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Reduced-dose Radiotherapy for Low-risk Stage III Patients With Nasopharyngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT03668730
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Hai-Qiang Mai,MD,PhD, Sun Yat-sen University

Brief Summary:
To study the 2-year PFS (progression-free survival) of patients with stage III nasopharyngeal carcinoma of pretreatment EBV DNA<4000 copy/ml treated with induction chemotherapy followed by two different doses of intensity-modulated radiation therapy and cisplatin.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Radiation: Intensity-modulated radiation therapy Drug: Paclitaxel liposome Drug: Cisplatin Drug: 5-Fluorouracil Phase 2

Detailed Description:

To explore the 2 year PFS of patients with stage III nasopharyngeal carcinoma of pretreatment EBV DNA<4000 copy/ml treated with induction chemotherapy followed by reduced-dose radiation and cisplatin. The enrolled patients will receive 2 cycles of TPF regimen induction chemotherapy, if radiographic CR/PR and EBV DNA=0 after induction chemotherapy, the patients will be delivered by 60 Gy IMRT combined with 3 cycles of cisplatin concurrent chemotherapy. If radiographic SD/PD or EBV DNA>0 after induction chemotherapy, the patients will receive a total of 70 Gy IMRT combined with 3 cycles of cisplatin concurrent chemotherapy.

The included patients will be treated with 2 cycles of TPF regimen induction chemotherapy and 60Gy IMRT combined with cisplatin concurrent chemotherapy. The TPF regimen is consist of paclitaxel liposome 135mg/m2 d1, cisplatin 25mg/m2d1-d3 and 5-Fu 3750mg/m2 civ120h, with a total of two cycles. Concurrent cisplatin chemotherapy is delivered with dose of 100mg/m2, a total of three cycles. The third cycle of cisplatin concurrent chemotherapy is allowed to be delivered within one week after IMRT finished.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Induction Chemotherapy Followed by Cisplatin With Low Dose vs. Standard Dose IMRT in Stage III Nasopharyngeal Carcinoma Patients With Pretreatment EBV DNA<4000 Copy/ml
Actual Study Start Date : November 19, 2018
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arm Intervention/treatment
Experimental: Reduced dose group
After 2 cycles of induction chemotherapy with Paclitaxel Liposome, Cisplatin and 5-Fluorouracil, patients undergo low-dose intensity-modulated radiotherapy (IMRT) 5 days per week for approximately 6 weeks (30 fractions). Patients also receive cisplatin once per three week for 3 cycles.
Radiation: Intensity-modulated radiation therapy
Patients undergo low-dose OR standard dose IMRT based on their radiographic response to induction chemotherapy

Drug: Paclitaxel liposome
Patients receive Paclitaxel liposome by 135mg/m2 with a total of two cycles.

Drug: Cisplatin
Patients receive Cisplatin by 25mg/m2 on day1-day3 with a total of two cycles as induction chemotherapy ; patients receive cisplatin by 100mg/m2 with a total of three cycles as concurrent chemotherapy.

Drug: 5-Fluorouracil
Patients receive 5-Fluorouracil by 3750mg/m2 civ120h with a total of three cycles.

Experimental: Standard dose group
After 2 cycles of induction chemotherapy with Paclitaxel Liposome,Cisplatin and 5-Fluorouracil, patients undergo standard-dose intensity-modulated radiotherapy (IMRT) 5 days per week for approximately 6 weeks (33 fractions). Patients also receive cisplatin once per three week for 3 cycles.
Radiation: Intensity-modulated radiation therapy
Patients undergo low-dose OR standard dose IMRT based on their radiographic response to induction chemotherapy

Drug: Paclitaxel liposome
Patients receive Paclitaxel liposome by 135mg/m2 with a total of two cycles.

Drug: Cisplatin
Patients receive Cisplatin by 25mg/m2 on day1-day3 with a total of two cycles as induction chemotherapy ; patients receive cisplatin by 100mg/m2 with a total of three cycles as concurrent chemotherapy.

Drug: 5-Fluorouracil
Patients receive 5-Fluorouracil by 3750mg/m2 civ120h with a total of three cycles.




Primary Outcome Measures :
  1. PFS(progression free survival) [ Time Frame: 2 years ]
    Defined from date of registration to date of first documentation of progression and/or distant metastasis,or death due to any cause. The primary study population for this endpoint is patients who were confirmed post-induction CR /PR and EBV DNA=0 and subsequently received 60Gy radiation therapy.


Secondary Outcome Measures :
  1. Overall Survival(OS) [ Time Frame: 2 years ]
    Defined from date of registration to date of first documentation of death from any cause or censored at the date of the last follow-up.

  2. Locoregional relapse-free survival(LRFS) [ Time Frame: 2 years ]
    Defined from date of registration to date of first documentation of locoregional relapse or until the date of the last follow-up visit.

  3. Distant metastasis-free survival(DMFS) [ Time Frame: 2 years ]
    Defined from date of registration to date of first documentation of distant metastases or until the date of the last follow-up visit.

  4. Overall response rate [ Time Frame: 2 years ]
    Tumour response rate was classified according to RECIST, version 1.1

  5. Incidence of acute toxicity [ Time Frame: 2 years ]
    Numbers of patients of treatment-related adverse events as assessed by CTCAE v4.0.

  6. Incidence of late toxicity [ Time Frame: 2 years ]
    Numbers of patients of late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme.

  7. Change of ADC( apparent diffusion coefficient ) value of DWI(Diffusion-Weighted MRI) of patients predictive of failure [ Time Frame: 2 years ]
    The ADC value of each patient of Diffusion-Weighted MRI at pretreatment and after induction chemotherapy was calculated were evaluated independently on a work station.

  8. Change of QoL [ Time Frame: 1 years ]
    QoL scores were assessed for each scale by using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30) before induction chemotherapy, before radiotherapy, at the end of radiotherapy, at 3 months after radiotherapy, at 6 months after radiotherapy and 12 months after radiotherapy.

  9. Change of EORTC quality of life questionnaire(QLQ) Head and Neck score [ Time Frame: 1 years ]
    QoL scores were assessed by using EORTC quality of life questionnaire(QLQ) Head and Neck. The QLQ-H&N35 is composed of seven multi-item symptom scales (pain, swallowing, sensation, speech, eating from a social,perspective, social interactions, and sexuality) and 11 single-item symptom scales (teeth, opening mouth,dry mouth, sticky saliva, coughing, felt ill, pain medication use, nutritional supplementation, feeding tube requirement, weight loss, and weight gain). All of the scales and items ranged in score from 0 to 100. A high score for a functional or global QoL scale represents a relatively high/healthy level of functional or global QoL, whereas a high score for a symptom scale or item represents a high number of symptoms or problems.

  10. Plasma EBV DNA copy number [ Time Frame: 2 years ]
    Plasma EBV DNA copy number with either reduced or standard dose radiotherapy was assessed by qRT-PCR at pretreatment. The predictive value of plasma EBV DNA copy number was assessed by survival analysis.



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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:

  1. Pathological diagnosis of NPC(WHO II or III).
  2. Stage III(8thAJCC/UICC staging system) and pretreatment EBVDNA<4000opies/ml.
  3. Aged 18—70 years。
  4. ECOG = 0-1。
  5. HGB≥90 g/L,WBC≥4×109 /L,PLT≥100×109 /L.
  6. ALT,AST<2.5 fold of ULN;TBIL<2.0×ULN。
  7. CCR≥60ml/min or Cr<1.5×ULN。
  8. Signed informed consent

Exclusion Criteria:

  1. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
  2. Age <18 or >70years.
  3. Treatment with palliative intent.
  4. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
  5. Pregnancy or lactation.
  6. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
  7. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
  8. 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): NCT03668730


Contacts
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Contact: Hai Qiang Mai, MD.PHD 020-87343380 maihq@sysucc.org.cn

Locations
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China, Guangdong
Hai Qiang Mai Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Hai Qiang Mai, MD.PHD    020-87343380    maihq@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Study Chair: Hai Qiang Mai, MD.PHD Sun Yat-sen University

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Responsible Party: Hai-Qiang Mai,MD,PhD, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03668730     History of Changes
Other Study ID Numbers: B2018-020-01
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hai-Qiang Mai,MD,PhD, Sun Yat-sen University:
nasopharyngeal carcinoma
IMRT
Radiation dose
induction chemotherapy
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
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Fluorouracil
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs