Trial Outcomes & Findings for High-Dose Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Metastatic Rhabdomyosarcoma or Ectomesenchymoma (NCT NCT00354744)

Last Updated: 2020-01-29

Results Overview

Volumetric measurements of the primary tumor using an elliptical model (0.5 x the product of the 3 largest perpendicular diameters) to assess response to neoadjuvant therapy. The RECIST (Response Evaluation Criteria in Solid Tumors) from the NCI will be used for assessment of the size of measurable metastases, including nodal metastases. Primary Tumor Measurement: Technical guidelines for cross-sectional imaging computed tomography (CT) slice thickness should be 5mm or less and the diameter of the "measurable" mass should be at least twice the reconstructed slice thickness. Smaller masses are considered detectable, but will be counted as "non-measurable." Complete Response (CR): Complete disappearance of the tumor confirmed at \>4 weeks. Partial Response (PR): At least 64% decrease in volume compared to the measurement obtained at study enrollment. Progressive Disease (PD): At least 40% increase in tumor volume compared to the smallest volume obtained since the beginning.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

109 participants

Primary outcome timeframe

Protocol week 6 evaluation

Results posted on

2020-01-29

Participant Flow

Participant milestones

Participant milestones
Measure	High_Risk_Rhabdomyosarcoma Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.
Overall Study STARTED	109
Overall Study COMPLETED	67
Overall Study NOT COMPLETED	42

Reasons for withdrawal

Reasons for withdrawal
Measure	High_Risk_Rhabdomyosarcoma Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.
Overall Study Adverse Event	2
Overall Study Death	2
Overall Study Lack of Efficacy	11
Overall Study Lost to Follow-up	2
Overall Study Physician Decision	11
Overall Study Withdrawal by Subject	14

Baseline Characteristics

High-Dose Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Metastatic Rhabdomyosarcoma or Ectomesenchymoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High_Risk_Rhabdomyosarcoma n=109 Participants Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.
Age, Categorical <=18 years	96 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	11.85 years STANDARD_DEVIATION 6.55 • n=5 Participants
Sex: Female, Male Female	49 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	86 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants
Race (NIH/OMB) White	76 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants
Region of Enrollment United States	92 participants n=5 Participants
Region of Enrollment Canada	11 participants n=5 Participants
Region of Enrollment Australia	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Protocol week 6 evaluation

Population: All eligible patients with protocol week tumor assessment (N=102)

Outcome measures

Outcome measures
Measure	High_Risk_Rhabdomyosarcoma n=102 Participants Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients
Number of Patients With Complete or Partial Response Assessed by RECIST Criteria	63 percentage of participants

PRIMARY outcome

Timeframe: From enrollment to up to 2 years

Population: Percentage of patients experiencing a grade 3/4/5 toxicity in a course.

Adverse events are reported for patients receiving concurrent irinotecan hydrochloride and radiotherapy.

Outcome measures

Outcome measures
Measure	High_Risk_Rhabdomyosarcoma n=109 Participants Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients
Percentage of Patients Experiencing Adverse Events Due to Concurrent Therapy Course 1	53.3 percentage of patients Interval 43.4 to 63.0
Percentage of Patients Experiencing Adverse Events Due to Concurrent Therapy Course 2	68.4 percentage of patients Interval 58.2 to 77.4
Percentage of Patients Experiencing Adverse Events Due to Concurrent Therapy Course 3	79.3 percentage of patients Interval 69.3 to 87.3
Percentage of Patients Experiencing Adverse Events Due to Concurrent Therapy Course 4	55.7 percentage of patients Interval 43.3 to 67.6

SECONDARY outcome

Timeframe: 4 years

Population: All eligible patients

Event-free survival: Time to recurrence, second malignancy, or death as a first event, estimated from a Kaplan Meier curve

Outcome measures

Outcome measures
Measure	High_Risk_Rhabdomyosarcoma n=109 Participants Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients
Percentage of Patients Event Free at 4 Years Following Study Entry	36 Percentage of patients Interval 27.0 to 46.0

Adverse Events

High_Risk_Rhabdomyosarcoma

Serious events: 4 serious events

Other events: 95 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	High_Risk_Rhabdomyosarcoma n=108 participants at risk Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.
Infections and infestations Anorectal infection	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Infections and infestations Infections and infestations - Other	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Injury, poisoning and procedural complications Radiation recall reaction (dermatologic)	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Infections and infestations Sepsis	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.

Other adverse events

Other adverse events
Measure	High_Risk_Rhabdomyosarcoma n=108 participants at risk Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.
Gastrointestinal disorders Abdominal distension	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Infections and infestations Abdominal infection	1.9% 2/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Gastrointestinal disorders Abdominal pain	13.9% 15/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Metabolism and nutrition disorders Acidosis	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Investigations Activated partial thromboplastin time prolonged	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Renal and urinary disorders Acute kidney injury	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Investigations Alanine aminotransferase increased	11.1% 12/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Metabolism and nutrition disorders Alkalosis	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Gastrointestinal disorders Anal pain	2.8% 3/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Immune system disorders Anaphylaxis	2.8% 3/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Blood and lymphatic system disorders Anemia	7.4% 8/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Infections and infestations Anorectal infection	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Metabolism and nutrition disorders Anorexia	22.2% 24/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Gastrointestinal disorders Ascites	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Investigations Aspartate aminotransferase increased	7.4% 8/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Musculoskeletal and connective tissue disorders Back pain	3.7% 4/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Infections and infestations Bladder infection	2.8% 3/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Investigations Blood antidiuretic hormone abnormal	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Investigations Blood bilirubin increased	3.7% 4/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Musculoskeletal and connective tissue disorders Bone pain	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Musculoskeletal and connective tissue disorders Buttock pain	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Cardiac disorders Cardiac disorders - other	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Infections and infestations Catheter related infection	7.4% 8/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Renal and urinary disorders Chronic kidney disease	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Nervous system disorders Cognitive disturbance	1.9% 2/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Gastrointestinal disorders Colitis	8.3% 9/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Gastrointestinal disorders Constipation	3.7% 4/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Respiratory, thoracic and mediastinal disorders Cough	1.9% 2/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Investigations Creatinine increased	1.9% 2/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Renal and urinary disorders Cystitis noninfective	2.8% 3/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Metabolism and nutrition disorders Dehydration	15.7% 17/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Psychiatric disorders Depression	3.7% 4/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Injury, poisoning and procedural complications Dermatitis radiation	5.6% 6/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Gastrointestinal disorders Diarrhea	31.5% 34/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Gastrointestinal disorders Dysphagia	2.8% 3/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
General disorders Edema limbs	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Nervous system disorders Encephalopathy	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Gastrointestinal disorders Enterocolitis	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Infections and infestations Enterocolitis infectious	10.2% 11/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.9% 2/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Gastrointestinal disorders Esophageal pain	1.9% 2/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Gastrointestinal disorders Esophageal stenosis	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Gastrointestinal disorders Esophagitis	3.7% 4/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
General disorders Fatigue	6.5% 7/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Blood and lymphatic system disorders Febrile neutropenia	40.7% 44/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
General disorders Fever	3.7% 4/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
General disorders Gait disturbance	1.9% 2/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Gastrointestinal disorders Gastritis	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Gastrointestinal disorders Gastrointestinal disorders - Other	1.9% 2/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
General disorders General disorders and administration site conditions - Other	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Investigations GGT increased	2.8% 3/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Nervous system disorders Headache	4.6% 5/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Renal and urinary disorders Hematuria	1.9% 2/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Hepatobiliary disorders Hepatic failure	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Metabolism and nutrition disorders Hypercalcemia	2.8% 3/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Metabolism and nutrition disorders Hyperglycemia	7.4% 8/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Metabolism and nutrition disorders Hyperkalemia	2.8% 3/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Metabolism and nutrition disorders Hypernatremia	1.9% 2/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Metabolism and nutrition disorders Hyperuricemia	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Metabolism and nutrition disorders Hypoalbuminemia	4.6% 5/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Metabolism and nutrition disorders Hypocalcemia	4.6% 5/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Metabolism and nutrition disorders Hypoglycemia	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Metabolism and nutrition disorders Hypokalemia	18.5% 20/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Metabolism and nutrition disorders Hyponatremia	6.5% 7/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Metabolism and nutrition disorders Hypophosphatemia	4.6% 5/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Vascular disorders Hypotension	2.8% 3/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Respiratory, thoracic and mediastinal disorders Hypoxia	4.6% 5/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Gastrointestinal disorders Ileus	2.8% 3/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Infections and infestations Infections and infestations - Other	47.2% 51/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Investigations INR increased	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Respiratory, thoracic and mediastinal disorders Laryngeal edema	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Investigations Lipase increased	3.7% 4/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Infections and infestations Lung infection	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Investigations Lymphocyte count decreased	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Gastrointestinal disorders Malabsorption	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Gastrointestinal disorders Mucositis oral	18.5% 20/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	1.9% 2/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Musculoskeletal and connective tissue disorders Myalgia	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Infections and infestations Nail infection	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Gastrointestinal disorders Nausea	19.4% 21/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Musculoskeletal and connective tissue disorders Neck pain	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Nervous system disorders Nervous system disorders - Other	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Nervous system disorders Neuralgia	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Investigations Neutrophil count decreased	8.3% 9/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
General disorders Non-cardiac chest pain	1.9% 2/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Gastrointestinal disorders Oral pain	3.7% 4/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Infections and infestations Otitis externa	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Infections and infestations Otitis media	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
General disorders Pain	3.7% 4/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Musculoskeletal and connective tissue disorders Pain in extremity	1.9% 2/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Cardiac disorders Pericardial effusion	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Reproductive system and breast disorders Perineal pain	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Nervous system disorders Peripheral motor neuropathy	7.4% 8/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Infections and infestations Peripheral nerve infection	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Nervous system disorders Peripheral sensory neuropathy	7.4% 8/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Psychiatric disorders Personality change	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	2.8% 3/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Investigations Platelet count decreased	3.7% 4/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.9% 2/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Infections and infestations Pleural infection	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.7% 4/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Gastrointestinal disorders Proctitis	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Renal and urinary disorders Proteinuria	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Skin and subcutaneous tissue disorders Purpura	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Injury, poisoning and procedural complications Radiation recall reaction (dermatologic)	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Gastrointestinal disorders Rectal mucositis	1.9% 2/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Gastrointestinal disorders Rectal pain	1.9% 2/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Renal and urinary disorders Renal and urinary disorders - Other	1.9% 2/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Nervous system disorders Seizure	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Investigations Serum amylase increased	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Nervous system disorders Sinus pain	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Infections and infestations Skin infection	1.9% 2/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Gastrointestinal disorders Small intestinal obstruction	1.9% 2/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Gastrointestinal disorders Stomach pain	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Cardiac disorders Supraventricular tachycardia	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Nervous system disorders Syncope	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Vascular disorders Thromboembolic event	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Infections and infestations Tooth infection	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Gastrointestinal disorders Typhlitis	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Infections and infestations Upper respiratory infection	3.7% 4/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Infections and infestations Urinary tract infection	3.7% 4/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Renal and urinary disorders Urinary tract obstruction	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Renal and urinary disorders Urinary tract pain	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Reproductive system and breast disorders Uterine hemorrhage	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Injury, poisoning and procedural complications Vascular access complication	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Vascular disorders Vascular disorders - Other	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Injury, poisoning and procedural complications Venous injury	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Gastrointestinal disorders Vomiting	14.8% 16/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Investigations Weight loss	13.0% 14/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Investigations White blood cell decreased	3.7% 4/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Infections and infestations Wound infection	0.93% 1/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor Pain	3.7% 4/108 The denominator for adverse events is 108 rather than 109 is because 1 patient did not receive treatment, therefore was excluded from the denominator.

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 626-447-0064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place