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PET/CT-directed Hyperfractionated Radiation Dose Escalation in Stage III Non-small Cell Lung Cancer

1. maj 2019 opdateret af: Chen tingfeng, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Phase I Study of PET/CT-directed Hyperfractionated Radiation Dose Escalation With Concurrent Weekly Carboplatin and Paclitaxel in Stage III Non-small Cell Lung Cancer

The goal of this study is to find the maximum tolerable dose of radiation that can be delivered combined with chemotherapy (carboplatin & paclitaxel) in patients with stage III non-small cell lung cancer (NSCLC).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Concurrent chemoradiotherapy is the standard of care for unresectable stage III NSCLC based on the results of phase III randomised trials. The current standard radiation therapy dose has remained 60- Gy at -2 Gy/fraction for nearly four decades (60Gy), with local disease control rates of approximately 50% and a median overall survival of only 18 months.These results are suboptimal and more effective treatment regimens are needed.

We hypothesize that hyperfractionated radiation dose escalation to residual tumor volumes after standard chemoradiotherapy as defined by positron emission tomography (PET) /computed tomography (CT) would improve local control and overall survival while reducing the acute and late normal tissue toxicity.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

34

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Kina
      • Shanghai, Kina
        • the Ethic Committee of Shanghai General Hospital

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:

  1. Patients must have FDG-avid and histologically or cytologically proven non-small cell lung cancer.
  2. Age 1 8-75.
  3. Zubrod performance status 0-2.
  4. Stage III ( American Joint Committee on Cancer AJCC, 7th ed.).
  5. No prior radiation to the thorax that would overlap with the current treatment field.
  6. Adequate bone marrow, renal and hepatic functions as assessed by the following: Hemoglobin >/= 10.0 g/dl, Platelet count >/= 1 00,000/mm^3,absolute granulocyte count (AGC) ≥2 × 10^9 cells/L,bilirubin and Aspartate transaminase ≤1.5 ×upper limit of normal (ULN), Creatinine </=1 .5 times ULN.
  7. A signed informed consent must be obtained prior to therapy.
  8. Induction chemotherapy is allowed.
  9. Life expectancy more than 3 months.

Exclusion Criteria:

  1. Patients with any component of small cell lung carcinoma are excluded from this study.
  2. Patients with evidence of a malignant pleural or pericardial effusion are excluded.
  3. Prior radiotherapy that would overlap the radiation fields.
  4. Uncontrolled concurrent illness including, but not limited to: Chronic Obstructive Pulmonary Disease(COPD) exacerbation or other respiratory illness, serious uncontrolled infection, symptomatic congestive heart failure (CHF),unstable angina pectoris, uncontrolled hypertension,or psychiatric illness/social situations that would limit compliance with the study requirements.
  5. Known hypersensitivity to paclitaxel.
  6. Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study.
  7. Acquired Immune Deficiency Syndrome.
  8. Conditions precluding medical follow-up and protocol compliance.

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: Ikke-randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: radiochemotherapy 1
Patients will be treated with radiation therapy 64.8 Gy
Stråling: radiochemotherapy 1
concurrent radiochemotherapy: radiotherapy dose level 1: 60 Gy at 2 Gy/Fx/d, then 4.8 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly
Andre navne:
  • concurrent chemoradiotherapy regimen 1
Eksperimentel: radiochemotherapy 2
Patients will be treated with radiation therapy 69.6 Gy
Stråling: radiochemotherapy 2
concurrent radiochemotherapy: radiotherapy dose level 2: 60 Gy at 2 Gy/Fx/d, then 9.6 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly
Andre navne:
  • concurrent chemoradiotherapy regimen 2
Eksperimentel: radiochemotherapy 3
Patients will be treated with radiation therapy 74.4 Gy
Stråling: radiochemotherapy 3
concurrent radiochemotherapy: radiotherapy dose level 3: 60 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly
Andre navne:
  • concurrent chemoradiotherapy regimen 3
Eksperimentel: radiochemotherapy 4
Patients will be treated with radiation therapy 79.2 Gy
Stråling: radiochemotherapy 4
concurrent radiochemotherapy: radiotherapy dose level 4: 60 Gy at 2 Gy/Fx/d, then 19.2 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly
Andre navne:
  • concurrent chemoradiotherapy regimen 4
Eksperimentel: radiochemotherapy 5
Patients will be treated with radiation therapy 84 Gy
Stråling: radiochemotherapy 5
concurrent radiochemotherapy: radiotherapy dose level 5: 60 Gy at 2 Gy/Fx/d, then 4.8x5 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly
Andre navne:
  • concurrent chemoradiotherapy regimen 5
Eksperimentel: radiochemotherapy 6
Patients will be treated with radiation therapy 88.8 Gy
Stråling: radiochemotherapy 6
concurrent radiochemotherapy: radiotherapy dose level 6: 60 Gy at 2 Gy/Fx/d, then 4.8x6 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly
Andre navne:
  • concurrent chemoradiotherapy regimen 6
Eksperimentel: radiochemotherapy 7
Patients will be treated with radiation therapy 93.6 Gy
Stråling: radiochemotherapy 7
concurrent radiochemotherapy: radiotherapy dose level 7: 60 Gy at 2 Gy/Fx/d, then 4.8x7 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly
Andre navne:
  • concurrent chemoradiotherapy regimen 7

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum Tolerated Dose
Tidsramme: 1 year
Maximum Tolerated Dose is defined as CTCAE 4 grade 3 acute radiation-related toxicity
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to Local Failure
Tidsramme: 2 years
Local control will be assessed radiographically using endoscopy with biopsy and a positron emission computed tomography-CT scan
2 years

Samarbejdspartnere og efterforskere

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

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Efterforskere

  • Ledende efterforsker: tingfeng chen, MD, the ethic committee of shanghai genernal hospital

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)

2. januar 2017

Primær færdiggørelse (Faktiske)

30. juni 2018

Studieafslutning (Faktiske)

30. juni 2018

Datoer for studieregistrering

Først indsendt

28. marts 2017

Først indsendt, der opfyldte QC-kriterier

28. marts 2017

Først opslået (Faktiske)

4. april 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. maj 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. maj 2019

Sidst verificeret

1. marts 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SGH201708

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