Trial Outcomes & Findings for Curative Effect Study of Endostatin Combined With Chemoradiotherapy to Non-small-cell Lung Cancer (NCT NCT01218594)

NCT ID: NCT01218594

Last Updated: 2012-10-17

Results Overview

Tumor response was evaluated with thoracic CT scans when CCRT was completed, in accordance with Response Evaluation Criteria in Solid Tumors Group (RECIST).

• Recruitment status: UNKNOWN
• Study phase: PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: 4 weeks after CCRT
• Results posted on: 2012-10-17

Participant Flow

Between May 2009 and January 2012, 50 patients from 5 centers were enrolled onto the study.

Two patients refused treatment after consenting for therapy and were ultimately excluded from the trial before any treatment.

Participant milestones

Measure	Endostar Plus CCRT Patients received Endostar (7.5 mg/m2/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m2) and cisplatin (65 mg/m2) on days 8 and 36, with concurrent thoracic radiation at 60\~66 Gy.
Overall Study STARTED	48
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Measure	Endostar Plus CCRT Patients received Endostar (7.5 mg/m2/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m2) and cisplatin (65 mg/m2) on days 8 and 36, with concurrent thoracic radiation at 60\~66 Gy.
Overall Study Death	1
Overall Study Withdrawal by Subject	3
Overall Study Adverse Event	2
Overall Study Physician Decision	6

Baseline Characteristics

Curative Effect Study of Endostatin Combined With Chemoradiotherapy to Non-small-cell Lung Cancer

Baseline characteristics by cohort

Measure	Endostar Plus CCRT n=48 Participants Patients received Endostar (7.5 mg/m2/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m2) and cisplatin (65 mg/m2) on days 8 and 36, with concurrent thoracic radiation at 60\~66 Gy.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Age Continuous	55 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants
Region of Enrollment China	48 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks after CCRT

Population: Response rate (RR)include complete response and partial response.

Tumor response was evaluated with thoracic CT scans when CCRT was completed, in accordance with Response Evaluation Criteria in Solid Tumors Group (RECIST).

Outcome measures

Measure	Endostar Plus CCRT n=48 Participants Patients received Endostar (7.5 mg/m2/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m2) and cisplatin (65 mg/m2) on days 8 and 36, with concurrent thoracic radiation at 60\~66 Gy.
Response Rate (RR)	37 percentage of participants

Adverse Events

Endostar Plus CCRT

Serious events: 2 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Measure	Endostar Plus CCRT n=48 participants at risk Patients received Endostar (7.5 mg/m2/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m2) and cisplatin (65 mg/m2) on days 8 and 36, with concurrent thoracic radiation at 60\~66 Gy.
Respiratory, thoracic and mediastinal disorders pneumonitis	2.1% 1/48 • Number of events 1
Respiratory, thoracic and mediastinal disorders special pneumohemothorax	2.1% 1/48 • Number of events 1

Other adverse events

Measure	Endostar Plus CCRT n=48 participants at risk Patients received Endostar (7.5 mg/m2/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m2) and cisplatin (65 mg/m2) on days 8 and 36, with concurrent thoracic radiation at 60\~66 Gy.
Blood and lymphatic system disorders Hematologic toxicity	97.9% 47/48 • Number of events 47
Skin and subcutaneous tissue disorders Dermatology	97.9% 47/48 • Number of events 47
Respiratory, thoracic and mediastinal disorders Dyspnea	10.4% 5/48 • Number of events 5
Gastrointestinal disorders Esophagitis	89.6% 43/48 • Number of events 43
Respiratory, thoracic and mediastinal disorders pneumonitis	41.7% 20/48 • Number of events 20
Gastrointestinal disorders Vomiting	39.6% 19/48 • Number of events 19

Additional Information

Ming Chen

Sun Yat-Sen University Cancer Center

Phone: 86-20-87343640

Email: chenming@sysucc.org.cn

Results disclosure agreements

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