Trial Outcomes & Findings for Proton Beam Radiation Therapy and Chemotherapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Can Be Removed By Surgery (NCT NCT01076231)

NCT ID: NCT01076231

Last Updated: 2021-05-17

Results Overview

Feasibility will be based on multiple radiation planning and treatment parameters. Study will be deemed feasible if all patients are deemed feasible.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 34 participants
• Primary outcome timeframe: 90 Days
• Results posted on: 2021-05-17

Participant Flow

Participant milestones

Measure	Arm I Patients undergo proton beam radiotherapy over 5.5-7.5 weeks. Patients receive concurrent chemotherapy comprising cisplatin IV on days 1, 8, 29, and 36 and etoposide IV on days 1-5 and days 29-33.Treatment continues in the absence of disease progression or unacceptable toxicity. Beginning 4-6 weeks after completion of chemoradiotherapy, patients may undergo surgical resection or additional chemoradiotherapy. proton beam radiation therapy cisplatin: Given IV etoposide: Given IV therapeutic conventional surgery
Overall Study STARTED	34
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	34

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Proton Beam Radiation Therapy and Chemotherapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Can Be Removed By Surgery

Baseline characteristics by cohort

Measure	Arm I n=34 Participants Patients undergo proton beam radiotherapy over 5.5-7.5 weeks. Patients receive concurrent chemotherapy comprising cisplatin IV on days 1, 8, 29, and 36 and etoposide IV on days 1-5 and days 29-33.Treatment continues in the absence of disease progression or unacceptable toxicity. Beginning 4-6 weeks after completion of chemoradiotherapy, patients may undergo surgical resection or additional chemoradiotherapy. proton beam radiation therapy cisplatin: Given IV etoposide: Given IV therapeutic conventional surgery
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants
Age, Continuous	64.88 years STANDARD_DEVIATION 9.73 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 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	2 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants

PRIMARY outcome

Timeframe: 90 Days

Feasibility will be based on multiple radiation planning and treatment parameters. Study will be deemed feasible if all patients are deemed feasible.

Outcome measures

Measure

Arm I n=21 Participants Patients undergo proton beam radiotherapy over 5.5-7.5 weeks. Patients receive concurrent chemotherapy comprising cisplatin IV on days 1, 8, 29, and 36 and etoposide IV on days 1-5 and days 29-33.Treatment continues in the absence of disease progression or unacceptable toxicity. Beginning 4-6 weeks after completion of chemoradiotherapy, patients may undergo surgical resection or additional chemoradiotherapy. proton beam radiation therapy cisplatin: Given IV etoposide: Given IV therapeutic conventional surgery

Number of Participants Deemed Feasible to Receive Intervention

21 Participants

PRIMARY outcome

Timeframe: 90 Days

Population: 19 patients underwent surgery

DLT is defined as post-operative mortality (within 30 days of surgery) or any grade 3 or higher pneumonitis or any other grade 4 or higher toxicity which occurs during chemoradiation or within 90 days following the end of treatment, whichever is longer.

Outcome measures

Measure

Arm I n=19 Participants Patients undergo proton beam radiotherapy over 5.5-7.5 weeks. Patients receive concurrent chemotherapy comprising cisplatin IV on days 1, 8, 29, and 36 and etoposide IV on days 1-5 and days 29-33.Treatment continues in the absence of disease progression or unacceptable toxicity. Beginning 4-6 weeks after completion of chemoradiotherapy, patients may undergo surgical resection or additional chemoradiotherapy. proton beam radiation therapy cisplatin: Given IV etoposide: Given IV therapeutic conventional surgery

Dose-limiting Toxicity

0 Participants

PRIMARY outcome

Timeframe: 4.5 Years

Population: 19 patients underwent surgery

Late toxicity is defined as any grade 3 or higher pneumonitis or any grade 4 or higher toxicity which occurs more than 90 days after surgery or completion of treatment.

Outcome measures

Measure

Arm I n=19 Participants Patients undergo proton beam radiotherapy over 5.5-7.5 weeks. Patients receive concurrent chemotherapy comprising cisplatin IV on days 1, 8, 29, and 36 and etoposide IV on days 1-5 and days 29-33.Treatment continues in the absence of disease progression or unacceptable toxicity. Beginning 4-6 weeks after completion of chemoradiotherapy, patients may undergo surgical resection or additional chemoradiotherapy. proton beam radiation therapy cisplatin: Given IV etoposide: Given IV therapeutic conventional surgery

Late Toxicity

0 Participants

SECONDARY outcome

Timeframe: 90 days

Population: 19 patients underwent surgery

Pathologic CR rate is defined as the fraction of patients who undergo surgery and have no evidence of disease based on surgical pathology.

Outcome measures

Measure

Arm I n=19 Participants Patients undergo proton beam radiotherapy over 5.5-7.5 weeks. Patients receive concurrent chemotherapy comprising cisplatin IV on days 1, 8, 29, and 36 and etoposide IV on days 1-5 and days 29-33.Treatment continues in the absence of disease progression or unacceptable toxicity. Beginning 4-6 weeks after completion of chemoradiotherapy, patients may undergo surgical resection or additional chemoradiotherapy. proton beam radiation therapy cisplatin: Given IV etoposide: Given IV therapeutic conventional surgery

Pathologic CR Rate

21 complete response rate percentage

Adverse Events

Arm I

Serious events: 7 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm I n=34 participants at risk Patients undergo proton beam radiotherapy over 5.5-7.5 weeks. Patients receive concurrent chemotherapy comprising cisplatin IV on days 1, 8, 29, and 36 and etoposide IV on days 1-5 and days 29-33.Treatment continues in the absence of disease progression or unacceptable toxicity. Beginning 4-6 weeks after completion of chemoradiotherapy, patients may undergo surgical resection or additional chemoradiotherapy. proton beam radiation therapy cisplatin: Given IV etoposide: Given IV therapeutic conventional surgery
Metabolism and nutrition disorders	14.7% 5/34 • 90 days
Investigations Lymphocyte count decreased	2.9% 1/34 • 90 days
Investigations White blood cell decreased	2.9% 1/34 • 90 days

Other adverse events

Measure	Arm I n=34 participants at risk Patients undergo proton beam radiotherapy over 5.5-7.5 weeks. Patients receive concurrent chemotherapy comprising cisplatin IV on days 1, 8, 29, and 36 and etoposide IV on days 1-5 and days 29-33.Treatment continues in the absence of disease progression or unacceptable toxicity. Beginning 4-6 weeks after completion of chemoradiotherapy, patients may undergo surgical resection or additional chemoradiotherapy. proton beam radiation therapy cisplatin: Given IV etoposide: Given IV therapeutic conventional surgery
Gastrointestinal disorders	35.3% 12/34 • 90 days
Blood and lymphatic system disorders Anemia	17.6% 6/34 • 90 days
Metabolism and nutrition disorders Anorexia	11.8% 4/34 • 90 days
Gastrointestinal disorders Constipation	26.5% 9/34 • 90 days
Injury, poisoning and procedural complications Dermatitis radiation	20.6% 7/34 • 90 days
Gastrointestinal disorders Dyspepsia	11.8% 4/34 • 90 days
Gastrointestinal disorders Dysphagia	11.8% 4/34 • 90 days
Respiratory, thoracic and mediastinal disorders Dyspnea	11.8% 4/34 • 90 days
Gastrointestinal disorders Esophageal pain	8.8% 3/34 • 90 days
Gastrointestinal disorders Esophagitis	20.6% 7/34 • 90 days
General disorders Fatigue	29.4% 10/34 • 90 days
Gastrointestinal disorders Gastroesophageal reflux disease	11.8% 4/34 • 90 days
Nervous system disorders Headache	11.8% 4/34 • 90 days
Metabolism and nutrition disorders Hyperglycemia	11.8% 4/34 • 90 days
Metabolism and nutrition disorders Hypocalcemia	8.8% 3/34 • 90 days
Metabolism and nutrition disorders Hyponatremia	14.7% 5/34 • 90 days
Psychiatric disorders Insomnia	8.8% 3/34 • 90 days
Investigations Lymphocyte count decreased	17.6% 6/34 • 90 days
Gastrointestinal disorders Nausea	14.7% 5/34 • 90 days
Investigations Platelet count decreased	14.7% 5/34 • 90 days
Investigations White blood cell decreased	17.6% 6/34 • 90 days

Additional Information

Dr. Jacob Shabason

University of Pennsylvania

Phone: 215-662-3998

Email: susan.mazzoni@uphs.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place