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Two Cycles Versus Three Cyclle of CCRT for Low Risk Locoregionally Advanced Nasopharyngeal Carcinoma

8 novembre 2016 aggiornato da: Hai-Qiang Mai,MD,PhD, Sun Yat-sen University

A Randomized Phase II Non-inferiority Study of Two Cycles Versus Three Cycles of Cisplatin Based Concurrent Chemoradiotherapy for Low Risk Locoregionally Advanced Nasopharyngeal Carcinoma Based on Pretreatment Plasma EBV DNA Level

This is a Phase II trial to study the effectiveness of two cycles versus three cycles of Concurrent Chemoradiotherapy in treating patients with Low Risk Locoregionally Advanced Nasopharyngeal Carcinoma based on pretreatment plasma EBV DNA.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Nasopharyngeal carcinoma (NPC) is endemic in Southern China and Southeast Asia. Several prospective randomized trials have demonstrated that concurrent chemoradiotherapy was superior to radiotherapy alone in the treatment of locoregionally advanced NPC. Concurrently, although cisplatin-based concurrent chemoradiotherapy was considered as the standard regimen for locoregionally advanced nasopharyngeal carcinoma, several prospective randomized trials have demonstrated that only 52-63% patients can finished three cycles cisplatin-based concurrent chemoradiotherapy( DDP, 100mg/m2,D1,D22 and D43), due to chemoradiotherapy induced toxicity. Combined analyses of NPC-9901 and NPC-9902 Trials indicated that the 5-year locoregional failure free survival was insignificant between the patients received between two and three cycles cisplatin-based concurrent chemoradiotherapy. Our previous studies have also demonstrated that the five years overall survival, distant metastasis free survival and 5-year locoregional failure free survival was not observed significant difference between the patients received between two and three cycles cisplatin-based concurrent chemotherapy. It indicated that one pressing questions remain to be resolved: can we define the optimal dose so that we can reduce toxicity by avoiding unnecessary overdose or an ineffective phase of treatment? Recently, the quantification of pretreatment plasma Epstein-Barr virus (EBV) DNA, which was considered the most potential biomarker to compliment TNM stage, was demonstrated a useful biomarker for the risk stratification, monitoring and prediction of the prognosis of NPC. The investigators previous study demonstrated that for local and regionally advanced NPC patients with EBV DNA <4,000copies/mL, the 3-year's PFS and DMFS was approximate to 90%. Pretreatment plasma EBV DNA levels might be applied to guide concurrent chemotherapy regimen for local and regionally advanced NPC patients. Therefore, the investigators make a hypothesis that the low risk locoregionally advanced NPC patients received two cycles of chemotherapy may gain similar long-term survival as those received three cycles of chemotherapy, leading to less chemotherapy induced toxicity. Therefore, this phase II non-inferiority, randomised controlled clinical trial was designed to assess efficacy for low-risk patients, identified with pretreatment plasma EBV DNA <4,000 copies/mL, received two cycle cisplatin-based chemotherapy compared with three cycle cisplatin-based chemotherapy

Tipo di studio

Interventistico

Iscrizione (Anticipato)

236

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Cina
    • Guangdong
      • Guangzhou, Guangdong, Cina, 510060
        • Reclutamento
        • Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
  • Original clinical staged as T3-4N0-3 M0 or any T、N2-3M0（according to the 7th AJCC edition）
  • No evidence of distant metastasis (M0)
  • Pretreatment Plasm EB Virus DNA<4000copies/ml
  • Male and no pregnant female
  • Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1
  • WBC ≥ 4×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
  • With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 2.0×ULN)
  • With normal renal function test (Creatinine ≤ 1.5×ULN)

Exclusion Criteria:

  • Patients have evidence of relapse or distant metastasis
  • Histologically confirmed keratinizing squamous cell carcinoma (WHO I)
  • Receiving radiotherapy or chemotherapy previously
  • The presence of uncontrolled life-threatening illness
  • Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
  • Receiving other ways of anti-cancer therapy.
  • Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Two cycle CCRT
Concurrent cisplatin(100mg/m2,D1,D22)combine with IMRT
Droga: Cisplatin combine with IMRT
Concurrent cisplatin (100mg/m2，D1,D22) combine with IMRT
Altri nomi:
  • DDP
Droga: Cisplatin combine with IMRT
Concurrent cisplatin (100mg/m2，D1,D22 and D43) combine with IMRT
Altri nomi:
  • DDP
Comparatore attivo: Three cycle CCRT
Concurrent cisplatin(100mg/m2,D1,D22 and D43)combine with IMRT
Droga: Cisplatin combine with IMRT
Concurrent cisplatin (100mg/m2，D1,D22) combine with IMRT
Altri nomi:
  • DDP
Droga: Cisplatin combine with IMRT
Concurrent cisplatin (100mg/m2，D1,D22 and D43) combine with IMRT
Altri nomi:
  • DDP

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progress-free survival
Lasso di tempo: 3 years
Progress-free survival is calculated from the date of randomization to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up
3 years

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The shor-term toxic effects
Lasso di tempo: 3 months
The shorterm toxic effects were assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)
3 months
Complete Response (CR)
Lasso di tempo: after the completion of the chemoradiotherapy treatment (up to 9 weeks)
CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the chemoradiotherapy treatment. Complete response defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only
after the completion of the chemoradiotherapy treatment (up to 9 weeks)
Overall Survival(OS)
Lasso di tempo: 3 years
The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up
3 years
Locoregional Relapse-Free Survival(LRRFS)
Lasso di tempo: 3 years
The LRRFS is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit
3 years
Distant Metastasis-Free Survival (DMFS)
Lasso di tempo: 3 years
The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit
3 years
Cost-effectiveness analysis
Lasso di tempo: 3 years
The cost (including direct cost drug fees, inspection fees, expenses and nursing cost) and incremental cost-effectiveness ratio was calculated between two arms
3 years
The monitoring of plasma EBV DNA
Lasso di tempo: 3 years
The plasma EBV DNA will be detected before treatment ,during treatment (weekly) and during follow up( every 3-6 months)
3 years
Long-term toxicities
Lasso di tempo: 3 years
Patients will be monitored for long-term toxicity by standard NIH criteria. QoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30) and EORTC QLQ Head and Neck
3 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sun Yat-sen University

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 agosto 2016

Completamento primario (Anticipato)

1 luglio 2018

Completamento dello studio (Anticipato)

1 luglio 2021

Date di iscrizione allo studio

Primo inviato

17 luglio 2016

Primo inviato che soddisfa i criteri di controllo qualità

17 agosto 2016

Primo Inserito (Stima)

18 agosto 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

10 novembre 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 novembre 2016

Ultimo verificato

1 novembre 2016

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • cycle of CCRT and NPC

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INDECISO

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