Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma (NPC)

NCT00817583 | Unknown Phase 2 DMC

• 2 other identifiers: NPC20081NPC20081-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nasopharyngeal Carcinoma

Keywords

Phase 2 Clinical Trial; NPC; neoadjuvant chemotherapy; concurrent chemoradiation

Outcome Measures

Primary Outcomes (1)

• overall survival

  3 and 5 years

Secondary Outcomes (1)

• distant metastases free survival , and disease-free survival

  3 and 5 years

Study Arms (1)

1

EXPERIMENTAL

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; Radiation: 3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)

Interventions

docetaxel, cisplatin, fluorouracil DRUG

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

1

3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy) RADIATION

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Department of Radiation Oncology, Cancer Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Docetaxel; Cisplatin; Fluorouracil; Radiotherapy, Conformal; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• XiaoShen WANG, M.D.

  Department of Radiation Oncology, Cancer Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

• ChaoSu HU, M.D.

  Department of Radiation Oncology, Cancer Hospital, Fudan University

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ChaoSu HU, M.D.

CONTACT

86-21-64175590; hucsu62@yahoo.com

XiaoShen WANG, M.D.

CONTACT

86-21-64175590; wangxiaoshen@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 5, 2009
• First Posted: January 6, 2009
• Study Start: January 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2011
• Last Updated: January 27, 2009

Record last verified: 2009-01

Locations

CN (1)