4/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
9.1%
2/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
9.1%
2/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-other
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Injury, poisoning and procedural complications
Vascular access,Thrombosis/embolism
|
4.5%
1/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
13.6%
3/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
Other adverse events
| Measure |
Neoadjuvant Therapy, Surgery, Adjuvant Therapy
n=22 participants at risk
35 days of neoadjuvant chemoradiotherapy with oxaliplatin and infusional 5-fluorouracil plus cetuximab followed by post-operative docetaxel and cetuximab.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
72.7%
16/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Leukocytes decreased
|
22.7%
5/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lymphopenia
|
13.6%
3/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophils decreased
|
27.3%
6/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelets decreased
|
40.9%
9/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Palpitations
|
9.1%
2/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypotension
|
9.1%
2/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
81.8%
18/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fever w/o neutropenia
|
22.7%
5/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Insomnia
|
13.6%
3/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Weight loss
|
45.5%
10/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
27.3%
6/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
13.6%
3/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
9.1%
2/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
22.7%
5/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
40.9%
9/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Injury, poisoning and procedural complications
Radiation dermatitis
|
22.7%
5/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
36.4%
8/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
45.5%
10/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Constipation
|
36.4%
8/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
13.6%
3/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
50.0%
11/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dysphagia
|
13.6%
3/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Esophagitis
|
13.6%
3/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
18.2%
4/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) esophagus
|
45.5%
10/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
68.2%
15/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Salivary
|
13.6%
3/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Taste disturbance
|
9.1%
2/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
11/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nose, hemorrhage
|
9.1%
2/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Edema limb
|
9.1%
2/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
31.8%
7/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alkaline phosphatase increased
|
9.1%
2/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alanine aminotransferase increased
|
13.6%
3/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
13.6%
3/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Acidosis
|
9.1%
2/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
45.5%
10/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
13.6%
3/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
31.8%
7/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
27.3%
6/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
18.2%
4/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Dizziness
|
13.6%
3/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Depression
|
13.6%
3/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Neuropathy-motor
|
13.6%
3/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Neuropathy-sensory
|
50.0%
11/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Abdomen, pain
|
9.1%
2/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Chest/thoracic pain NOS
|
9.1%
2/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Esophagus, pain
|
18.2%
4/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Head/headache
|
18.2%
4/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
13.6%
3/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.3%
6/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.2%
4/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
18.2%
4/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
13.6%
3/22 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
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Additional Information
Study Statistician
ECOG Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place