Study of Split-course Chemoradiotherapy For Locally Advanced None-small Cell Lung Cancer
10 april 2020 uppdaterad av: Hui Liu, Sun Yat-sen University
A Prospective Phase Ⅱ Study of Split-course Chemoradiotherapy For Locally Advanced None-small Cell Lung Cancer
This Phase II study is to determine the efficacy of split-course irradiation with concurrent chemotherapy in locally advanced none-small cell lung cancer patients.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This Phase II study is to determine the efficacy of split-course chemoradiotherapy(CCRT) in locally advanced non-small cell lung cancer.
Patients receive four cycles of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration, combined with split-course thoracic radiotherapy of 51 Gy/17 fractions and 15-18 Gy/5-6 fractions administered in the first and second courses, respectively, with about one-month break. The primary endpoint is progression-free survival, which is calculated from the start of RT to the first identification of disease progression or death. Progression-free survival will be calculated using the Kaplan-Meier method. Toxicities will be graded according to CTCAE V.4.0.
Studietyp
Interventionell
Inskrivning (Faktisk)
99
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Guangdong
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Guangzhou, Guangdong, Kina, 510000
- Hui Liu
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Pathologic confirmation of NSCLC.
- Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- Unresectable phase IIIA(N2) and IIIB lung cancer confirmed by PET/CT, CT or MRI.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Previously treated with chemotherapy or treatment-naive
- No previous chest radiotherapy, immunotherapy or biotherapy
- Hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL
- Serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min
- Bilirubin ≤1.5 times UNL, AST（SGOT）≤2.5 times UNL ,ALT（SGPT）≤2.5 times UNL,alkaline phosphatase ≤5 times UNL
- FEV1 >0.8 L
- CB6 within normal limits
- patients and their family signed the informed consents
Exclusion Criteria:
- Previous or recent another malignancy, except nonmelanoma skin cancer or cervical cancer in situ
- Contraindication for chemotherapy
- Malignant pleural or pericardial effusion.
- Women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose
- Women who has the probability of pregnancy without contraception
- Tendency of hemorrhage
- In other clinical trials within 30 days
- Addicted in drugs or alcohol, AIDS patients
- Uncontrollable seizure or psychotic patients without self-control ability
- Severe allergy or idiosyncrasy
- Not suitable for this study judged by researchers
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: split-course radiotherapy
The radiotherapy is delivered using simultaneous integrated boost (SIB)-IMRT.
Patients are irradiation at a palliative dose in the initial course: 51Gy/17f to PTV-GTV.
The disease is re-evaluated three weeks after the end of the initial course using CT.
The patient without disease progression according to the RECIST criteria and had a recovery of lung function should get the additional boost.
In the second course, the tumor is repositioned and scanned.
The residual tumor is then treated with the second course of radiotherapy.
A dose of 15-18 Gy/5-6f is delivered to the residue tumor.
Concurrent chemotherapy consists of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration.
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Patients are irradiation at a palliative dose in the initial course: 51Gy/17f to PTV-GTV.
The disease is re-evaluated three weeks after the end of the initial course using CT.
The patient without disease progression according to the RECIST criteria and had a recovery of lung function should get the additional boost.
In the second course, the tumor is repositioned and scanned.
The residual tumor is then treated with the second course of radiotherapy.
A dose of 15-18 Gy/5-6f is delivered to the residue tumor.
Samtidig kemoterapi består av docetaxel (25 mg/㎡) varje vecka och nedaplatin (25 mg/㎡), vardera med 1 dags varaktighet.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Progressionsfri överlevnad
Tidsram: 3 år
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3 år
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Sekundära resultatmått
Resultatmått |
Tidsram |
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Total överlevnad
Tidsram: 3 år
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3 år
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Svarsfrekvens
Tidsram: 3 år
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3 år
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frekvens av grad 3-4 strålningsesofagit
Tidsram: 1 år
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1 år
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graden av grad 3-4 strålningspneumonit
Tidsram: 1 år
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1 år
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Hui Liu, Doctor, Sun yat-sen universtiy cancer center
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
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- Gielda BT, Marsh JC, Zusag TW, Faber LP, Liptay M, Basu S, Warren WH, Fidler MJ, Batus M, Abrams RA, Bonomi P. Split-course chemoradiotherapy for locally advanced non-small cell lung cancer: a single-institution experience of 144 patients. J Thorac Oncol. 2011 Jun;6(6):1079-86. doi: 10.1097/JTO.0b013e3182199a7c.
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 augusti 2015
Primärt slutförande (Faktisk)
1 mars 2020
Avslutad studie (Faktisk)
1 mars 2020
Studieregistreringsdatum
Först inskickad
19 september 2015
Först inskickad som uppfyllde QC-kriterierna
8 oktober 2015
Första postat (Uppskatta)
9 oktober 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 april 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 april 2020
Senast verifierad
1 april 2020
Mer information
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Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- GASTO1011
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