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Radiotherapy Combine With Raltitrexed Versus Radiotherapy Alone in Older Patients With HNSCC.

5. august 2020 opdateret af: Lv Xiupeng, The First Affiliated Hospital of Dalian Medical University

Radiotherapy Combine With Raltitrexed Versus Radiotherapy Alone in Older Patients With Head and Neck Squamous Cell Carcinoma: a Prospective Randomized Controlled Trial

The purpose of this study is to evaluate the efficacy of radiotherapy combine with raltitrexed in older patients with head and neck squamous cell carcinoma.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Radiotherapy play a critical role in the treatment of head and neck squamous cell carcinoma. Concurrent chemoradiotherapy can increased patients' survival rate. Most of head and neck squamous cell carcinoma patients are in the age range from 60 to 80 years old. Head and neck cancer begin in concealed anatomic sites that make it difficult to found the disease. Therefore, a larger proportion of patients diagnosed with cancer at a late stage.The tissues of head and neck are closely related to important functions such as respiratory, swallowing. Therefore patients are often accompanied by poor nutritional status, cardiac dysfunction and other chronic diseases.Since the tumor is extensive and it cannot be completely resected.These patients are not suitable for surgery alone. Radical radiotherapy or adjuvant radiotherapy is often administered. In order to increase the treatment efficacy, patients with high risk are commonly treated with concurrent chemoradiotherapy. Concurrent chemoradiotherapy often cause serious side effects. For older patients who often have chronic health conditions or poor ECOG(Eastern Cooperative Oncology Group) score are difficult to tolerate.It is crucial to enhance the efficacy of treatment of head and neck squamous cell carcinoma in older patients without causing significant side effect.

Raltitrexed is a direct and specific thymidylate synthase (TS) inhibitor and it is an alternative option for patients unsuitable for cisplatin based chemoradiotherapy. It is more suitable for the treatment of head and neck squamous cell carcinoma in older patients. It is deserved to further investigation. Researches indicated that raltitrexed has shown efficacy and good safety profile in the treatment of colorectal cancer.

It is rarely reported that intensity modulated radiotherapy plus raltitrexed in the treatment of patients with head and neck squamous cell carcinoma,particularly in older patients.The aim of this study was to compare the efficacy of intensity modulated radiotherapy plus raltitrexed with intensity modulated radiotherapy alone in older patients with squamous cell carcinoma of the head and neck.

According to EORTC(European Organization for Research on Treatment of Cancer)22931 study, The 2-year PFS(progression-free survival) was 48% with chemotherapy alone in squamous cell carcinoma of the head and neck. Planting A et al studied raltitrexed at escalating doses combine with radiotherapy in locally advanced head and neck cancer. The results showed that 12 out of 17 patients remained free of locoregional recurrence after a median follow-up of 24(+) months (range 3-60+ months).The study was designed to detect a 15-20% clinic benefit for patients, using α of 0.05 and a β of 0.20. To achieve this, the number of patients required was 101 per group, according to drup-out rate 10%.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

202

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Liaoning
      • Dalian, Liaoning, Kina, 116000
        • Rekruttering
        • Lv Xiupeng
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Before participate in the study, patients must understand the treatment plan and willing to participate in the study. Patients must have signed an approved informed consent.
  2. Histopathologic confirmed squamous cell carcinoma of head and neck ,including oral cavity, oropharynx, larynx, or hypopharynx.
  3. Ages≥65 years,Not limited to gender.
  4. ECOG performance status ≤2.
  5. Patients with surgical contraindication or reject to surgery.
  6. Postoperative TNM(primary tumor,regional nodes,metastasis) staging III~IV, positive surgical margin.
  7. without evidence of distant metastases.
  8. No contraindication to chemoradiotherapy.
  9. Life expectancy > 3 months.
  10. Available Organ function: white blood cell≥3.5×109/L, Neutrophils ≥1.5×109/L, Hemoglobin ≥80g/L, Blood platelet>100×109/L; Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST)≤ 2.5 upper limit of normal(ULN); Total bilirubin (TBIL) <1.5 ULN;serum creatinine≤1.5 ULN; creatinine clearance of ≥ 50ml/min

Exclusion Criteria:

  1. Patients with a history of any other malignancy.
  2. Concomitant treatment with any other anticancer therapy.
  3. Patient have contraindication to chemotherapy(eg.uncontrolled coronarism and heart failure; History of myocardial infarction within the past 6 months, Chronic obstructive pulmonary, uncontrolled epileptic attack and other disease that investigator consider it unsuitable for the chemotherapy)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Raltitrexed plus Radiation
Raltitrexed 2.5mg/m2, iv, every 3 weeks, concurrently with intensity modulated radiotherapy(IMRT)
Medicin: Raltitrexed
Raltitrexed 2.5mg/m2 on day 1,22,43 during radiotherapy
Stråling: Intensity Modulated Radiotherapy
Radical radiotherapy:70Gy/2Gy/7 weeks Preoperative and postoperative adjuvant radiotherapy:50-60Gy/2Gy/5-6 week
Aktiv komparator: Radiation
Intensity modulated radiotherapy(IMRT) alone radical radiotherapy:70Gy/2Gy/7 weeks preoperative and postoperative adjuvant radiotherapy:50-60Gy/2Gy/5-6 weeks
Stråling: Intensity Modulated Radiotherapy
Radical radiotherapy:70Gy/2Gy/7 weeks Preoperative and postoperative adjuvant radiotherapy:50-60Gy/2Gy/5-6 week

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
PFS，Progress Free Survival
Tidsramme: 2 years
Progress free survival defined as time from the first day of treatment until disease progress or death
2 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Treatment-Emergent Adverse Events
Tidsramme: 2 years
Treatment-Emergent Adverse Event is defined according to CTCAE(Common Terminology Criteria for Adverse Events) v.4.0. All the adverse reactions and serious adverse reactions will be recorded based on laboratory tests, physical examination, ECOG performance status, electrocardiogram and etc. And then will be graded according to CTCAE v.4.0.
2 years
OS，Overall Survival
Tidsramme: 2 years
Overall survival was defined as time from diagnosis until either death as a result of any cause. For patients who loss to follow-up before death, defined the last follow-up time as the death time
2 years
DCR，Disease Control Rate
Tidsramme: 2 years
according to RECIST criterion, defined as CR(complete response) + PR(partial reponse) + SD(stable disease)
2 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The First Affiliated Hospital of Dalian Medical University

Datoer for undersøgelser

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Studer store datoer

Studiestart (Faktiske)

1. september 2017

Primær færdiggørelse (Forventet)

1. august 2020

Studieafslutning (Forventet)

1. august 2023

Datoer for studieregistrering

Først indsendt

11. juni 2017

Først indsendt, der opfyldte QC-kriterier

21. juni 2017

Først opslået (Faktiske)

23. juni 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. august 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. august 2020

Sidst verificeret

1. august 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LCKY2016-65

Plan for individuelle deltagerdata (IPD)

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