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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Cancer Hospital of Guangxi Medical University
Sponsor:
Information provided by (Responsible Party):
Cancer Hospital of Guangxi Medical University
ClinicalTrials.gov Identifier:
NCT02116231
First received: April 2, 2014
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Effects of Chemotherapy
Drug: Concurrent chemotherapy with cisplatin
Radiation: Intensity modulated radiotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study Comparing Intensity Modulated Radiotherapy (IMRT) in Combination With Concurrent Chemotherapy and IMRT Alone for Stage II Nasopharyngeal Carcinoma

Resource links provided by NLM:


Further study details as provided by Cancer Hospital of Guangxi Medical University:

Primary Outcome Measures:
  • Failure-free survival (FFS) [ Time Frame: One year ] [ Designated as safety issue: No ]
    The time is calculated from the date of diagnosis to the date of occurrence of relapse or distant metastasis.


Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: One year ] [ Designated as safety issue: No ]
    The time is calculated from the date of diagnosis to the date of patient death.

  • Loco-regional failure-free survival (LFFS) [ Time Frame: One year ] [ Designated as safety issue: No ]
    The time is calculated from the date of diagnosis to the date of a relapse of local or nodal tumors.

  • Distant metastasis failure-free survival (DMFS) [ Time Frame: One year ] [ Designated as safety issue: No ]
    The time is calculated from the date of diagnosis to the date of occurrence of relapse or distant metastasis.

  • Acute and late adverse events [ Time Frame: Four months ] [ Designated as safety issue: Yes ]
    The side effects will be evaluated according to CTCAE V 3.0.


Estimated Enrollment: 80
Study Start Date: April 2014
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Concurrent chemotherapy with cisplatin
Three cycles of weekly Cisplatin 100 mg/m2 starting on the first day of IMRT
Radiation: Intensity modulated radiotherapy
Intensity modulated radiotherapy is a technique of radiotherapy.
Active Comparator: 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.
Radiation: Intensity modulated radiotherapy
Intensity modulated radiotherapy is a technique of radiotherapy.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02116231

Contacts
Contact: Xiaodong Zhu, Doctor zhuxiaodong83@163.com

Locations
China, Guangxi
Cancer Hospital of Guangxi Medical University Not yet recruiting
Nanning, Guangxi, China, 530021
Contact: Xiaodong Zhu, Doctor       zhuxiaodong83@163.com   
Principal Investigator: Song Qu, Doctor         
Principal Investigator: Ling Li, Master         
Sponsors and Collaborators
Cancer Hospital of Guangxi Medical University
  More Information

Additional Information:
Publications:
Responsible Party: Cancer Hospital of Guangxi Medical University
ClinicalTrials.gov Identifier: NCT02116231     History of Changes
Other Study ID Numbers: CHGX20140402
Study First Received: April 2, 2014
Last Updated: April 15, 2014
Health Authority: National Health and Family Planning Commission of the People's Republic of China: China

Keywords provided by Cancer Hospital of Guangxi Medical University:
Nasopharyngeal neoplasm;IMRT; Concurrent chemotherapy

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
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014