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IMRT Plus Cisplatin Versus IMRT in Patients With Stage 2 Nasopharyngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT03068936
Recruitment Status : Not yet recruiting
First Posted : March 3, 2017
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University

Brief Summary:

Nasopharyngeal carcinoma has high incidence in the southern China, especially in Guangdong Province. In the world, the standardized morbidity has reached 30/10 million in men while in women, about 13/10 million. At present, the incidence of nasopharyngeal carcinoma in China accounted for more than 80% of the world. The cancer-related deaths is in the eighth, which is a serious threat to our people's health and life. A recent multi-center phase II study of stage II nasopharyngeal carcinoma showed that: compared with Intensity Modulation Radiotherapy (IMRT) plus cisplatin, the 3 year local control rate, regional control rate, distant metastasis-free survival rate and disease-specific survival rate of IMRT were similar, but the side effects of radiotherapy alone group were lower.

Based on the results of the phase II clinical study, the investigators designed this phase III clinical study, with the aim to compared the efficacy and toxicity of these two treatment programs. And finally to provide sufficient evidence for the treatment of stage II nasopharyngeal carcinoma.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 716 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intensity Modulated Radiotherapy Plus Cisplatin Versus Intensity Modulated Radiotherapy in Patients With Stage 2 Nasopharyngeal Carcinoma: A Phase 3 Multicenter, Open-label, Randomized, Non-inferior Clinical Trial
Estimated Study Start Date : March 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arm Intervention/treatment
Experimental: IMRT group
Intensity modulated radiotherapy once a day, 5 times a week, continuous treatment for about 6 weeks (DT 70Gy)
Radiation: Intensity modulated radiotherapy
Intensity modulated radiotherapy once a day, 5 times a week, continuous treatment for about 6 weeks (DT 70Gy)
Other Name: IMRT

IMRT plus cisplatin group
Intensity modulated radiotherapy once a day, 5 times a week, continuous treatment for about 6 weeks (DT 70Gy),plus synchronous cisplatin (100mg / m2 / times) chemotherapy, once every 3 weeks, a total of 2 times
Radiation: Intensity modulated radiotherapy
Intensity modulated radiotherapy once a day, 5 times a week, continuous treatment for about 6 weeks (DT 70Gy)
Other Name: IMRT

Drug: Cisplatin
Synchronous cisplatin (100mg / m2 / times) chemotherapy, once every 3 weeks, a total of 2 times




Primary Outcome Measures :
  1. Overall survival rate [ Time Frame: up to 3 years ]
    Refers to the time from included to death due to any cause.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The sex of the subject is not limited, the age is from 18 to 70 years old;
  • Histologically proven nasopharyngeal squamous cell carcinoma, World Health Organization (WHO) II-III type;
  • Union Internationale Contre le Cancer(UICC) stage 9 clinical stage II patients;
  • Karnofsky score ≥ 80 points;
  • No evidence of distant metastasis;
  • Having an nasopharyngeal MRI before treatment ,which can measure the size of the tumor in order to analyze the effect.

Exclusion Criteria:

  • The subject had previously suffered from other malignancies (except non-melanotic skin cancer or cervical carcinoma in situ);
  • Previously received immunotherapy;
  • Previously received chemotherapy;
  • Previously received radiation therapy;
  • Patients who had previously undergone surgical treatment for head and neck tumors (excluding cervical lymphadenectomy);
  • Evidence of distant metastases or other malignancies at the same time.

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): NCT03068936


Contacts
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Contact: Dehua Wu 18602062748 18602062748@163.com

Sponsors and Collaborators
Nanfang Hospital of Southern Medical University

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Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03068936     History of Changes
Other Study ID Numbers: C1033400
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nanfang Hospital of Southern Medical University:
Nasopharyngeal Carcinoma
Intensity modulated radiotherapy
Cisplatin

Additional relevant MeSH terms:
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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
Carcinoma
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cisplatin
Antineoplastic Agents