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A Phase II Trial of Cisplatin-Docetaxel Induction Plus Concurrent 3-D Conformal Radiotherapy and Weekly Chemotherapy (TAXCIS)

12. december 2017 opdateret af: Centre Antoine Lacassagne

Cisplatin-Docetaxel Induction Plus Concurrent 3-D Conformal Radiotherapy and Weekly Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer Patients: A Phase II Trial

Concurrent chemoradiotherapy (CHRT) is the standard of care for unresectable locally advanced stage III non-small cell lung cancer. However, the optimal combination remains unclear. The aim of this study is to evaluate the efficacy of 2 induction chemotherapy cycles (days 1 and 22) with docetaxel 75 mg/m2 and cisplatin 75 mg/m2 followed by concurrent chemotherapy (weekly docetaxel-cisplatin, 20 mg/m2) and 3-D conformal radiotherapy for 6 weeks (66 Gy/5 fractions per week/2 Gy per fraction). ). The primary endpoint is the response rate. Secondary objectives are toxicity, time to progression, and overall survival.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Lung cancer is the most common malignancy among men in most countries and constitutes the leading cause of cancer death worldwide. Non-small cell histology represents roughly 80% of lung cancer cases comprising one third of patients with stage III, locally-advanced disease at diagnosis. Some stage IIIA cancers are considered resectable but many stage IIIA (with bulky N2) and stage IIIB (T4 any N M0, any T N3M0) cancers are considered unsuitable for surgery. However, some authors have shown that surgery after chemoradiotherapy (CHRT) is beneficial for at least progression-free survival (PFS). Since the 90s, CHRT has become the cornerstone of inoperable locally advanced non-small cell lung cancer (NSCLC). A meta-analysis of 52 randomized studies showed a survival improvement of 3% at 2 years and 2% at 5 years for patients treated with CHRT versus radiotherapy alone [6]. Concomitant chemoradiation was demonstrated to be better than sequential administration in terms of overall survival (OS) in 3 out of 4 randomized studies with esophagitis as the dose-limiting toxicity. Nevertheless, the median survival was around 16 months and improvement is needed. To better control micrometastatic disease and reduce distant relapses, one possibility is to increase radiosensitization with higher doses of chemotherapy.The aim of this phase II study is to evaluate the anti-tumoral activity of a weekly docetaxel-cisplatin combination administered concurrently with radiotherapy after 2 induction cycles with the same drugs.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

44

Fase

  • Fase 2

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

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • histologically or cytologically confirmed NSCLC,
  • stage IIIB (excluding malignant pleural or pericardial effusions, tumoral volume exceeding one radiation field,
  • N3 supraclavicular, and contralateral hilar nodal involvement) or inoperable stage IIIA defined by the new International Staging System [21],
  • 18 ≤ age ≤ 75 years,
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤2,
  • weight loss <10%,
  • at least one measurable lesion according to RECIST 1.0 criteria,
  • adequate hematopoietic function (absolute neutrophil count ≥2 × 109/l, platelets ≥100 × 109/l, and hemoglobin level ≥10g/dl), adequate hepatic function [total serum bilirubin less than or equal to the institutional upper limit of normal (ULN), aspartate aminotransferase ≤1.5× ULN, and alkaline phosphatase ≤5× ULN], and adequate renal function (serum creatinine ≤1.5× ULN).

Exclusion Criteria:

  • patients previously treated with radiotherapy or chemotherapy for NSCLC,
  • previous cancer except basocellular carcinoma and in situ carcinoma of the cervix curatively treated and other cancers curatively treated for at least 5 years,
  • peripheral neuropathy NCI-CTC grade ≥2,
  • noncontroled severe disease,
  • pregnant or breast-feeding women.

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Radiochemotherapy
Induction chemotherapy with docetaxel and cisplatine and concomitant radiotherapy
Medicin: Docetaxel
Induction chemotherapy
Stråling: concomitant radiotherapy
Pulmonary and mediastinal radiotherapy
Medicin: Cisplatin
Induction chemotherapy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To evaluate the antitumor activity of Docetaxel - Cisplatin and concomitant thoracic radiotherapy after Docetaxel - Cisplatin induction chemotherapy in patients with locally advanced non-operable NSCLC by tumor response rate
Tidsramme: up to 3 years

Tumor Response rate between 6 and 8 weeks according to RECIST 1.0 criteria after the end of radiotherapy (except in the case of early progression) that patients:

  • having received at least 4 weekly injections of Docetaxel and Cisplatin,
  • who have received the full radiotherapy treatment (except in case of cessation for toxicity, in which case the patients will be evaluable).
up to 3 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall survival and at 12 months
Tidsramme: up to 3 years
To evaluate the overall survival at 12 months between the first day of treatment to the death
up to 3 years
Response delay
Tidsramme: up to 3 years
Complete response delay evaluated between the day of the complete response to the progression and partial response between the first day of the treatment and the progression
up to 3 years
Progression Free Survival
Tidsramme: up to 3 years
To evaluate Progression free survival according to RECIST criteria
up to 3 years
Tolerance profile of the association in terms of immediate and delayed toxicity
Tidsramme: up to 3 years
To evaluate early and late toxicity according to the NCI-CTC
up to 3 years
Quality of Life evaluation (EORTC QLQ-C30 and QLQ-LC13)
Tidsramme: up to 3 years
To evaluate the quality of life at inclusion, at the end oh chemotherapy, 2 months after the radiotherapy and every 3 months until end of study
up to 3 years

Samarbejdspartnere og efterforskere

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

Sponsor

Centre Antoine Lacassagne

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. august 2004

Primær færdiggørelse (Faktiske)

31. oktober 2010

Studieafslutning (Faktiske)

31. oktober 2011

Datoer for studieregistrering

Først indsendt

30. november 2017

Først indsendt, der opfyldte QC-kriterier

12. december 2017

Først opslået (Faktiske)

13. december 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. december 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. december 2017

Sidst verificeret

1. november 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2004/07

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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