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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


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Nasopharyngeal Neoplasms

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Distant failure free survival

Outcome Time Frame:

three years

Safety Issue:

No

Principal Investigator

Li Gao, MD

Investigator Role:

Study Director

Investigator Affiliation:

Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Authority:

China: Food and Drug Administration

Study ID:

CH-HN-002

NCT ID:

NCT01797900

Start Date:

March 2013

Completion Date:

June 2014

Related Keywords:

  • Nasopharyngeal Neoplasms
  • adjuvants
  • inductive
  • concurrent
  • chemoradiotherapy
  • high-risk
  • locally advanced
  • NPC
  • Neoplasms
  • Carcinoma
  • Nasopharyngeal Neoplasms

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