DP-EN-RT: Curative Effect Study of Endostatin Combined With Chemoradiotherapy to Non-small-cell Lung Cancer
Study Details
Study Description
Brief Summary
To evaluate the efficacy and safety of Endostar combined with concurrent chemo-radiotherapy (CCRT) in patients with unresectable stage III non-small-cell lung cancer (NSCLC).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
OBJECTIVES:
Primary:To assess the treatment response rate (RR) of Endostar in combination with CCRT
Secondary
-
The progression-free survival (PFS)
-
The overall survival(OS).
-
The failed treatment modality.
-
The toxicity of this regimen.
OUTLINE CCRT:Patients receive chemotherapy comprising Docetaxel(65mg/m2,iv gtt duration>1h) and Cisplatin(65mg/m2,concurrent hydration) on days 1 and 29 and at least 3 hours after chemotherapy undergo concurrent 3D-CRT five days a week for total dose 60-66Gy.
Endostatin:Patients receive Endostatin 7.5mg/m2 daily by iv gtt up to 7 days consecutively 1 week before radiotherapy and repeat every 2 weeks.
Patients are seen in follow-up every 3 months for 2 years and then every 6 months thereafter. Physical examination and CT scans of the thorax and upper abdomen are performed routinely.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Endostatin combine CCRT 7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks |
Drug: Endostatin
7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Response Rate (RR) [4 weeks after CCRT]
Tumor response was evaluated with thoracic CT scans when CCRT was completed, in accordance with Response Evaluation Criteria in Solid Tumors Group (RECIST).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18 years of age
-
untreated pathologically confirmed inoperable stage IIIA or IIIB NSCLC
-
weight loss of less than 10% in the past 6 months
-
performance status (PS) of 0 to 1
-
forced vital capacity in 1 second (FEV1) higher than 0.8 L
-
measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST).
-
absolute neutrophil count (ANC) of ≥ 1500/μL
-
hemoglobin ≥ 10 mg/dL
-
platelet ≥ 100,000/μL
-
serum creatinine ≤ 1.25 times of upper limit of normal (ULN)
-
calculated creatinine clearance (CrCl) of ≥ 60 ml/min
-
bilirubin 1.5×ULN
-
AST and ALT less than 2.5×ULN
-
alkaline phosphatase less than 5×ULN.
Exclusion Criteria:
-
active infection
-
history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
-
malnutrition (loss of ≥ 20% of the original body weight)
-
sensor or motor neuropathy > grade I
-
second primary malignancy, except for non-melanoma skin cancer
-
psychiatric illness or social situation that would preclude study compliance
-
pregnant or lactating women
-
preexisting bleeding diatheses or coagulopathy
-
Prior chemotherapy,chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sun Yat-Sen University Cancer Center | Guangzhou | Guangdong | China | 510060 |
Sponsors and Collaborators
- Sun Yat-sen University
- The Affiliated Hospital of Guangdong Medical College
- Fujian Province Tumor Hospital
- Fifth Affiliated Hospital, Sun Yat-Sen University
- The Affiliated Tumor Hospital of Guangxi Medical University
- Zhejiang Cancer Hospital
- Guangzhou General Hospital of Guangzhou Military Command
- The 458 Hospital of Chinese PLA
Investigators
- Study Chair: Ming Chen, Doctor, Sun Yat-sen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DP-EN-RT
Study Results
Participant Flow
| Recruitment Details | Between May 2009 and January 2012, 50 patients from 5 centers were enrolled onto the study. |
|---|---|
| Pre-assignment Detail | Two patients refused treatment after consenting for therapy and were ultimately excluded from the trial before any treatment. |
| Arm/Group Title | Endostar Plus CCRT |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 48 |
| COMPLETED | 36 |
| NOT COMPLETED | 12 |
Baseline Characteristics
| Arm/Group Title | Endostar Plus CCRT |
|---|---|
| Arm/Group Description | 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 Participants | 48 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
35
72.9%
|
| >=65 years |
13
27.1%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
55
(10)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
10
20.8%
|
| Male |
38
79.2%
|
| Region of Enrollment (participants) [Number] | |
| China |
48
100%
|
Outcome Measures
| Title | Response Rate (RR) |
|---|---|
| Description | Tumor response was evaluated with thoracic CT scans when CCRT was completed, in accordance with Response Evaluation Criteria in Solid Tumors Group (RECIST). |
| Time Frame | 4 weeks after CCRT |
Outcome Measure Data
| Analysis Population Description |
|---|
| Response rate (RR)include complete response and partial response. |
| Arm/Group Title | Endostar Plus CCRT |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 48 |
| Number [percentage of participants] |
37
77.1%
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Endostar Plus CCRT | |
| Arm/Group Description | 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. | |
All Cause Mortality |
||
| Endostar Plus CCRT | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Endostar Plus CCRT | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/48 (4.2%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| pneumonitis | 1/48 (2.1%) | 1 |
| special pneumohemothorax | 1/48 (2.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Endostar Plus CCRT | ||
| Affected / at Risk (%) | # Events | |
| Total | 48/48 (100%) | |
| Blood and lymphatic system disorders | ||
| Hematologic toxicity | 47/48 (97.9%) | 47 |
| Gastrointestinal disorders | ||
| Esophagitis | 43/48 (89.6%) | 43 |
| Vomiting | 19/48 (39.6%) | 19 |
| Respiratory, thoracic and mediastinal disorders | ||
| Dyspnea | 5/48 (10.4%) | 5 |
| pneumonitis | 20/48 (41.7%) | 20 |
| Skin and subcutaneous tissue disorders | ||
| Dermatology | 47/48 (97.9%) | 47 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Ming Chen |
|---|---|
| Organization | Sun Yat-Sen University Cancer Center |
| Phone | 86-20-87343640 |
| chenming@sysucc.org.cn |
- DP-EN-RT