Brief Title
A Trial On 4 Cycles Of Neoadjuvant Chemotherapy Plus Concurrent Chemoradiation In N2-3 Nasopharyngeal Carcinoma
Official Title
4 Cycles Of Neoadjuvant Chemotherapy Plus Concurrent Chemoradiation Versus Concurrent Chemoradiation Alone In Patients With Stage N2-3 Nasopharyngeal Carcinoma: A Phase 3 Multicenter Randomised Controlled Trial
Brief Summary
The standard treatment strategy of locally advanced nasopharyngeal carcinoma (NPC) nowadays
is concurrent chemoradiation (CRT) based on intensity-modulated radiation therapy (IMRT).
However, distant metastasis remains the major cause of treatment failure, especially in
patients with T1-4N2-3M0 diseases (N2-3 NPC). The investigators inferred that it was more
appropriate to consider N2-3 NPC as a systemic disease instead of a local disease. NACT of
sufficient intensity such as 4 cycles might be effective enough for control of the
pre-existing micrometastases. Therefore, the objective of this phase 3 multicenter randomized
controlled trial is to make a comparison between NACT of 4 cycles plus CRT based on IMRT and
CRT alone in N2-3 NPC on distant metastasis, survival and adverse reaction.
Detailed Description
The standard treatment strategy of locally advanced nasopharyngeal carcinoma (NPC) nowadays
is concurrent chemoradiation (CRT), which is based on intensity-modulated radiation therapy
(IMRT) and achieves a satisfactory local-regional control and a 5-year overall survival (OS)
of 83.0%. However, distant metastasis remains the major cause of treatment failure,
especially in patients with T1-4N2-3M0 diseases (N2-3 NPC). The distant metastasis reaches
35-48% after CRT alone.
To decrease distant metastasis of locally advanced NPC so as to improve survival, approaches
on modifying timing of chemotherapy have been made to mainly 2 types: one was CRT plus
adjuvant chemotherapy (ACT), the other was neoadjuvant chemotherapy (NACT) plus CRT. It was
proved that CRT plus ACT could not improve survival of locally advanced NPC further. Some
clinical trials indicated that locally advanced NPC patients with 2-3 cycles of NACT plus CRT
had a better survival than those with CRT alone though the roles of NACT remain
controversial.
It is known that N stage is by far the most significant predicting factor of metastasis risk
for NPC. N2-3 NPC was also proved to have a quite great risk of distant failure. 51.4% of
distant metastases happened within 1 year after CRT. The investigators inferred that
subclinical micrometastases were already present before treatment starting. Hence, it was
more appropriate to consider N2-3 NPC as a systemic disease instead of a local disease. NACT
of sufficient intensity such as 4 cycles might be effective enough for control of the
pre-existing micrometastases.
Therefore, this phase 3 multicenter randomized controlled trial is conducted to enroll 144
patients with N2-3 NPC. After stratification by N stage, the patients will be allocated into
2 treatment groups randomly at a ratio of 1:1 and applied with different treatment strategies
to make a comparison between NACT of 4 cycles plus CRT based on IMRT and CRT alone in N2-3
NPC on distant metastasis, survival and adverse reaction.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
5-year overall survival (5y-OS)
Secondary Outcome
5-year local-relapse-free survival (5y-RFS)
Condition
Nasopharyngeal Carcinoma
Intervention
Docetaxel (DOC)
Study Arms / Comparison Groups
CRT group (Group A)
Description: Patients who are allocated into in this group will be treated with concurrent chemoradiation (CRT).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
144
Start Date
August 2015
Completion Date
December 2024
Primary Completion Date
December 2024
Eligibility Criteria
Inclusion Criteria:
- Patients with pathological diagnosis of nasopharyngeal carcinoma
- Union Internationale Contre le Cancer/American Joint Cancer Committee (UICC/AJCC) 2010
Stage T1-4 N2-3 M0 through magnetic resonance imaging of head and neck, whole-body
bone scan and thoracoabdominal computed tomography
- Male or female with age no older than 70 years old
- Karnofsky Performance Scores ≥ 80
- Expected survival ≥ 3 months
Exclusion Criteria:
- Patients with distant metastasis before or during radiotherapy
- Severe dysfunction of heart, lung, liver, kidney or hematopoietic system
- Severe neurological, mental or endocrine diseases
- History of other malignancies
- Prior chemotherapy, radiotherapy or application of monoclonal antibodies
- Patients participated in clinical trials of other drugs within last 3 months
- Pregnant or lactating women
- Those who are considered by the researchers unsuitable to participate
Gender
All
Ages
N/A - 70 Years
Accepts Healthy Volunteers
No
Contacts
Yuan-hong Gao, M.D, +86-13560182168, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02512315
Organization ID
NACT4-NPC-5010
Responsible Party
Principal Investigator
Study Sponsor
Sun Yat-sen University
Study Sponsor
Yuan-hong Gao, M.D, Principal Investigator, Sun Yat-sen University
Verification Date
July 2017