Neoplasms

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

All Conditions

Rare Diseases

Nasopharyngeal Carcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Antineoplastic Agents

Celecoxib

Nedaplatin

Cyclooxygenase 2 Inhibitors

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Concurrent radiotherapy with Nedaplatin 40mg/m2/week through intravenous infusion.

Celecoxib 200mg bid po; Concurrent radiotherapy with Nedaplatin 40mg/m2/week through intravenous infusion.

Celecoxib 200mg bid po, to the end of concurrent radiotherapy

40 mg/m2, IV (in the vein) on day 1 of each 7 day cycle. Number of Cycles: to the end of concurrent radiotherapy

The standard radiotherapy schedules were available as conventional radiotherapy and Intensity Modulated Radiotherapy (IMRT). The cumulative radiation dose was 68\~74 Gy for primary tumor (2.0\~2.3 Gy/f/day, 5 day/ week, /6\~7 weeks), and 50\~54 Gy for lymphatic positive area (1.8 \~ 2 Gy/f/day, 5 day/week, /5.0\~5.5 weeks).

Concurrent Radiotherapy

Yan Mao, M.D.

Changjie Huang

The purpose of this study is to determine whether celecoxib is effective in the treatment of nasopharyngeal carcinoma by concurrent chemoradiation with weekly nedaplatin.

1. Study Patients:

   Patients are all recruited from the Third Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China. All the patients provide written informed consent before enrollment. All eligible patients received a pretreatment evaluation including complete history and physical examination, endoscopic biopsy, routine laboratory tests for hematologic, renal and hepatic function as well as a dental and nutritional evaluation prior to treatment. Radiological investigations consisted of computed tomography (CT) scan or magnetic MRI of the nasopharynx, chest radiography, ultrasound of the upper abdomen and bone scintigraphy. Pathologic confirmation of nasopharyngeal cancer (NPC) was performed and re-classified according to the world health organization (WHO) subtypes.
2. Study design:

   A total of 120 NPC patients are randomly and equally divided into two groups: Nedaplatin alone concurrent radiotherapy, Celecoxib plus nedaplatin concurrent radiotherapy. The tumor response will be evaluated by magnetic resonance imaging (MRI) after 4 weeks. The tumor responses including Complete Response (CR), Partial Response (PR) , Stable Disease (SD) and Progressive Disease (PD) is defined according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0. The show term or long term toxicity will be evaluated according to the National Cancer Institute Common Toxicity Criteria (NCICTC), version 3.0. All the NPC patients are requested to be followed up with an expected average of every 3 months after the therapy.The other clinical outcomes including the first evidence of cancer progression or death from any cause, the occurrence of distant metastasis, and the relapse of a local or nodal tumor will be evaluated as well. The follow-up will be up to 2018.
3. Statistical Analysis:

Statistical Package for the Social Sciences (SPSS 13.0) is used to analyze the effect of celecoxib on the nedaplatin concurrent radiotherapy. Cox's regression model and Kaplan-Meier method is used to conduct survival analysis. Clinical outcomes including the tumor responses, 1-year/3-year/5-year overall survival (OS), progression free survival (PFS), distant metastasis failure-free survival (DMFS) and locoregional failure-free survival (LFFS) will be analyzed. The multivariate Cox's regression model is used to adjust the confounders, including age and body mass index. P value less than 0.05 will be considered to be statistically significant.

The Effect of COX-2 Inhibitor on Radiosensitivity in Nasopharyngeal Carcinoma

The Effect of Celecoxib on Concurrent Chemoradiation With Weekly Nedaplatin in Nasopharyngeal Carcinoma

The tumor responses including Complete Response (CR), Partial Response (PR) , Stable Disease (SD) and Progressive Disease (PD) were evaluated by MRI, according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0; Short term toxicity was evaluated according to the National Cancer Institute Common Toxicity Criteria (NCICTC), version 3.0.

Overall survival (OS) is defined as the time between treatment initiation and the patient death.

Progression free survival (PFS) is defined as the time between treatment initiation and the first evidence of cancer progression or death from any cause.

Distant metastasis failure-free survival (DMFS) is defined as the time between treatment initiation and the occurrence of distant metastasis.

Locoregional failure-free survival (LFFS) is defined as the time between treatment initiation and the relapse of a local or nodal tumor.

The Treatment-Related Adverse Events are assessed by the National Cancer Institute Common Toxicity Criteria (NCICTC), version 3.0.

Age is defined as the time between the birthday and treatment initiation.

High and weight are measured in standing posture without shoes by trained nurses. Body mass index is calculated form weight in kilograms divided by height in meters squared.

head of the medical department

Digestive System Diseases

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gastrointestinal Agents

Irinotecan

Pancrelipase

Pancreatin

Topoisomerase I Inhibitors

Celecoxib, Irinotecan and Concurrent Radiotherapy

Patients will start celecoxib (200mg PO BID) beginning 3-5 days prior to chemoradiation at home and receive the drug until 30 days following the completion of chemoradiation.

celecoxib

Preoperative chemoradiation will consist of escalating doses of irinotecan (30 50 mg/m2 IV) once weekly for a total of 4 doses.

irinotecan

50.4 cGy of standard external beam radiation. The radiation will be given in 28 treatments of 1.8 cGy per treatment over 5.5 weeks. This will be given in an outpatient setting.

concurrent radiotherapy

A. J. Moser, MD

The purposes of this study are to examine the effects of a new combination of drugs, celecoxib (Celebrex®) and irinotecan (CPT-11), with standard radiation therapy on people before they undergo surgery; to determine what effects this combination has on pancreatic cancer; and to determine the highest dose of celecoxib and irinotecan that can be given safely without causing severe side effects. While not an endpoint, it is hoped that this combination will also shrink tumors enough for excision.

Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer

A Phase I Study of Celecoxib, Irinotecan and Concurrent Radiotherapy in the Preoperative Treatment of Pancreatic Cancer

Pharmacia and Upjohn

University of Pittsburgh

A. James Moser, MD

Symptoms and General Pathology

Blood and Lymph Conditions

Recurrence

Thymoma

Thymus Neoplasms

Thoracic Neoplasms

Lymphatic Diseases

Etoposide

Cisplatin

Etoposide phosphate

Cisplatin, Etoposide \& concurrent radiotherapy

No distant Progression post Registration Arm

Assessment post surgical procedure to determine if at higher risk of recurrence or if complete resection could not be achieved.

Cisplatin: 50mg/m2 - administered on days 1,8,29\&36 Etoposide: 50 mg/m2 - administered on days 1-5 \& 29-33

cisplatin and etoposide

Resection will take place 4-8 weeks after completion of radiotherapy.

Surgical Resection

Robert Korst, MD

This is a phase II study for patients with thymoma or thymic carcinoma thought to be at significant risk for recurrence following surgical removal. This study involves the use of combined chemotherapy and radiation therapy prior to surgery, in hopes of increasing the chances of complete resection. The chemoradiotherapy protocol is one which has been used extensively for other diseases, and the side effects are therefore well-documented. Patients with thymomas thought to be at significant risk for recurrence (by x-ray and pathology criteria) will be allowed to participate, and will undergo combined chemotherapy with radiation to the chest followed by surgical removal of the tumor and postoperative chemotherapy. The main outcome measured will be the rate of pathological complete response (e.g. no active tumor in the resected specimen) to the preoperative treatment. Patients will receive postoperative treatment based on surgical and pathologic criteria.

Past experience has suggested that the ability to completely remove the thymoma using surgery is important in preventing recurrence. Strategies which would help the surgeon's ability to completely remove the tumor therefore need to be investigated.

This study represents a multi-institutional, phase II pilot trial of preoperative chemoradiotherapy followed by surgical resection and postoperative chemotherapy for patients with invasive thymoma or thymic carcinoma at significant risk for recurrence. We hypothesize that this strategy will be well-tolerated and produce response and resectability rates exceeding those previously published involving surgical resection alone, or preoperative chemotherapy followed by surgery. Patients with locally advanced thymoma, based on radiographic and biopsy criteria, will undergo pretreatment computed tomography (CT) scan and positron emission tomography (PET) followed by concurrent (simultaneous) chemotherapy (cisplatin and etoposide) and radiation. After this therapy, patients will be reassessed using computed tomography (CT) and PET, and undergo surgical resection of their tumors. Following resection, patients will be either observed, or treated with postoperative chemotherapy, or chemotherapy and radiation. Correlative genomic, serologic and pathologic studies will also be performed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effect of COX-2 Inhibitor on Radiosensitivity in Nasopharyngeal Carcinoma	NCT02537925	Nasopharyngeal ...	Celecoxib Nedaplatin Concurrent Radi...	18 Years - 60 Years	Nanning Second People's Hospital
Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer	NCT00177853	Pancreatic Canc...	celecoxib irinotecan concurrent radi...	18 Years -	University of Pittsburgh
Preoperative Treatment of Patients With High Risk Thymoma	NCT00387868	Thymoma	cisplatin and e... Surgical Resect... Concurrent Radi...	18 Years -	Valley Health System
The Effect of COX-2 Inhibitor on Radiosensitivity in Nasopharyngeal Carcinoma	NCT02537925	Nasopharyngeal ...	Celecoxib Nedaplatin Concurrent Radi...	18 Years - 60 Years	Nanning Second People's Hospital

Spots Global Cancer Trial Database for concurrent radiotherapy