Trial Outcomes & Findings for Phase 2 Sequential and Concurrent Chemoradiation for Advanced Nasopharyngeal Carcinoma (NPC) (NCT NCT00896181)

Last Updated: 2021-04-06

Results Overview

Progression-free survival (PFS) means to remain alive without disease progression. Progression is defined as either the appearance of one or more new cancer lesions, or a ≥ 20% increase in the sum of the longest diameters (LD) of target cancer lesions, compared the same measurement obtained at the start of treatment. This outcome reported as the number of patients remaining alive at 2 years following chemo-radiotherapy without disease progression, a number without dispersion.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

26 participants

Primary outcome timeframe

up to 29 months (ie, 24 months post-chemoradiation)

Results posted on

2021-04-06

Participant Flow

Participant milestones

Participant milestones
Measure	Chemoradiation for Nasopharyngeal Carcinoma Induction therapy as described, consisting of docetaxel, cisplatin, and fluorouracil Concurrent chemo-radiotherapy as described, 3-dimensional radiotherapy once daily for 6.5 to 7 weeks, with cisplatin weekly. The total treatment course is up to 21 weeks.
Overall Study STARTED	26
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase 2 Sequential and Concurrent Chemoradiation for Advanced Nasopharyngeal Carcinoma (NPC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemoradiation for Nasopharyngeal Carcinoma n=26 Participants Induction therapy as described, consisting of docetaxel, cisplatin, and fluorouracil Concurrent chemo-radiotherapy as described, 3-dimensional radiotherapy once daily for 6.5 to 7 weeks, with cisplatin weekly. The total treatment course is up to 21 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	51.3 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	21 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 29 months (ie, 24 months post-chemoradiation)

Population: The outcome results are reported by baseline strata, ie, M0 (non-metastatic lesions) and M1 (metastatic lesions).

Outcome measures

Outcome measures
Measure	Chemoradiation for Nasopharyngeal Carcinoma n=26 Participants Induction therapy as described, consisting of docetaxel, cisplatin, and fluorouracil Concurrent chemo-radiotherapy as described, 3-dimensional radiotherapy once daily for 6.5 to 7 weeks, with cisplatin weekly. The total treatment course is up to 21 weeks.
Number of Participants With Progression-free Survival (PFS) at 2 Years After Chemo-radiotherapy M0 (non-metastatic lesion)	18 Participants
Number of Participants With Progression-free Survival (PFS) at 2 Years After Chemo-radiotherapy M1 (metastatic lesion)	4 Participants

PRIMARY outcome

Timeframe: up to 127 months (includes treatment period of up to 5 months)

Population: The outcome results are reported by baseline strata, ie, M0 (non-metastatic lesions) and M1 (metastatic lesions).

Progression-free survival (PFS) means to remain alive without disease progression. Progression is defined as either the appearance of one or more new cancer lesions, or a ≥ 20% increase in the sum of the longest diameters (LD) of target cancer lesions, compared the same measurement obtained at the start of treatment. This outcome reported as the median duration of PFS in months since chemo-radiotherapy, with full range.

Outcome measures

Outcome measures
Measure	Chemoradiation for Nasopharyngeal Carcinoma n=26 Participants Induction therapy as described, consisting of docetaxel, cisplatin, and fluorouracil Concurrent chemo-radiotherapy as described, 3-dimensional radiotherapy once daily for 6.5 to 7 weeks, with cisplatin weekly. The total treatment course is up to 21 weeks.
Median Progression-free Survival (PFS) M0 (non-metastatic lesion)	76 months Interval 15.0 to 122.0
Median Progression-free Survival (PFS) M1 (metastatic lesion)	33 months Interval 12.0 to 90.0

SECONDARY outcome

Timeframe: up to 127 months (includes treatment period of up to 5 months)

Population: The outcome results are reported by baseline strata, ie, M0 (non-metastatic lesions) and M1 (metastatic lesions). The per-protocol duration of treatment on study was 5 months, and the outcome is reported as OS (with full range) from that time.

Overall survival (OS) was assessed as the duration of time that study participants remained alive after chemoradiotherapy. The outcome is reported as median OS (with full range).

Outcome measures

Outcome measures
Measure	Chemoradiation for Nasopharyngeal Carcinoma n=26 Participants Induction therapy as described, consisting of docetaxel, cisplatin, and fluorouracil Concurrent chemo-radiotherapy as described, 3-dimensional radiotherapy once daily for 6.5 to 7 weeks, with cisplatin weekly. The total treatment course is up to 21 weeks.
Overall Survival (OS) M0 (non-metastatic lesion)	79 months Interval 26.0 to 122.0
Overall Survival (OS) M1 (metastatic lesion)	76 months Interval 18.0 to 101.0

SECONDARY outcome

Timeframe: 8 months

Adverse events during treatment were assessed as whether they were definitely-, probably-, or possibly-related to protocol treatment (ie, adverse reaction). The outcome is reported as the number of participants who discontinued treatment due to an adverse reaction.

Outcome measures

Outcome measures
Measure	Chemoradiation for Nasopharyngeal Carcinoma n=26 Participants Induction therapy as described, consisting of docetaxel, cisplatin, and fluorouracil Concurrent chemo-radiotherapy as described, 3-dimensional radiotherapy once daily for 6.5 to 7 weeks, with cisplatin weekly. The total treatment course is up to 21 weeks.
Number of Participants With Adverse Events Resulting in Treatment Discontinuation	1 Participants

SECONDARY outcome

Timeframe: up to 29 months (ie, 24 months post-chemoradiation)

Population: The outcome results are reported by baseline strata, ie, M0 (non-metastatic lesions) and M1 (metastatic lesions).

Participants who completed 1 cycle of docetaxel, cisplatin, and 5-fluorouracil (TPF) were evaluated for response. Response was assessed for lesions designated as target (TL) and non-target (NTL) as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). The outcome is reported as a number without dispersion. TL Criterion: * CR: Disappearance of lesions * PR: 30% decrease in the sum of the longest diameter (LD) of lesions * PD: 20% increase in the sum of the LD of lesions, or any new lesion * SD: Neither sufficient shrinkage for PR nor sufficient increase for PD NTL Criterion: * CR: Disappearance of lesions and normalization of tumor marker level * PR / SD: Persistence of one or more lesion(s) and/or maintenance of tumor marker level above the normal limits (includes "incomplete response / PR). * PD: Appearance of one or more new lesions and/or unequivocal progression of existing lesions.

Outcome measures

Outcome measures
Measure	Chemoradiation for Nasopharyngeal Carcinoma n=26 Participants Induction therapy as described, consisting of docetaxel, cisplatin, and fluorouracil Concurrent chemo-radiotherapy as described, 3-dimensional radiotherapy once daily for 6.5 to 7 weeks, with cisplatin weekly. The total treatment course is up to 21 weeks.
Number of Participants With Treatment Response SD for M0 (non-metastatic lesion)	0 Participants
Number of Participants With Treatment Response SD for M1 (metastatic lesion)	0 Participants
Number of Participants With Treatment Response PD for M1 (metastatic lesion)	0 Participants
Number of Participants With Treatment Response CR for M0 (non-metastatic lesion)	17 Participants
Number of Participants With Treatment Response PR for M0 (non-metastatic lesion)	3 Participants
Number of Participants With Treatment Response PD for M0 (non-metastatic lesion)	0 Participants
Number of Participants With Treatment Response CR for M1 (metastatic lesion)	3 Participants
Number of Participants With Treatment Response PR for M1 (metastatic lesion)	1 Participants

Adverse Events

Chemoradiation for Nasopharyngeal Carcinoma

Serious events: 5 serious events

Other events: 24 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Chemoradiation for Nasopharyngeal Carcinoma n=26 participants at risk Induction therapy as described, consisting of docetaxel, cisplatin, and fluorouracil Concurrent chemo-radiotherapy as described, 3-dimensional radiotherapy once daily for 6.5 to 7 weeks, with cisplatin weekly. The total treatment course is up to 21 weeks.
Blood and lymphatic system disorders Febrile Neutropenia	19.2% 5/26 • Number of events 6 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Blood and lymphatic system disorders Gastric Hemorrhage	3.8% 1/26 • Number of events 1 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Metabolism and nutrition disorders Hypokalemia	3.8% 1/26 • Number of events 1 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Investigations Thrombocytopenia	3.8% 1/26 • Number of events 2 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
General disorders Fatigue (asthenia)	3.8% 1/26 • Number of events 1 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Vascular disorders Thromboemobolic event	3.8% 1/26 • Number of events 1 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Gastrointestinal disorders Mucositis oral	3.8% 1/26 • Number of events 1 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Gastrointestinal disorders Nausea	3.8% 1/26 • Number of events 1 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Nervous system disorders Syncope	3.8% 1/26 • Number of events 1 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Metabolism and nutrition disorders Hyponatremia	3.8% 1/26 • Number of events 1 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Gastrointestinal disorders Vomiting	3.8% 1/26 • Number of events 1 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.

Other adverse events

Other adverse events
Measure	Chemoradiation for Nasopharyngeal Carcinoma n=26 participants at risk Induction therapy as described, consisting of docetaxel, cisplatin, and fluorouracil Concurrent chemo-radiotherapy as described, 3-dimensional radiotherapy once daily for 6.5 to 7 weeks, with cisplatin weekly. The total treatment course is up to 21 weeks.
Nervous system disorders Neuropathy	7.7% 2/26 • Number of events 6 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Ear and labyrinth disorders Hearing Impaired	7.7% 2/26 • Number of events 26 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Blood and lymphatic system disorders Neutropenia	11.5% 3/26 • Number of events 7 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Investigations Platelet Count Decreased	26.9% 7/26 • Number of events 12 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Blood and lymphatic system disorders Anemia	42.3% 11/26 • Number of events 56 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Gastrointestinal disorders Oral Mucositis	92.3% 24/26 • Number of events 96 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Gastrointestinal disorders Abdominal Distension	3.8% 1/26 • Number of events 1 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Gastrointestinal disorders Abdominal Pain	3.8% 1/26 • Number of events 1 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Gastrointestinal disorders Acid Reflux	3.8% 1/26 • Number of events 1 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Investigations Alanine Aminotransferace Increase	3.8% 1/26 • Number of events 1 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Skin and subcutaneous tissue disorders Alopecia	15.4% 4/26 • Number of events 15 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Metabolism and nutrition disorders Anorexia	15.4% 4/26 • Number of events 13 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Gastrointestinal disorders Constipation	3.8% 1/26 • Number of events 1 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Infections and infestations Infections and infestations - Other, Coronavirus	3.8% 1/26 • Number of events 1 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Metabolism and nutrition disorders Dehydration	15.4% 4/26 • Number of events 4 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Skin and subcutaneous tissue disorders Dermatitis	42.3% 11/26 • Number of events 18 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Injury, poisoning and procedural complications Dermatitis radiation	19.2% 5/26 • Number of events 7 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Gastrointestinal disorders Diarrhea	15.4% 4/26 • Number of events 4 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Nervous system disorders Dysgeusia	23.1% 6/26 • Number of events 32 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Gastrointestinal disorders Dysphagia	26.9% 7/26 • Number of events 15 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
General disorders Fatigue	38.5% 10/26 • Number of events 27 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Blood and lymphatic system disorders Febrile Neutropenia	15.4% 4/26 • Number of events 5 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Metabolism and nutrition disorders Hyperglycemia	19.2% 5/26 • Number of events 14 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Metabolism and nutrition disorders Hypoalbuminemia	19.2% 5/26 • Number of events 12 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Metabolism and nutrition disorders Hypocalcemia	11.5% 3/26 • Number of events 8 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Metabolism and nutrition disorders Hypokalemia	7.7% 2/26 • Number of events 4 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Investigations Lymphocyte count decreased	69.2% 18/26 • Number of events 114 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Musculoskeletal and connective tissue disorders Muscle Weakness	3.8% 1/26 • Number of events 1 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Gastrointestinal disorders Nausea	30.8% 8/26 • Number of events 18 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Gastrointestinal disorders Oral Pain	15.4% 4/26 • Number of events 16 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Musculoskeletal and connective tissue disorders Pain in Extremities	3.8% 1/26 • Number of events 1 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Skin and subcutaneous tissue disorders Palmar Plantar Syndrome	3.8% 1/26 • Number of events 2 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Nervous system disorders Paresthesia	3.8% 1/26 • Number of events 12 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Gastrointestinal disorders Salivary Duct Inflammation	3.8% 1/26 • Number of events 1 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Infections and infestations Skin Infection	3.8% 1/26 • Number of events 2 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Nervous system disorders Somnolence	3.8% 1/26 • Number of events 1 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Infections and infestations Infections and infestations - Other, Thrush	3.8% 1/26 • Number of events 1 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Gastrointestinal disorders Typhlitis	3.8% 1/26 • Number of events 1 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Gastrointestinal disorders Vomiting	11.5% 3/26 • Number of events 3 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Investigations Weight Loss	26.9% 7/26 • Number of events 18 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Investigations White blood cell count decreased	30.8% 8/26 • Number of events 16 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Gastrointestinal disorders Xerostomia	15.4% 4/26 • Number of events 16 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Investigations Creatinine Increased	3.8% 1/26 • Number of events 1 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Gastrointestinal disorders Colitis	3.8% 1/26 • Number of events 1 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Infections and infestations Otitis Media	3.8% 1/26 • Number of events 1 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Infections and infestations Otitis Externa	3.8% 1/26 • Number of events 1 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, skin changes	3.8% 1/26 • Number of events 1 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, skin problems	3.8% 1/26 • Number of events 1 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Infections and infestations Urinary Tract Infection	3.8% 1/26 • Number of events 1 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Skin and subcutaneous tissue disorders Urticaria	3.8% 1/26 • Number of events 1 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Metabolism and nutrition disorders Hyponatremia	3.8% 1/26 • Number of events 1 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Respiratory, thoracic and mediastinal disorders Laryngeal Inflammation	3.8% 1/26 • Number of events 1 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.
Vascular disorders Hypertension	7.7% 2/26 • Number of events 2 • Adverse events were collected for up to 104 months and All-Cause Mortality was collected up to 127 months.

Additional Information

Dr. A. Dimitrios Colevas, Professor of Medicine (Oncology)

Stanford University

Phone: 650-724-9707

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place