The Role of Adding Concurrent Chemotherapy to IMRT in the Treatment of Stage II Nasopharyngeal Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2018-05-31

Brief Summary

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The study is designed to compare Intensity Modulated Radiotherapy (IMRT) in combination with concurrent chemotherapy and IMRT alone in treatment of stage II nasopharyngeal carcinoma.

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Detailed Description

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Nasopharyngeal carcinoma (NPC) is endemic in Southern China, Southeast Asia, the Arctic, and mid-East/North Africa. NPC prevalence is reported to be highest in southern China, where an average of 80 cases per 100,000 population are reported each year. It is both radiosensitive and chemosensitive. The National Comprehensive Cancer Network (NCCN) guidelines (version 1, 2013), have recommended use of concurrent chemoradiotherapy (CCRT) with or without adjuvant chemotherapy (AC) as standard treatment for NPC.

Recently, the technique of IMRT has become widely used in the treatment of nasopharyngeal carcinoma. The preliminary results showed that IMRT might improve the rate of local control and the quality of life in NPC. In a retrospective study (Ivan,2010), the result showed that IMRT without concurrent chemotherapy provides good outcome for patients with stage IIB NPC with acceptable toxicity. Another study showed that Comparing with IMRT alone, IMRT in combination with chemotherapy provided no significant benefit to locoregionally advanced NPC (Su,2011). With IMRT, it was unclear whether the additional of concurrent chemotherapy was essential for stage II nasopharyngeal carcinoma.

The investigators designed the present study to research the role of adding concurrent chemotherapy to intensity modulated radiotherapy in the treatment of stage II NPC. The primary endpoint is failure-free survival (FFS).The second endpoints were overall survival (OS),loco-regional failure-free survival (LFFS), distant metastasis failure-free survival (DMFS), and acute and late adverse events.

Conditions

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Effects of Chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Concurrent chemoradiotherapy

Concurrent chemoradiotherapy: IMRT was given to the patients with regimen of 66Gy-76Gy to the gross target volume of nasopharynx,66-70Gy to the gross target volume of positive nodes, 60-62Gy the high risk clinical target volume, 50-56Gy to the low risk clinical target volume. Concurrent chemotherapy is administrated with cisplatin 100mg/m2 at d1, d22, d43 during radiotherapy.

Group Type EXPERIMENTAL

Concurrent chemotherapy with cisplatin

Intervention Type DRUG

Three cycles of weekly Cisplatin 100 mg/m2 starting on the first day of IMRT

Intensity modulated radiotherapy

Intervention Type RADIATION

Intensity modulated radiotherapy is a technique of radiotherapy.

IMRT alone

IMRT is given to the patients with regimen of 66Gy-76Gy to the gross target volume of nasopharynx,66-70Gy to the gross target volume of positive nodes, 60-62Gy the high risk clinical target volume, 50-56Gy to the low risk clinical target volume.

Group Type ACTIVE_COMPARATOR

Intensity modulated radiotherapy

Intervention Type RADIATION

Intensity modulated radiotherapy is a technique of radiotherapy.

Interventions

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Concurrent chemotherapy with cisplatin

Three cycles of weekly Cisplatin 100 mg/m2 starting on the first day of IMRT

Intervention Type DRUG

Intensity modulated radiotherapy

Intensity modulated radiotherapy is a technique of radiotherapy.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type).
* 18 Years to 70 Years
* Tumor staged as T1-2N1/ T2N0 (according to the 7th AJCC edition),No evidence of distant metastasis (M0)
* Satisfactory performance status: Karnofsky scale (KPS) \> 70 (Appendix I ).
* Adequate marrow: leucocyte count \> 4×109/L, neutrophil count \> 2×109/L, hemoglobin \> 90g/L and platelet count \> 100×109/L
* Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) \< 2.5×ULN, and bilirubin \< ULN
* Adequate renal function: creatinine clearance \> 60 ml/min
* Patients must be informed of the investigational nature of this study and give written informed consent

Exclusion Criteria

* WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
* Age \> 60 or \< 18.
* Treatment with palliative intent.
* Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
* Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
* History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume).
* Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
* Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \> 1.5×ULN), and emotional disturbance.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No