Status:
UNKNOWN
Cisplatin/Etoposide and Concurrent Radiotherapy With or Without Celecoxib in Patients With Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Chinese Academy of Medical Sciences
Conditions:
Lung Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Concurrent chemoradiation (ChRT) is a standard care for unresectable stage III non-small cell lung cancer (NSCLC) patients with good performance status, and cisplatin/etoposide (EP) regimen is one of ...
Detailed Description
Celecoxib is a non-steroidal-anti-inflammatory drug (NSAIDS) Recent studies have shown that celecoxib has antitumor activity, and may increase the tumor sensitivity to radiation. Furthermore, evidence...
Eligibility Criteria
Inclusion
- • 18-70 years old, male or female
- Histological or cytological evidence of NSCLC.
- Unresectable Stage III NSCLC.
- Karnofsky score: at least 70.
- Estimated survival: at least 6 months
- Not receiving radiotherapy or combined modality therapy to treat another malignancy.
- No history of active gastric ulcer, active GI bleeding, or renal failure.
- No severe hypertension, cardiac disease, or diabetes mellitus
- Normal blood routine and chemical tests
- Patients or guardian must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Exclusion
- • Other malignancies simultaneously except in situ cervix or non-melanoma skin cancer
- Extensive distant metastases
- Pregnancy or in lactation
- Allergic to Sulfonamides, NSAIDS or Celebrex
- Routine use of NSAIDS such as high dose of Aspirin
- History of cardiovascular diseases including: myocardial infraction, angina, coronary angioplasty, congestive heart failure, stroke, or coronary bypass surgery in the last 6 months.
- Abnormal coagulation or history of deep venous thrombosis, pulmonary embolism, systemic lupus erythematous, family history of protein S or C deficiencies, prior heparin-induced thrombocytopenia, Factor V Leiden deficiencies or high homocysteine levels.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01503385
Start Date
December 1 2011
End Date
December 1 2016
Last Update
January 4 2012
Active Locations (2)
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1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
2
Jun Liang
Beijing, Beijing Municipality, China, 100021