Trial Outcomes & Findings for Two Regimens of Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed Localized Ewing Sarcoma Family of Tumors (NCT NCT00618813)

Last Updated: 2014-09-25

Results Overview

Incidence of death from complications of therapy while the patient is on protocol therapy or within one month of terminating protocol therapy

Recruitment status

COMPLETED

Study phase

Target enrollment

35 participants

Primary outcome timeframe

Length of protocol therapy (up to 37 weeks) plus 30 days

Results posted on

2014-09-25

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Combination Chemotherapy) See Detailed Description radiation therapy: Undergo radiation therapy therapeutic conventional surgery: Undergo surgery etoposide: Given IV ifosfamide: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV topotecan hydrochloride: Given IV filgrastim: Given SC
Overall Study STARTED	35
Overall Study Completed Enrollment - Week 12 Treatment	35
Overall Study Completed Week 13 to Week 22 Treatment	34
Overall Study Completed Week 23 to Week 28 Therapy	34
Overall Study Completed Week 29 to Week 37 Therapy	33
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Combination Chemotherapy) See Detailed Description radiation therapy: Undergo radiation therapy therapeutic conventional surgery: Undergo surgery etoposide: Given IV ifosfamide: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV topotecan hydrochloride: Given IV filgrastim: Given SC
Overall Study Lack of Efficacy	1
Overall Study Physician Decision	2
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Two Regimens of Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed Localized Ewing Sarcoma Family of Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Combination Chemotherapy) n=35 Participants See Detailed Description radiation therapy: Undergo radiation therapy therapeutic conventional surgery: Undergo surgery etoposide: Given IV ifosfamide: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV topotecan hydrochloride: Given IV filgrastim: Given SC
Age, Continuous	11 years n=39 Participants
Sex: Female, Male Female	16 Participants n=39 Participants
Sex: Female, Male Male	19 Participants n=39 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=39 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=39 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants
Race (NIH/OMB) Black or African American	0 Participants n=39 Participants
Race (NIH/OMB) White	29 Participants n=39 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=39 Participants
Region of Enrollment United States	33 participants n=39 Participants
Region of Enrollment Canada	1 participants n=39 Participants
Region of Enrollment Australia	1 participants n=39 Participants

PRIMARY outcome

Timeframe: Length of protocol therapy (up to 37 weeks) plus 30 days

Population: Any patient who receives at least one cycle of protocol therapy, or who dies as a result of complications of therapy prior to completing one cycle of therapy will be evaluable for this outcome

Incidence of death from complications of therapy while the patient is on protocol therapy or within one month of terminating protocol therapy

Outcome measures

Outcome measures
Measure	Treatment (Combination Chemotherapy) n=35 Participants See Detailed Description radiation therapy: Undergo radiation therapy therapeutic conventional surgery: Undergo surgery etoposide: Given IV ifosfamide: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV topotecan hydrochloride: Given IV filgrastim: Given SC
Incidence of Death	0 participants

PRIMARY outcome

Timeframe: Enrollment to week 12

Population: Any patient who receives at least one cycle of protocol therapy, or who is removed from protocol therapy partly or solely because of a dose-limiting toxicity will be evaluable for this outcome.

The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks.

Outcome measures

Outcome measures
Measure	Treatment (Combination Chemotherapy) n=35 Participants See Detailed Description radiation therapy: Undergo radiation therapy therapeutic conventional surgery: Undergo surgery etoposide: Given IV ifosfamide: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV topotecan hydrochloride: Given IV filgrastim: Given SC
Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Enrollment to Week 12	12 participants

PRIMARY outcome

Timeframe: Week 13 to week 22

Population: One patient was not evaluated for dose-limiting toxicity during weeks 13-22 because patient did not complete that segment of protocol therapy.

Outcome measures

Outcome measures
Measure	Treatment (Combination Chemotherapy) n=34 Participants See Detailed Description radiation therapy: Undergo radiation therapy therapeutic conventional surgery: Undergo surgery etoposide: Given IV ifosfamide: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV topotecan hydrochloride: Given IV filgrastim: Given SC
Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 13 to Week 22	9 participants

PRIMARY outcome

Timeframe: Week 23 to week 28

Population: One patient was not evaluated for DLT during weeks 23-28 because the patient did not complete that segment of therapy.

Outcome measures

Outcome measures
Measure	Treatment (Combination Chemotherapy) n=34 Participants See Detailed Description radiation therapy: Undergo radiation therapy therapeutic conventional surgery: Undergo surgery etoposide: Given IV ifosfamide: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV topotecan hydrochloride: Given IV filgrastim: Given SC
Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 23 to Week 28	9 participants

PRIMARY outcome

Timeframe: Week 29 to week 37

Population: Two patients were not evaluated for DLT during weeks 29-37 because those patients did not complete that segment of protocol therapy.

Outcome measures

Outcome measures
Measure	Treatment (Combination Chemotherapy) n=33 Participants See Detailed Description radiation therapy: Undergo radiation therapy therapeutic conventional surgery: Undergo surgery etoposide: Given IV ifosfamide: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV topotecan hydrochloride: Given IV filgrastim: Given SC
Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 29 to Week 37	14 participants

SECONDARY outcome

Timeframe: From enrollment to event or 10 years from enrollment, whichever occurs first

Disease progression, occurrence of a second malignant neoplasm (SMN)or death will be considered an analytic event. In all other cases, the patient will be considered censored at last contact.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Combination Chemotherapy)

Serious events: 2 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Combination Chemotherapy) n=35 participants at risk See Detailed Description radiation therapy: Undergo radiation therapy therapeutic conventional surgery: Undergo surgery etoposide: Given IV ifosfamide: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV topotecan hydrochloride: Given IV filgrastim: Given SC
Blood and lymphatic system disorders Anemia	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Respiratory, thoracic and mediastinal disorders Apnea	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Investigations Platelet count decreased	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.

Other adverse events

Other adverse events
Measure	Treatment (Combination Chemotherapy) n=35 participants at risk See Detailed Description radiation therapy: Undergo radiation therapy therapeutic conventional surgery: Undergo surgery etoposide: Given IV ifosfamide: Given IV doxorubicin hydrochloride: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV topotecan hydrochloride: Given IV filgrastim: Given SC
Gastrointestinal disorders Abdominal pain	11.4% 4/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Investigations Alanine aminotransferase increased	17.1% 6/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Blood and lymphatic system disorders Anemia	71.4% 25/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Infections and infestations Anorectal infection	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Metabolism and nutrition disorders Anorexia	8.6% 3/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Psychiatric disorders Anxiety	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Respiratory, thoracic and mediastinal disorders Apnea	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Infections and infestations Appendicitis	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Investigations Aspartate aminotransferase increased	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Musculoskeletal and connective tissue disorders Back pain	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Infections and infestations Bladder infection	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Investigations Blood bilirubin increased	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Gastrointestinal disorders Constipation	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Metabolism and nutrition disorders Dehydration	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Psychiatric disorders Depression	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Injury, poisoning and procedural complications Dermatitis radiation	5.7% 2/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Gastrointestinal disorders Diarrhea	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Gastrointestinal disorders Dysphagia	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Nervous system disorders Encephalopathy	5.7% 2/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Infections and infestations Enterocolitis infectious	5.7% 2/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Gastrointestinal disorders Esophagitis	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Blood and lymphatic system disorders Febrile neutropenia	48.6% 17/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
General disorders Fever	5.7% 2/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Hepatobiliary disorders Gallbladder obstruction	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Nervous system disorders Headache	5.7% 2/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Metabolism and nutrition disorders Hyperglycemia	11.4% 4/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Metabolism and nutrition disorders Hypocalcemia	5.7% 2/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Metabolism and nutrition disorders Hypokalemia	25.7% 9/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Metabolism and nutrition disorders Hypomagnesemia	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Metabolism and nutrition disorders Hyponatremia	8.6% 3/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Metabolism and nutrition disorders Hypophosphatemia	11.4% 4/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Infections and infestations Infections and infestations - Other	51.4% 18/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Injury, poisoning and procedural complications Intraoperative arterial injury	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Injury, poisoning and procedural complications Intraoperative neurological injury	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Infections and infestations Lung infection	5.7% 2/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Investigations Lymphocyte count decreased	34.3% 12/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Gastrointestinal disorders Mucositis oral	5.7% 2/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Gastrointestinal disorders Nausea	5.7% 2/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Investigations Neutrophil count decreased	77.1% 27/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
General disorders Pain	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Musculoskeletal and connective tissue disorders Pain in extremity	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Reproductive system and breast disorders Perineal pain	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Nervous system disorders Peripheral motor neuropathy	8.6% 3/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Nervous system disorders Peripheral sensory neuropathy	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Investigations Platelet count decreased	77.1% 27/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Gastrointestinal disorders Rectal pain	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Infections and infestations Tracheitis	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Gastrointestinal disorders Typhlitis	5.7% 2/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Renal and urinary disorders Urinary retention	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Infections and infestations Urinary tract infection	8.6% 3/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Gastrointestinal disorders Vomiting	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Investigations Weight loss	2.9% 1/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.
Investigations White blood cell decreased	74.3% 26/35 One patient was not evaluated for DLT during weeks 13-22 and 23-28 because patient did not complete that segment of therapy. Two patients were not evaluated for DLT during weeks 29-37 because they did not complete that segment of therapy.

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 352-273-0558

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Must obtain prior Sponsor approval.
Publication restrictions are in place

Restriction type: OTHER