Radiotherapy Combined With Iressa for EGFR Mutation Positive Patients With Locally Advanced Non-small Cell Lung Cancer (NSCLC)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to access the effect and safety of radiotherapy combined whth Iressa for patients with locally advanced non-small cell lung cancer with harboring active EGFR mutations.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-small Cell Lung Cancer |
Other: Gefitinib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Radiation Therapy Combined With Iressa in Patients With Locally Advanced Non-small Cell Lung Cancer With Harboring Active EGFR Mutations |
- Response rate (RR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Progression free survival (PFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Overall survival (OS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Quality of life (MD-Anderson questionnaire) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | July 2017 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Radiotherapy Combined With Gefitinib |
Other: Gefitinib
Radiation Therapy: 3D-CRT/IMRT 95%PTV 60-66Gy, 1.8-2.0Gy/f,5f/w; Gefitinib: 250 mg, Qd, p.o;
Other Name: Iressa
|
Detailed Description:
Worldwide more than half a million new cases of lung cancer are diagnosed annually. About 80% of these tumours are of non-small cell histological type. Surgery is the treatment of choice, but only about 20% of tumours are suitable for potentially curative resection. Concurrent chemoradiotherapy is the standard treatment for locally advanced NSCLC. When Iressa was used in the first-line treatment of advanced NSCLC with EGFR mutations positive, the 12-month rates of progression-free survival were 24.9%. Therefore, we speculate that the EGFR mutations in patients with locally advanced NSCLC, Gefitinib combined with radiotherapy may be better than chemoradiotherapy. We design the study to access the effect and safety of radiotherapy combined whth Iressa for patients with locally advanced non-small cell lung cancer with harboring active EGFR mutations.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically confirmed diagnosis of non-squamous NSCLC; Stage ⅢA-ⅢB(not suitable for surgery) or stage Ⅳ(only single-site single transfer );
- Untreated patients, or who completed ≤ 2 cycles of first-line chemotherapy (chemotherapy regimen: paclitaxel, docetaxel + cisplatin) within the previous month;
- Patients with tumor EGFR mutation positive (exon 19 deletion mutation or exon 21 L858R substitution mutation);
- Patients must be informed of the investigational nature of the study and must sign an informed consent form;
- Presence of at least one measurable/evaluable according to RECIST criteria.
- ECOG performance Status 0-2 ;
- Patients must have a life expectancy > 12 weeks;
- Patients with laboratory values as follows:WBC>4.0 x 109/L; ANC≥1.5 x 109/L; PLT≥100 x 109/L; HGB≥10 g/dL; CR≤1.5 x ULN; TBIL<1.5 x ULN; AST and ALT≤1.5 x ULN; LDH≤1.5 x ULN; AKP≤5 x ULN;
- FEV 1≥1.0L and >50% Corresponding normal values;
- Patient candidate to standard platinum-based chemotherapy;
- Patients must be nonpregnant and non-lactating.Patients of childbearing potential must implement an effective method of contraception during the study. All female Patients, except those who are postmenopausal or surgically sterilized, must have a negative pre-study serum or urine pregnancy test.
Exclusion Criteria:
- Any evidence of clinically active interstitial lung disease;
- Diagnosis of any other malignancy during the last 5 years, except for in situ carcinoma of cervix uterine and squamous cell carcinoma of the skin;
- Pregnancy or lactating;
- Serious concomitant infection;
- MI within preceding 6 months or symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia;
- As judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg, unstable or uncompensated respiratory, cardiac, hepatic, or renal disease);
- Patients who are not suitable to participate in the trial according to researchers.
Contacts and Locations| Contact: Yu Rong | yurong311@yahoo.cn |
| China, Beijing | |
| 307 Hosptial of PLA | Recruiting |
| Beijing, Beijing, China, 100000 | |
| Principal Investigator: Ge Shen | |
| Chinese Academy of Medical Sciences Cancer Hospital | Recruiting |
| Beijing, Beijing, China, 266000 | |
| Principal Investigator: Lvhua Wang | |
| China, Hubei | |
| Renmin Hospital of Wuhan University, Hubei General Hospital | Recruiting |
| Wuhan, Hubei, China, 430060 | |
| Principal Investigator: Qibin Song | |
| China, Shanghai | |
| Fudan University Shanghai Cancer Center | Recruiting |
| Shanghai, Shanghai, China, 200000 | |
| Principal Investigator: Min Fan | |
| China, Zhejiang | |
| Zhejiang Cancer Hospital | Recruiting |
| Hangzhou, Zhejiang, China, 310000 | |
| Principal Investigator: Shenglin Ma | |
| China | |
| Beijing Cancer Hospital | Recruiting |
| Beijing, China, 100000 | |
| Contact: Guangying Zhu zgypu@yahoo.com.cn | |
| Contact: Rong Yu yurong311@yahoo.cn | |
| Principal Investigator: Guangying Zhu | |
| Principal Investigator: | Zhu Guangying | Beijing Cancer Hospital |
More Information
No publications provided
| Responsible Party: | Zhu Guangying, Beijing Cancer Hospital |
| ClinicalTrials.gov Identifier: | NCT01391260 History of Changes |
| Other Study ID Numbers: | CS-S10-09 |
| Study First Received: | July 7, 2011 |
| Last Updated: | August 1, 2011 |
| Health Authority: | China: Ethics Committee |
Keywords provided by ZhuGuangYing:
|
Locally Advanced NSCLC EGFR Mutation Positive Radiotherapy combined Gefitinib |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases |
Respiratory Tract Diseases Gefitinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013