Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma (NPC) (TPF for NPC)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Fudan University.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Fudan University
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00817583
First received: January 5, 2009
Last updated: January 26, 2009
Last verified: January 2009
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Purpose
The primary objective of this study is to determine the response rate, tolerance and overall survival in patients with stage III, IVa, IVb NPC treated with neoadjuvant chemotherapy (TPF regimen) and concurrent chemoradiation.
Secondary objectives of the study are to evaluate the distant metastases free survival, and disease-free survival of patients with stage III,IVa, IVb NPC treated with this regimen.
The third objective of this study is to evaluate who may benifit from this treatment regimen.
| Condition | Intervention | Phase |
|---|---|---|
|
Nasopharyngeal Carcinoma |
Drug: docetaxel, cisplatin, fluorouracil Radiation: 3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phse II Study of Induction Chemotherapy With TPF Regimen Followed by Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma |
Resource links provided by NLM:
Further study details as provided by Fudan University:
Primary Outcome Measures:
- overall survival [ Time Frame: 3 and 5 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- distant metastases free survival , and disease-free survival [ Time Frame: 3 and 5 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
All patients will receive docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; and a continuous intravenous fluorouracil infusion at 500 mg/m2/d on days 1 through 5. Cycles are repeated every 21 days for a total of two cycles. Patients then will receive definitive radiotherapy with 3D-CRT or IMRT, and cisplatin (40mg/m2) weekly during external radiotherapy.The radiation dose is 66-76Gy to the GTV, 60Gy to CTV1, and 54Gy to CTV2.
|
Drug: docetaxel, cisplatin, fluorouracil
neoadjuvant chemotherapy:docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; continuous fluorouracil infusion at 500 mg/m2/d on days 1 through 5. concurrent chemotherapy:cisplatin 40 mg/m2 weekly |
Detailed Description:
Concurrent chemoradiation is the standard treatment for locally advanced NPC. The survival benefit gained from adding induction chemotherapy to concurrent chemoradiation has not been defined yet. In the present clinical study, we hope to assess the tolerance and survival benefits of induction chemotherapy followed by concurrent chemoradiation in patients with stage III, IVa and IVb NPC.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- -Histopathologically proved WHO type II and type III carcinoma of the nasopharynx.
- Stage Ⅲ, IVa and IVb disease
- KPS >70
- Age between 18-70
- Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of > 2000 cells/mm3, platelet count of > 100,000 cells/mm3 (pre treatment without intervention). Bilirubin < 1.5 mg/dl, AST or ALT<2 x upper normal, serum creatinine<1.5mg/dl, creatinine clearance >50ml/min.
- the primary tumor or involved lymph node must be more than 2CM in diameter.
- No prior radiation treatment to the head and neck or any prior chemotherapy
- Patients with no prior malignancy (not include basal cell carcinoma of skin)
Exclusion Criteria:
- Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations.
- Prior radiotherapy to the head and neck region for any reason.
- Initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease.
- Patients with previous or simultaneous primaries, excluding basal cell carcinoma or squamous cell carcinoma of skin.
- Pregnant women
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00817583
Contacts
| Contact: ChaoSu HU, M.D. | 86-21-64175590 ext 6517 | hucsu62@yahoo.com |
| Contact: XiaoShen WANG, M.D. | 86-21-64175590 ext 6516 | wangxiaoshen@gmail.com |
Locations
| China, Shanghai | |
| Department of Radiation Oncology, Cancer Hospital, Fudan University | Recruiting |
| Shanghai, Shanghai, China, 200032 | |
| Contact: Xiaoshen Wang, M.D. 86-21-64175590 ext 6516 wangxiaoshen@gmail.com | |
| Contact: TingTing Xu, M.D. 86-21-64175590 ext 6511 littlepuppyxtt@gmail.com | |
Sponsors and Collaborators
Fudan University
Investigators
| Principal Investigator: | XiaoShen WANG, M.D. | Department of Radiation Oncology, Cancer Hospital, Fudan University |
| Study Chair: | ChaoSu HU, M.D. | Department of Radiation Oncology, Cancer Hospital, Fudan University |
| Principal Investigator: | ChunYing Shen, M.D. | Department of Radiation Oncology, Cancer Hospital, Fudan University |
| Principal Investigator: | HongMei Ying, M.D. | Department of Radiation Oncology, Cancer Hospital, Fudan University |
More Information
No publications provided
| Responsible Party: | cancer hospital, Fudan University |
| ClinicalTrials.gov Identifier: | NCT00817583 History of Changes |
| Other Study ID Numbers: | NPC20081, NPC20081, NPC20081-1 |
| Study First Received: | January 5, 2009 |
| Last Updated: | January 26, 2009 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Fudan University:
|
Phase 2 Clinical Trial NPC neoadjuvant chemotherapy concurrent chemoradiation |
Additional relevant MeSH terms:
|
Carcinoma Nasopharyngeal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site Nasopharyngeal Diseases Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases |
Docetaxel Cisplatin Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on June 17, 2013