Study of Concurrent Chemotherapy and Radiotherapy for Stage II Nasopharyngeal Carcinoma
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 Recruiting
Recruitment status was Recruiting
Sponsor:
Fudan University
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00817258
First received: January 2, 2009
Last updated: January 5, 2009
Last verified: January 2009
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Purpose
The primary objective of this study is to determine the overall survival in patients with stage II (T1-2N1M0) NPC treated with concurrent chemotherapy and radiotherapy.
Secondary objectives of the study are to evaluate the disease free survival, and distant metastases free survival of patients with stage II NPC treated with this regimen
| Condition | Intervention | Phase |
|---|---|---|
|
Nasopharyngeal Carcinoma |
Drug: cisplatin Radiation: 3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase Ⅱ Study of Concurrent Chemotherapy and Radiotherapy for Stage II 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:
- disease-free survival, and distant metastases free survival [ Time Frame: 3 and 5 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 37 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
All patients will receive radical radiotherapy with 3D-CRT or IMRT, and cisplatin (40mg/m2) weekly during external radiotherapy.
|
Drug: cisplatin
Cisplatin 40mg/m2,weekly
Radiation: 3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)
3D-CRT or IMRT
|
Detailed Description:
Radiotherapy alone is the standard treatment for early stage NPC. In retrospective study of early stage NPC patients treated with radiotherapy alone. Patients who had Stage II disease had a worse outcome compared with patients with stage I disease. Chemotherapy, delivered concurrently with radiation therapy, has been adopted as standard treatment for locally advanced NPC. However, concurrent chemoradiation for stage II NPC patients has never been prospectively studied. In the present trial, we hope to assess the value of concurrent chemotherapy and radiotherapy in patients with stage II (T1-2N1) NPC.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically proven differentiated non-keratinizing carcinoma, and undifferentiated carcinoma of the nasopharynx.
- Stage II disease (T1-2; N1; M0)
- 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.
- 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: NCT00817258
Contacts
| Contact: Lin Kong, MD | 8621-64175590 ext 3900 | konglinj@gmail.com |
Locations
| China | |
| Department of Radiation Oncology, Cancer Hospital, Fudan University | Recruiting |
| Shanghai, China, 200032 | |
| Contact: Jing Yuan 8621-64175590 ext 6511 skelly_sh@hotmail.com | |
Sponsors and Collaborators
Fudan University
Investigators
| Principal Investigator: | Lin Kong, MD | Department of Radiation Oncology, Cancer Hospital, Fudan University |
| Principal Investigator: | Chaosu Hu, MD | Department of Radiation Oncology, Cancer Hospital, Fudan University |
More Information
No publications provided
| Responsible Party: | Department of Radiation Oncology,Cancer Hospital, Fudan University, Shanghai, China, Cancer Hospital, Fudan University, Shanghai, China |
| ClinicalTrials.gov Identifier: | NCT00817258 History of Changes |
| Other Study ID Numbers: | NPC-0701 |
| Study First Received: | January 2, 2009 |
| Last Updated: | January 5, 2009 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Fudan University:
|
Phase 2 Clinical Trial NPC radiation therapy chemotherapy |
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 Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013