Trial Outcomes & Findings for Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction (NCT NCT00069953)

Last Updated: 2017-02-17

Results Overview

One-year survival estimate is reported. Survival time is defined as time from registration to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact. This analysis was planned to occur when all patients had been potentially followed for 1 year. On the basis of a 1-year survival rate of 60% from the Radiation Therapy Oncology Group (RTOG) esophageal database, 38 analyzable patients with a 1-year survival rate of 77.5% or better was needed for this trial to be deemed promising enough for development of a Phase III protocol (type I error of 0.05 and type II error of 0.20).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

43 participants

Primary outcome timeframe

From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 1 year.

Results posted on

2017-02-17

Participant Flow

Participant milestones

Participant milestones
Measure	ChemoRT and Selective Surgery Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
Overall Study STARTED	43
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	ChemoRT and Selective Surgery Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
Overall Study Protocol Violation	2

Baseline Characteristics

Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ChemoRT and Selective Surgery n=41 Participants Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
Age, Continuous	59 years n=5 Participants
Gender Female	7 Participants n=5 Participants
Gender Male	34 Participants n=5 Participants

PRIMARY outcome

Timeframe: From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 1 year.

Population: All eligible patients.

Outcome measures

Outcome measures
Measure	ChemoRT and Selective Surgery n=41 Participants Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
Overall Survival (1-year Rate Reported)	71 percentage of participants Interval 54.0 to 82.0

SECONDARY outcome

Timeframe: From start of chemotherapy to surgery or 2 months after chemoradiation (for patients not undergoing surgery).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Analysis occurs with the primary outcome measure.

Outcome measures

Outcome data not reported

Adverse Events

ChemoRT and Selective Surgery

Serious events: 26 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ChemoRT and Selective Surgery n=41 participants at risk Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
Blood and lymphatic system disorders Packed red blood cell transfusion	2.4% 1/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Cardiac disorders Arrhythmia NOS	2.4% 1/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Gastrointestinal disorders Diarrhea NOS	9.8% 4/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Gastrointestinal disorders Esophageal spasm	12.2% 5/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Gastrointestinal disorders Esophagitis NOS	4.9% 2/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Gastrointestinal disorders GI-other	2.4% 1/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Gastrointestinal disorders Nausea	19.5% 8/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Gastrointestinal disorders Tracheo-oesophageal fistula NOS	2.4% 1/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Gastrointestinal disorders Vomiting NOS	9.8% 4/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
General disorders Chest pain	4.9% 2/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
General disorders Pain due to radiation	7.3% 3/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
General disorders Pain-other	7.3% 3/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Infections and infestations Infection NOS	4.9% 2/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Infections and infestations Infection, Other	2.4% 1/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Investigations Neutropenia	2.4% 1/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Metabolism and nutrition disorders Anorexia	2.4% 1/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Metabolism and nutrition disorders Dehydration	7.3% 3/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Metabolism and nutrition disorders Hyperglycemia NOS	9.8% 4/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Metabolism and nutrition disorders Hyponatremia	2.4% 1/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Nervous system disorders Dizziness (exc vertigo)	2.4% 1/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Nervous system disorders Peripheral sensory neuropathy	2.4% 1/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Renal and urinary disorders Renal failure NOS	2.4% 1/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	2.4% 1/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Respiratory, thoracic and mediastinal disorders Dyspnea NOS	2.4% 1/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Respiratory, thoracic and mediastinal disorders Hypoxia	7.3% 3/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Respiratory, thoracic and mediastinal disorders Late RT Toxicity: Lung: NOS	2.4% 1/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Respiratory, thoracic and mediastinal disorders Pneumonitis NOS	7.3% 3/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Respiratory, thoracic and mediastinal disorders Pulmonary-other	4.9% 2/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Vascular disorders Thrombosis NOS	4.9% 2/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.

Other adverse events

Other adverse events
Measure	ChemoRT and Selective Surgery n=41 participants at risk Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
Blood and lymphatic system disorders Hemoglobin decreased	87.8% 36/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Gastrointestinal disorders Constipation	43.9% 18/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Gastrointestinal disorders Diarrhea NOS	39.0% 16/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Gastrointestinal disorders Dry mouth	9.8% 4/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Gastrointestinal disorders Dyspepsia	17.1% 7/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Gastrointestinal disorders Esophageal spasm	26.8% 11/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Gastrointestinal disorders Esophagitis NOS	36.6% 15/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Gastrointestinal disorders GI-other	22.0% 9/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Gastrointestinal disorders Late RT Toxicity: Esophagus: NOS	12.2% 5/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Gastrointestinal disorders Nausea	70.7% 29/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Gastrointestinal disorders Stomatitis	19.5% 8/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Gastrointestinal disorders Vomiting NOS	43.9% 18/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
General disorders Chest pain	7.3% 3/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
General disorders Fatigue	90.2% 37/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
General disorders Pain due to radiation	14.6% 6/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
General disorders Pain-other	26.8% 11/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
General disorders Pyrexia	9.8% 4/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Infections and infestations Infection NOS	9.8% 4/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Injury, poisoning and procedural complications Dermatitis radiation NOS	29.3% 12/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Investigations Alanine aminotransferase increased	9.8% 4/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Investigations Aspartate aminotransferase increased	14.6% 6/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Investigations Blood alkaline phosphatase NOS increased	22.0% 9/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Investigations Blood bilirubin increased	9.8% 4/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Investigations Blood creatinine increased	12.2% 5/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Investigations Leukopenia NOS	68.3% 28/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Investigations Lymphopenia	17.1% 7/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Investigations Metabolic-Other	7.3% 3/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Investigations Neutropenia	34.1% 14/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Investigations Platelet count decreased	58.5% 24/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Investigations Weight decreased	46.3% 19/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Metabolism and nutrition disorders Anorexia	53.7% 22/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Metabolism and nutrition disorders Blood albumin decreased	17.1% 7/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Metabolism and nutrition disorders Blood magnesium decreased	14.6% 6/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Metabolism and nutrition disorders Dehydration	17.1% 7/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Metabolism and nutrition disorders Hypercalcemia	7.3% 3/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Metabolism and nutrition disorders Hyperglycemia NOS	61.0% 25/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Metabolism and nutrition disorders Hypocalcemia	17.1% 7/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Metabolism and nutrition disorders Hypoglycaemia NOS	7.3% 3/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Metabolism and nutrition disorders Hypokalemia	19.5% 8/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Metabolism and nutrition disorders Hyponatremia	36.6% 15/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Musculoskeletal and connective tissue disorders Arthralgia	31.7% 13/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Musculoskeletal and connective tissue disorders Myalgia	34.1% 14/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Nervous system disorders Dizziness (exc vertigo)	19.5% 8/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Nervous system disorders Headache NOS	7.3% 3/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Nervous system disorders Peripheral motor neuropathy	7.3% 3/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Nervous system disorders Peripheral sensory neuropathy	56.1% 23/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Nervous system disorders Taste disturbance	22.0% 9/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Psychiatric disorders Insomnia NEC	24.4% 10/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Renal and urinary disorders Renal/GU-Other	7.3% 3/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Renal and urinary disorders Urinary frequency	9.8% 4/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Respiratory, thoracic and mediastinal disorders Cough	24.4% 10/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Respiratory, thoracic and mediastinal disorders Dysphonia	9.8% 4/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Respiratory, thoracic and mediastinal disorders Dyspnea NOS	9.8% 4/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Respiratory, thoracic and mediastinal disorders Hiccups	9.8% 4/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Skin and subcutaneous tissue disorders Alopecia	58.5% 24/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Skin and subcutaneous tissue disorders Dermatitis exfoliative NOS	22.0% 9/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Skin and subcutaneous tissue disorders Localized exfoliation	9.8% 4/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Vascular disorders Hypotension NOS	14.6% 6/41 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.

Additional Information

Wendy Seiferheld

NRG Oncology

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Publication restrictions are in place

Restriction type: OTHER