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Reduced Target Delineation Chemoradiotherapy for Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT03389295
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To determine the efficacy and safety of sequential chemoradiotherapy with regimen of docetaxel, cisplatin and fluorouracil and reduced target delineation radiotherapy for patients with locoregionally advanced nasopharyngeal carcinoma

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Radiation: Reduced Target Delineation Phase 2

Detailed Description:
Although concurrent chemoradiation is the standard treatment modality for locally advanced nasopharyngeal carcinoma (NPC), high incidences of distant metastases and severe treatment related toxicities have become an obstacle to be overcome. Besides, a common problem in locally advanced NPC is the narrow gap between the tumor and critical normal structures, which makes dose optimization difficult. Considering that significant tumor shrinkage may occur during induction chemotherapy, and incidences of distant metastases may be reduced by adjuvant chemotherapy, this study was designed to explore the efficacy and safety of sequential chemoradiotherapy with regimen of docetaxel, cisplatin and fluorouracil and reduced target delineation radiotherapy for patients with locoregionally advanced NPC.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Drug: TPF regimen comprised docetaxel (60 mg/m2/day, day 1), cisplatin (25 mg/m2/day, days 1-3), and 5-fluorouracil (500 mg/m2/day with a 120-h infusion) Radiotherapy:Reduced Target Delineation
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sequential Chemoradiotherapy With Reduced Target Delineation During Radiotherapy for Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Actual Study Start Date : October 2014
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Reduced Target Delineation Chemoradiotherapy
All patients were assigned to receive induction chemotherapy (IC) followed by IMRT with adjuvant chemotherapy (AC). IMRT was administered 2 weeks after IC, and AC was administered 1 month after IMRT. IC or AC (TPF regimen) comprised docetaxel (60 mg/m2/day, day 1), cisplatin (25 mg/m2/day, days 1-3), and 5-fluorouracil (500 mg/m2/day with a 120-h infusion) administered once every 3 weeks for two cycles. During radiotherapy, involved retropharyngeal lymph nodes and intracavity lesions of the primary tumor were delineated according to the post-IC volume, whereas the remainder of the involved tissues (eg, pterygopalatine fossa) of the primary tumor were delineated according to the pre-IC volume of the primary tumor as shown by MRI. Post-IC volumes of involved neck lymph nodes were used for delineation.
Radiation: Reduced Target Delineation
The target volumes were delineated according to the treatment protocol defined as follows: the GTV of the primary tumor (GTV-P) included retropharyngeal lymph nodes, considering the common phenomena of integration, and the rest involved lymph nodes that were defined as GTV-N. For the GTV-P, involved retropharyngeal lymph nodes and intracavity lesions were delineated according to the post-IC volume, whereas the remainder of the involved tissues (eg, pterygopalatine fossa) were delineated according to the pre-IC volume of the primary lesion as shown by MRI. Post-IC volumes of involved neck lymph nodes were used for GTV-N delineation.
Other Name: Drug: TPF regimen comprised docetaxel (60 mg/m2/day, day 1), cisplatin (25 mg/m2/day, days 1-3), and 5-fluorouracil (500 mg/m2/day with a 120-h infusion)


Outcome Measures

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: up to 3 years ]
    The time from date of treatment until date of first documented disease progression or death from any cause, assessed up to 3 years.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: up to 3 years ]
    The time from date of treatment until date of death due to any cause, assessed up to 3 years.

  2. Locoregional recurrence-free survival [ Time Frame: up to 3 years ]
    The time from date of treatment until date of first documented disease recurrence at a locoregional site, assessed up to 3 years.

  3. Distant metastasis-free survival [ Time Frame: up to 3 years ]
    The time from date of treatment until date of first documented distant metastasis, assessed up to 3 years.

  4. Number of participants with hematologic toxicity events [ Time Frame: 1, 2 , 3 weeks post-dose ]
    Number of participants with hematologic toxicity events occurred during two cycles of induction and adjuvant chemotherapy according to CTCAE v4.

  5. Number of participants with acute toxicities [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks ]
    Number of participants with acute toxicities (hematologic toxicity events, oral mucositis, acne-like rash) occurred during the radiotherapy

  6. Number of participants with late toxicities [ Time Frame: up to 3 years ]
    Number of participants with late toxicities (hematologic toxicity events, dysphagia, acne-like rash or neurological toxicities) occurred from 3 months after completion of radiotherapy to last follow-up visit according to CTCAE v4.0

  7. Changes of tumor volume [ Time Frame: 2 weeks after completion of induction chemotherapy ]
    Changes of tumor volume before and after induction chemotherapy

  8. Relationship between treatment failure and dose received by target [ Time Frame: up to 3 years ]
    Relationship between treatment failure and dose received by target


Eligibility Criteria

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

Inclusion Criteria:

  1. Histopathologically proven nasopharyngeal carcinoma (WHO type 2 or 3)
  2. Stage Ⅲ-ⅣB disease (AJCC/UICC 2010)
  3. ECOG performance status of 0-1
  4. Life expectancy of more than 6 months
  5. Signed written informed consent
  6. Adequate organ function including the following:

Absolute neutrophil count (ANC) >= 1.5 * 109/l Platelets count >= 100 * 109/l Hemoglobin >= 10 g/dl AST and ALT <= 2.5 times institutional upper limit of normal (ULN) Total bilirubin <= 1.5 times institutional ULN Creatinine clearance >= 50 ml/min Serum creatine <= 1 times ULN

Exclusion Criteria:

  1. Evidence of distant metastasis
  2. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
  3. Other previous or concomitant cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
  4. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
  5. Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
Contacts and Locations

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): NCT03389295


Contacts
Contact: Xiayun He, MD +86-18017312167 hexiayun1962@163.com

Locations
China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Xiayun He, MD    +86-18017312167    hexiayun1962@163.com   
Contact: Fen Xue, MD    +86-18505123563    xuefen1992@126.com   
Sponsors and Collaborators
Xiayun He, MD
More Information

Responsible Party: Xiayun He, MD, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT03389295     History of Changes
Other Study ID Numbers: TPF-Shanghai
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017

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

Keywords provided by Xiayun He, MD, Fudan University:
Nasopharyngeal Carcinoma
Reduced Target Delineation
Sequential chemoradiotherapy

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Docetaxel
Cisplatin
Fluorouracil
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs