search
Back to results

Cisplatin/Etoposide and Concurrent Radiotherapy With or Without Celecoxib in Patients With Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC)

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Celecoxib
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Celecoxib, phase II

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • 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 Criteria:

  • • 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.

Sites / Locations

  • Cancer Hospital, Chinese Academy of Medical SciencesRecruiting
  • Jun LiangRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Celecoxib

Arm Description

Combination of and concurrent radiotherapy Cisplatin/etoposide with or without Celecoxib. Intervention: Drug: Celecoxib

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

progression-free survival

Full Information

First Posted
January 1, 2012
Last Updated
January 3, 2012
Sponsor
Chinese Academy of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT01503385
Brief Title
Cisplatin/Etoposide and Concurrent Radiotherapy With or Without Celecoxib in Patients With Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC)
Official Title
A Randomized Phase II Trial of Cisplatin/Etoposide and Concurrent Radiotherapy With or Without Celecoxib in Patients With Unresectable Locally Advanced Non-small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 the most commonly used regimens. However, the prognosis of these patients is still rather poor. It has been demonstrated that Cyclooxygenase (COX)-2 plays an important role in the pathogenesis of lung cancer. Selective (COX)-2 inhibitors can promote chemosensitivity and radiosensitivity of tumor cells in preclinical trials. This is a single-institution, open-label, randomized phase II trial of celecoxib administered concurrently with cisplatin, etoposide, and radiation therapy in patients with locally advanced NSCLC, to determine the feasibility, activity, and toxicity of this combination on unresectable NSCLC, and further to examine biomarkers to predict response to the treatment.
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 has shown the safety and efficiency of celecoxib in some phase I/II studies. The purposes of this study are to examine the effects of a new combination of celecoxib (Celebrex®) and cisplatin/etoposide (EP regimen), with concurrent thoracic radiotherapy on unresectable stage III NSCLC patients; and to examine biomarkers to predict response to the treatment. Because of poor survival of patients with unresected locally advanced NSCLC, the efficiency of celecoxib plus concurrent EP chemoradiotherapy need to be further investigated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Celecoxib, phase II

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Celecoxib
Arm Type
Experimental
Arm Description
Combination of and concurrent radiotherapy Cisplatin/etoposide with or without Celecoxib. Intervention: Drug: Celecoxib
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Other Intervention Name(s)
Celebrex
Intervention Description
400 mg by mouth twice daily for for 5-7 days before beginning radiation therapy; continued 7 days per week throughout radiation treatment (about 6 weeks).
Primary Outcome Measure Information:
Title
overall survival
Time Frame
3 year overall survival
Secondary Outcome Measure Information:
Title
progression-free survival
Time Frame
3 year progression-free survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • 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 Criteria: • 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Liang, Doctor
Phone
8610-87788503
Email
lj139117@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luhua Wang, Doctor
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Cancer Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Jun, Doctor
Phone
+861087788503
Email
lj139117@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Wang luhua, Doctor
Phone
+861087788799
Email
wlhwq@yahoo.com
First Name & Middle Initial & Last Name & Degree
Chen Bo, Doctor
Facility Name
Jun Liang
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Liang, Doctor
Phone
8610-87788503
Email
lj139117@yahoo.com.cn

12. IPD Sharing Statement

Citations:
PubMed Identifier
31851351
Citation
Bi N, Liang J, Zhou Z, Chen D, Fu Z, Yang X, Feng Q, Hui Z, Xiao Z, Lv J, Wang X, Zhang T, Wang X, Deng L, Wang W, Wang J, Liu L, Hu C, Wang L. Effect of Concurrent Chemoradiation With Celecoxib vs Concurrent Chemoradiation Alone on Survival Among Patients With Non-Small Cell Lung Cancer With and Without Cyclooxygenase 2 Genetic Variants: A Phase 2 Randomized Clinical Trial. JAMA Netw Open. 2019 Dec 2;2(12):e1918070. doi: 10.1001/jamanetworkopen.2019.18070.
Results Reference
derived

Learn more about this trial

Cisplatin/Etoposide and Concurrent Radiotherapy With or Without Celecoxib in Patients With Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC)

We'll reach out to this number within 24 hrs