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Intensity-modulated Radiotherapy With or Without Concurrent Chemotherapy for Stage II Nasopharyngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT02610010
Recruitment Status : Recruiting
First Posted : November 20, 2015
Last Update Posted : November 20, 2015
Sponsor:
Collaborators:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
The First Affiliated Hospital of Guangzhou Medical University
The First Affiliated Hospital of Guangdong Pharmaceutical University
Information provided by (Responsible Party):
Fang-Yun Xie, Sun Yat-sen University

Brief Summary:

A prior phase III randomized trial showed considerable survival benefit from the combined treatment of cisplatin-based concurrent chemotherapy and two-dimensional conventional radiotherapy (2DCRT) for patients with stage II (the Chinese 1992 staging system) nasopharyngeal carcinoma. However, since intensity-modulated radiotherapy (IMRT) was known to be superior to 2DCRT in local control, progression free survival and even overall survival, it is a pivotal question whether stage II [T1N1M0 and T2N0-1M0, based on the 2010 International Union against Cancer/American Joint Committee on Cancer (UICC/AJCC) staging system] patients can still obtain significant benefit from the additional concurrent chemotherapy in the IMRT era.

The investigators' retrospective study (PMID:26528755 ) indicated that low risk nasopharyngeal carcinoma (T1N1M0, T2N0-1M0 or T3N0M0, the 2010 UICC/AJCC staging system) patients who underwent IMRT could not benefit from cisplatin-based concurrent chemotherapy. Therefore, the investigators perform this randomized controlled trial to address this question, on a prudent assumption that IMRT alone was not inferior to IMRT plus concurrent chemotherapy in stage II patients.


Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: Cisplatin Radiation: Intensity-modulated radiotherapy Phase 3

Detailed Description:
Eligible patients are randomly assigned to receive intensity-modulated radiotherapy (IMRT) alone or IMRT plus concurrent chemotherapy. IMRT is given as 2.0-2.30 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor. Concurrent chemotherapy consisted of cisplatin 100 mg/m² every 3 weeks for 3 cycles. The primary endpoint is overall survival (OS). Secondary end points include failure-free survival(FFS), locoregional relapse-free survival (LRFS), distant metastasis-free survival (DMFS), toxic effects and quality of life. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 462 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intensity-modulated Radiotherapy With or Without Concurrent Chemotherapy for Stage II Nasopharyngeal Carcinoma: a Phase 3 Non-inferior Multicenter Randomized Controlled Trial
Study Start Date : November 2015
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arm Intervention/treatment
Experimental: IMRT alone
Intensity-modulated radiotherapy without cisplatin-based concurrent chemotherapy
Radiation: Intensity-modulated radiotherapy
Intensity-modulated radiotherapy

Active Comparator: IMRT plus concurrent chemotherapy
Intensity-modulated radiotherapy with cisplatin-based concurrent chemotherapy
Drug: Cisplatin
Cisplatin 100 mg/m² every 3 weeks for 3 cycles during radiotherapy.
Other Name: DDP

Radiation: Intensity-modulated radiotherapy
Intensity-modulated radiotherapy




Primary Outcome Measures :
  1. Overall survival [ Time Frame: Two year ]

Secondary Outcome Measures :
  1. failure-free survival [ Time Frame: two year ]
  2. distant metastasis-free survival [ Time Frame: two year ]
  3. locoregional relapse-free survival [ Time Frame: two year ]
  4. Number of participants with treatment-related acute adverse events as assessed by CTCAE v4.0 [ Time Frame: two months ]
  5. quality of life assessing by questionnaires [ Time Frame: through study completion, an average of 5 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly histologically confirmed non-keratinizing (WHO 1991) nasopharyngeal carcinoma.
  • Tumor staged as T1N1M0 or T2N0-1M0 (the 2010 UICC/AJCC staging system).
  • Karnofsky scale (KPS) ≥ 70.
  • Adequate marrow: leucocyte count ≥ 4×10E9/L, hemoglobin ≥ 110g/L and platelet count ≥ 100×10E9/L.
  • Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and bilirubin ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN.
  • Adequate renal function: creatinine clearance ≥ 60 ml/min or creatinine ≤ 1.5×ULN.
  • Patients must give written informed consent.

Exclusion Criteria:

  • 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 radiotherapy (except for non-melanomatous skin cancers outside intended radiotherapy volume).
  • Prior radiotherapy, 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.

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): NCT02610010


Contacts
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Contact: Fang-Yun Xie, M.D. +86-020-87342618 xiefy@sysucc.org.cn
Contact: Pu-Yun OuYang, M.D. +86-020-87342618 ouyangpy@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Fang-Yun Xie, M.D.    +86-020-87342618    xiefy@sysucc.org.cn   
Contact: Pu-Yun OuYang, M.D.    +86-020-87342618    ouyangpy@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
The First Affiliated Hospital of Guangzhou Medical University
The First Affiliated Hospital of Guangdong Pharmaceutical University
Investigators
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Principal Investigator: Fang-Yun Xie, M.D. Sun Yat-sen University Cancer Center,Guangzhou, Guangdong, China
Publications:

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Responsible Party: Fang-Yun Xie, Prof., Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02610010    
Other Study ID Numbers: 2015-FXY-066-Dept. of RT
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015
Keywords provided by Fang-Yun Xie, Sun Yat-sen University:
NPC
concurrent chemotherapy
IMRT
stage II
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cisplatin
Antineoplastic Agents