Trial Outcomes & Findings for Cisplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer (NCT NCT00066222)

Last Updated: 2017-12-22

Results Overview

Survival time is defined as time from study registration to the date of death from any cause and survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

72 participants

Primary outcome timeframe

From registration to 2 years

Results posted on

2017-12-22

Participant Flow

Participant milestones

Participant milestones
Measure	Radiation Therapy + Chemotherapy Accelerated high dose thoracic radiation therapy (RT) with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
Overall Study STARTED	72
Overall Study COMPLETED	71
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Radiation Therapy + Chemotherapy Accelerated high dose thoracic radiation therapy (RT) with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
Overall Study No protocol treatment received	1

Baseline Characteristics

Cisplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiation Therapy + Chemotherapy n=71 Participants Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
Age, Continuous	71 years n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: From registration to 2 years

Population: All eligible patients who started study treatment.

Outcome measures

Outcome measures
Measure	Radiation Therapy + Chemotherapy n=71 Participants Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
Overall Survival at 2 Years	36.60 percentage of participants Interval 25.6 to 47.7

SECONDARY outcome

Timeframe: From registration to one year.

Population: Eligible patients who started study treatment

An event for overall survival is death due to any cause. Overall survival time is defined as time from study registration to the date of death from any cause. An event for progression-free survival is the first of the following: local progression, regional progression, distant metastases, or death due to any cause. Progression-free survival time is defined as time from study registration to the date of first failure. For both outcome measures, patients last known to be alive without failure are censored at the date of last contact. Survival rates are estimated by the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Radiation Therapy + Chemotherapy n=71 Participants Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
Overall Survival (OS) and Progression-free Survival (PFS) at 1 Year Overall Survival	77.5 percentage of participants Interval 65.9 to 85.5
Overall Survival (OS) and Progression-free Survival (PFS) at 1 Year Progression-free Survival	42.3 percentage of participants Interval 30.7 to 53.4

SECONDARY outcome

Timeframe: From registration to 2 years

Population: All eligible patients who started study treatment

Outcome measures

Outcome measures
Measure	Radiation Therapy + Chemotherapy n=71 Participants Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
Median Overall Survival Time and Progression-free Survival Time Overall Survival	19.0 months Interval 16.7 to 21.7
Median Overall Survival Time and Progression-free Survival Time Progression-free Survival	9.9 months Interval 7.9 to 12.4

SECONDARY outcome

Timeframe: From start of radiation therapy until 90 days following the start of radiation therapy

Population: Eligible patients who started study treatment

Highest grade treatment-related toxicity per subject was counted. Toxicities were graded using Common Toxicity Criteria (CTC) v 2.0. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening or disabling, Grade 5= Death related to toxicity.

Outcome measures

Outcome measures
Measure	Radiation Therapy + Chemotherapy n=71 Participants Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
Number of Patients With Acute Treatment-related Grade 3 or 4 Esophagitis	13 Participants

SECONDARY outcome

Timeframe: From the start of treatment to 2 years

Population: Eligible patients who started study treatment

A treatment-related fatality was any death judged to be related to protocol treatment.

Outcome measures

Outcome measures
Measure	Radiation Therapy + Chemotherapy n=71 Participants Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
Frequency of Treatment-related Fatalities at 2 Years	2 Participants

SECONDARY outcome

Timeframe: From the start of treatment to 2 months following the completion of chemotherapy

Population: Eligible patients who started study treatment and were observed for at least 2 months post-treatment

Response will be recorded as the best response observed two months after the completion of chemoradiation therapy. Tumor response as defined by Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions as measured by MRI, CT, or physical examination (this is the order of preference for measurement). Partial Response (PR): \>= 30% decrease in the sum of the longest diameter (LD) of target lesions (order of preference for measurement is MRI, CT, physical examination). Progressive Disease (PD): \>= 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions (order of preference for measurement is MRI, CT, physical examination). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Outcome measures

Outcome measures
Measure	Radiation Therapy + Chemotherapy n=68 Participants Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
Tumor Response Complete Response	29 Participants
Tumor Response Partial Response	28 Participants
Tumor Response Stable Disease	7 Participants
Tumor Response Progressive Disease	4 Participants

Adverse Events

Radiation Therapy + Chemotherapy

Serious events: 67 serious events

Other events: 71 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Radiation Therapy + Chemotherapy n=71 participants at risk Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
Blood and lymphatic system disorders Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe	19.7% 14/71 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).
Blood and lymphatic system disorders Hematologic-Other	1.4% 1/71 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).
Blood and lymphatic system disorders Hemoglobin (Hgb)	25.4% 18/71 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).
Blood and lymphatic system disorders Hemoglobin (Hgb) for leukemia	1.4% 1/71 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).
Blood and lymphatic system disorders Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis, other)	1.4% 1/71 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).
Blood and lymphatic system disorders Thrombotic microangiopathy for BMT (e.g., thrombotic thrombocytopenic purpura/TTP or hemolytic urem	1.4% 1/71 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).
Blood and lymphatic system disorders Transfusion: Platelets	2.8% 2/71 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).
Blood and lymphatic system disorders Transfusion: pRBCs	2.8% 2/71 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).
Cardiac disorders Arrhythmia- other	1.4% 1/71 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).
Cardiac disorders Circulatory or cardiac-Other	1.4% 1/71 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).
Cardiac disorders Late RT Toxicity: Heart: NOS	1.4% 1/71 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).
Cardiac disorders Pericardial effusion/pericarditis	1.4% 1/71 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).
Cardiac disorders Sinus tachycardia	1.4% 1/71 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).
Gastrointestinal disorders Colitis	1.4% 1/71 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).
Gastrointestinal disorders Diarrhea (without colostomy)	2.8% 2/71 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).
Gastrointestinal disorders Dysphagia, esophagitis, odynophagia (painful swallowing)	9.9% 7/71 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).
Gastrointestinal disorders Dysphagia-esophageal related to radiation	8.5% 6/71 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).
Gastrointestinal disorders GI-Other	1.4% 1/71 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).
Gastrointestinal disorders Mucositis due to radiation	1.4% 1/71 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).
Gastrointestinal disorders Nausea	19.7% 14/71 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).
Gastrointestinal disorders Stomatitis/pharyngitis (oral/pharyngeal mucositis)	1.4% 1/71 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).
Gastrointestinal disorders Vomiting	16.9% 12/71 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).
General disorders Fatigue (lethargy, malaise, asthenia)	1.4% 1/71 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).
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 109/L)	1.4% 1/71 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).
General disorders Pain-Other	5.6% 4/71 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).
Hepatobiliary disorders Hepatic-Other	1.4% 1/71 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).
Immune system disorders Allergic reaction/hypersensitivity (including drug fever)	1.4% 1/71 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).
Infections and infestations Infection with grade 3 or 4 neutropenia	9.9% 7/71 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).
Infections and infestations Infection with unknown ANC	1.4% 1/71 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).
Infections and infestations Infection without neutropenia	4.2% 3/71 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).
Infections and infestations Infection, Other	1.4% 1/71 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).
Infections and infestations Wound-infectious	1.4% 1/71 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).
Injury, poisoning and procedural complications Operative injury of vein/artery	1.4% 1/71 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).
Investigations Bilirubin	1.4% 1/71 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).
Investigations Cardiac troponin T (cTnT)	1.4% 1/71 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).
Investigations Creatinine	4.2% 3/71 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).
Investigations Leukocytes (total WBC)	74.6% 53/71 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).
Investigations Lymphopenia	9.9% 7/71 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).
Investigations Neutrophils/granulocytes (ANC/AGC)	78.9% 56/71 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).
Investigations Platelets	5.6% 4/71 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).
Investigations SIADH (syndrome of inappropriate anti-diuretic hormone)	1.4% 1/71 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).
Investigations Weight loss	1.4% 1/71 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).
Metabolism and nutrition disorders Anorexia	5.6% 4/71 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).
Metabolism and nutrition disorders Dehydration	11.3% 8/71 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).
Metabolism and nutrition disorders Hyperglycemia	4.2% 3/71 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).
Metabolism and nutrition disorders Hyperkalemia	1.4% 1/71 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).
Metabolism and nutrition disorders Hypernatremia	4.2% 3/71 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).
Metabolism and nutrition disorders Hypocalcemia	2.8% 2/71 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).
Metabolism and nutrition disorders Hypokalemia	11.3% 8/71 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).
Metabolism and nutrition disorders Hypomagnesmia	2.8% 2/71 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).
Metabolism and nutrition disorders Hyponatremia	12.7% 9/71 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).
Nervous system disorders CNS cerebrovascular ischemia	1.4% 1/71 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).
Nervous system disorders Depressed level of consciousness	1.4% 1/71 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).
Nervous system disorders Memory loss	1.4% 1/71 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).
Nervous system disorders Neuropathic pain (e.g., jaw pain, neurologic pain, phantom limb pain, post-infectious neuralgia, or	4.2% 3/71 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).
Nervous system disorders Neuropathy motor	1.4% 1/71 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).
Nervous system disorders Neuropathy-sensory	2.8% 2/71 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).
Nervous system disorders Seizure(s)	1.4% 1/71 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).
Nervous system disorders Syncope	1.4% 1/71 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).
Renal and urinary disorders Incontinence	1.4% 1/71 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).
Renal and urinary disorders Renal failure	5.6% 4/71 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).
Respiratory, thoracic and mediastinal disorders Apnea	1.4% 1/71 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).
Respiratory, thoracic and mediastinal disorders Cough	2.8% 2/71 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).
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	7.0% 5/71 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).
Respiratory, thoracic and mediastinal disorders Late RT Toxicity: Lung: NOS	1.4% 1/71 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).
Respiratory, thoracic and mediastinal disorders Pleuritic pain	1.4% 1/71 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).
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	1.4% 1/71 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).
Respiratory, thoracic and mediastinal disorders Pulmonary-Other	4.2% 3/71 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).
Vascular disorders Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia	1.4% 1/71 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).
Vascular disorders Hypotension	4.2% 3/71 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).
Vascular disorders Peripheral arterial ischemia	1.4% 1/71 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).
Vascular disorders Thrombosis/embolism	5.6% 4/71 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).

Other adverse events

Other adverse events
Measure	Radiation Therapy + Chemotherapy n=71 participants at risk Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
Blood and lymphatic system disorders Hematologic-Other	7.0% 5/71 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).
Blood and lymphatic system disorders Hemoglobin (Hgb)	67.6% 48/71 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).
Cardiac disorders Edema	7.0% 5/71 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).
Gastrointestinal disorders Constipation	23.9% 17/71 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).
Gastrointestinal disorders Diarrhea (without colostomy)	15.5% 11/71 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).
Gastrointestinal disorders Dyspepsia/heartburn	8.5% 6/71 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).
Gastrointestinal disorders Dysphagia, esophagitis, odynophagia (painful swallowing)	35.2% 25/71 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).
Gastrointestinal disorders Dysphagia-esophageal related to radiation	33.8% 24/71 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).
Gastrointestinal disorders Dysphagia-pharyngeal related to radiation	5.6% 4/71 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).
Gastrointestinal disorders GI-Other	8.5% 6/71 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).
Gastrointestinal disorders Late RT Toxicity: Esophagus: NOS	18.3% 13/71 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).
Gastrointestinal disorders Nausea	53.5% 38/71 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).
Gastrointestinal disorders Stomatitis/pharyngitis (oral/pharyngeal mucositis)	8.5% 6/71 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).
Gastrointestinal disorders Vomiting	33.8% 24/71 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).
General disorders Chest pain (non-cardiac and non-pleuritic)	7.0% 5/71 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).
General disorders Fatigue (lethargy, malaise, asthenia)	77.5% 55/71 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).
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 109/L)	8.5% 6/71 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).
General disorders Late RT Toxicity: Other: NOS	23.9% 17/71 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).
General disorders Pain due to radiation	12.7% 9/71 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).
General disorders Pain-Other	15.5% 11/71 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).
Injury, poisoning and procedural complications Late RT Toxicity: Skin: NOS	9.9% 7/71 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).
Injury, poisoning and procedural complications Radiation dermatitis	25.4% 18/71 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).
Investigations Alkaline phosphatase	5.6% 4/71 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).
Investigations Creatinine	19.7% 14/71 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).
Investigations Leukocytes (total WBC)	14.1% 10/71 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).
Investigations Lymphopenia	9.9% 7/71 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).
Investigations Neutrophils/granulocytes (ANC/AGC)	8.5% 6/71 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).
Investigations Platelets	67.6% 48/71 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).
Investigations Weight loss	28.2% 20/71 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).
Metabolism and nutrition disorders Anorexia	46.5% 33/71 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).
Metabolism and nutrition disorders Dehydration	26.8% 19/71 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).
Metabolism and nutrition disorders Hyperglycemia	16.9% 12/71 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).
Metabolism and nutrition disorders Hyperkalemia	8.5% 6/71 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).
Metabolism and nutrition disorders Hypoalbuminemia	16.9% 12/71 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).
Metabolism and nutrition disorders Hypocalcemia	16.9% 12/71 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).
Metabolism and nutrition disorders Hypokalemia	7.0% 5/71 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).
Metabolism and nutrition disorders Hypomagnesmia	23.9% 17/71 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).
Metabolism and nutrition disorders Hyponatremia	18.3% 13/71 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).
Musculoskeletal and connective tissue disorders Muscle weakness (not due to neuropathy)	8.5% 6/71 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).
Musculoskeletal and connective tissue disorders Myalgia (muscle ache)	5.6% 4/71 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).
Nervous system disorders Ataxia (incoordination)	7.0% 5/71 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).
Nervous system disorders Dizziness/lightheadedness	19.7% 14/71 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).
Nervous system disorders Headache	11.3% 8/71 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).
Nervous system disorders Memory loss	7.0% 5/71 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).
Nervous system disorders Neuropathy motor	5.6% 4/71 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).
Nervous system disorders Neuropathy-sensory	9.9% 7/71 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).
Nervous system disorders Taste disturbance (dysgeusia)	5.6% 4/71 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).
Psychiatric disorders Insomnia	8.5% 6/71 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).
Psychiatric disorders Mood alteration-depression	7.0% 5/71 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).
Respiratory, thoracic and mediastinal disorders Cough	33.8% 24/71 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).
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	23.9% 17/71 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).
Respiratory, thoracic and mediastinal disorders Late RT Toxicity: Lung: NOS	52.1% 37/71 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).
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	5.6% 4/71 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).
Skin and subcutaneous tissue disorders Alopecia	42.3% 30/71 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).
Vascular disorders Hypotension	7.0% 5/71 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).

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.
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Restriction type: OTHER