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The Role of Induction Chemotherapy for High-risk Locally Advanced Nasopharyngeal Carcinoma in the Era of IMRT

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01797900
First Posted: February 25, 2013
Last Update Posted: September 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Li Gao, Chinese Academy of Medical Sciences
  Purpose
The purpose of this study is to determine whether Intensity-modulated radiation therapy (IMRT) combined inductive and concurrent chemotherapy with more intensive regimen (cisplatin and paclitaxel) is feasible and effective than current standard treatment for high-risk locally advanced NPC patients.

Condition Intervention Phase
Nasopharyngeal Neoplasms Drug: Cisplatin Drug: Paclitaxel Radiation: IMRT Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Inductive Plus Concurrent Chemoradiation Versus Concurrent Plus Adjuvant Chemoradiation for High-risk Locally Advanced Nasopharyngeal Carcinoma in the Era of IMRT

Resource links provided by NLM:


Further study details as provided by Li Gao, Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • Distant failure free survival [ Time Frame: three years ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: three years ]
  • acute treatment toxicity [ Time Frame: up to 16 weeks ]
  • late treatment toxicity [ Time Frame: three years ]
  • Local recurrence rate [ Time Frame: three years ]

Enrollment: 130
Study Start Date: March 2013
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inductive + concurrent chemotherapy
Inductive chemotherapy :paclitaxel 175mg/m2 d1+ cisplatin 80mg/m2d1, every 21 days for two cycles concurrent chemotherapy:cisplatin 80mg/m2 on week 1, 4, 7 radiotherapy: IMRT
Drug: Cisplatin
induction: Cisplatin: 80mg/m2, d1 and d22 concurrent: Cisplatin: 100mg/m2, d1, 22, 43 adjuvant: cisplatin: 75mg/m2, d1, d22, d43,d64
Drug: Paclitaxel
induction: paclitaxel 175mg/m2 d1,d22 adjuvant: paclitaxel 175mg/m2 d1,d22, d43,d64
Radiation: IMRT
69.96Gy-73.43Gy to gross tumor volume, 60Gy to high-risk clinincal target volume, 50Gy to lower risk clincial target volume
Other Name: intensity-modulated radiotherapy
Active Comparator: concurrent + adjuvant chemotherapy
concurrent chemotherapy: cisplatin 80 mg/m2, on week 1, 4, 7 adjuvant chemotherapy: paclitaxel 175mg/m2 + cisplatin 75mg/m2, every 21 days for 4 cycles radiotherapy: IMRT
Drug: Cisplatin
induction: Cisplatin: 80mg/m2, d1 and d22 concurrent: Cisplatin: 100mg/m2, d1, 22, 43 adjuvant: cisplatin: 75mg/m2, d1, d22, d43,d64
Drug: Paclitaxel
induction: paclitaxel 175mg/m2 d1,d22 adjuvant: paclitaxel 175mg/m2 d1,d22, d43,d64
Radiation: IMRT
69.96Gy-73.43Gy to gross tumor volume, 60Gy to high-risk clinincal target volume, 50Gy to lower risk clincial target volume
Other Name: intensity-modulated radiotherapy

Detailed Description:

Meta-analysis showed chemotherapy when combined with conventional radiotherapy in locally advanced naso-pharyngeal carcinoma can improve 5-year overall survival with 6%, and beyond all concurrent chemotherapy with cisplatin benefits most. However, from Lin's (Lin JC, 2004) study, locally advanced NPC with high risk factors can not benefit from conventional concurrent chemoradiation. Failure pattern analysis revealed that local and distant failure accounted for 50% respectively. Large-scale data has demonstrated that with IMRT, local control can achieve 90%. Previous studies showed inductive chemotherapy can decrease distant metastasis. We need more effective and stronger chemotherapy, and we still need to testify concurrent chemotherapy combined with inductive chemotherapy.

A prospective trial would thus provide valuable information to help physicians and patients more precisely identify the feasibility and effectiveness of inductive + concurrent chemotherapy combined with IMRT for high-risk locally advanced NPC.

  Eligibility

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • biopsy-proved NPC
  • N3 or T4N2 or multiple lymphnodes involved with at least one mass 4 cm or more in maximal diameter according to 7th UICC Staging
  • provide written informed consent
  • Kps>70
  • no dostant metastasis
  • Life expectancy≥6 months
  • Adequate renal function, defined as follows: Serum creatinine < 2 x institutional upper limitof normal(ULN) within 2 weeks prior to registration or; creatinine clearance rate (CCr) ≥ 50 ml/min within 2 weeks prior to registration determined by 24- hour collection or estimated by Cockcroft-Gault formula: CCr male = [(140 - age) x (wt in kg)] [(Serum Cr mg/dl) x (72)] CCr female = 0.85 x (CCrmale)
  • The following assessments are required within 2 weeks prior to the start of registration: Na, K, Cl, glucose, Ca, Mg, and albumin.

Exclusion Criteria:

  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) are permitted even if diagnosed and treated < 3 years ago
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Severe, active co-morbidity
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01797900


Locations
China, Beijing
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing, China, 100021
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
Study Director: Li Gao, MD Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
  More Information

Responsible Party: Li Gao, Professor, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01797900     History of Changes
Other Study ID Numbers: CH-HN-002
First Submitted: February 21, 2013
First Posted: February 25, 2013
Last Update Posted: September 10, 2014
Last Verified: September 2014

Keywords provided by Li Gao, Chinese Academy of Medical Sciences:
adjuvants
inductive
concurrent
chemoradiotherapy
high-risk
locally advanced
NPC

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action