- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02573506
Study of Split-course Chemoradiotherapy For Locally Advanced None-small Cell Lung Cancer
A Prospective Phase Ⅱ Study of Split-course Chemoradiotherapy For Locally Advanced None-small Cell Lung Cancer
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
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Guangdong
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Guangzhou, Guangdong, Čína, 510000
- Hui Liu
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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.
Souběžná chemoterapie sestává z týdenního podávání docetaxelu (25 mg/㎡) a nedaplatiny (25 mg/㎡), přičemž každá trvá 1 den.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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přežití bez progrese
Časové okno: 3 roky
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3 roky
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Celkové přežití
Časové okno: 3 roky
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3 roky
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Rychlost odezvy
Časové okno: 3 roky
|
3 roky
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rychlost radiační ezofagitidy stupně 3-4
Časové okno: 1 rok
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1 rok
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rychlost radiační pneumonitidy 3.-4. stupně
Časové okno: 1 rok
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1 rok
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Hui Liu, Doctor, Sun yat-sen universtiy cancer center
Publikace a užitečné odkazy
Obecné publikace
- Fu KK, Pajak TF, Trotti A, Jones CU, Spencer SA, Phillips TL, Garden AS, Ridge JA, Cooper JS, Ang KK. A Radiation Therapy Oncology Group (RTOG) phase III randomized study to compare hyperfractionation and two variants of accelerated fractionation to standard fractionation radiotherapy for head and neck squamous cell carcinomas: first report of RTOG 9003. Int J Radiat Oncol Biol Phys. 2000 Aug 1;48(1):7-16. doi: 10.1016/s0360-3016(00)00663-5.
- Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomised clinical trials. Non-small Cell Lung Cancer Collaborative Group. BMJ. 1995 Oct 7;311(7010):899-909.
- Albain KS, Swann RS, Rusch VW, Turrisi AT 3rd, Shepherd FA, Smith C, Chen Y, Livingston RB, Feins RH, Gandara DR, Fry WA, Darling G, Johnson DH, Green MR, Miller RC, Ley J, Sause WT, Cox JD. Radiotherapy plus chemotherapy with or without surgical resection for stage III non-small-cell lung cancer: a phase III randomised controlled trial. Lancet. 2009 Aug 1;374(9687):379-86. doi: 10.1016/S0140-6736(09)60737-6. Epub 2009 Jul 24.
- Schild SE, McGinnis WL, Graham D, Hillman S, Fitch TR, Northfelt D, Garces YI, Shahidi H, Tschetter LK, Schaefer PL, Adjei A, Jett J. Results of a Phase I trial of concurrent chemotherapy and escalating doses of radiation for unresectable non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2006 Jul 15;65(4):1106-11. doi: 10.1016/j.ijrobp.2006.02.046. Epub 2006 May 26.
- Auperin A, Le Pechoux C, Rolland E, Curran WJ, Furuse K, Fournel P, Belderbos J, Clamon G, Ulutin HC, Paulus R, Yamanaka T, Bozonnat MC, Uitterhoeve A, Wang X, Stewart L, Arriagada R, Burdett S, Pignon JP. Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer. J Clin Oncol. 2010 May 1;28(13):2181-90. doi: 10.1200/JCO.2009.26.2543. Epub 2010 Mar 29.
- Bradley JD, Paulus R, Komaki R, Masters G, Blumenschein G, Schild S, Bogart J, Hu C, Forster K, Magliocco A, Kavadi V, Garces YI, Narayan S, Iyengar P, Robinson C, Wynn RB, Koprowski C, Meng J, Beitler J, Gaur R, Curran W Jr, Choy H. Standard-dose versus high-dose conformal radiotherapy with concurrent and consolidation carboplatin plus paclitaxel with or without cetuximab for patients with stage IIIA or IIIB non-small-cell lung cancer (RTOG 0617): a randomised, two-by-two factorial phase 3 study. Lancet Oncol. 2015 Feb;16(2):187-99. doi: 10.1016/S1470-2045(14)71207-0. Epub 2015 Jan 16.
- Tsujino K, Kurata T, Yamamoto S, Kawaguchi T, Kubo A, Isa S, Hasegawa Y, Ou SH, Takada M, Ando M. Is consolidation chemotherapy after concurrent chemo-radiotherapy beneficial for patients with locally advanced non-small-cell lung cancer? A pooled analysis of the literature. J Thorac Oncol. 2013 Sep;8(9):1181-9. doi: 10.1097/JTO.0b013e3182988348.
- Steel GG, Hill RP, Peckham MJ. Combined radiotherapy--chemotherapy of Lewis lung carcinoma. Int J Radiat Oncol Biol Phys. 1978 Jan-Feb;4(1-2):49-52. doi: 10.1016/0360-3016(78)90114-1. No abstract available.
- Marino P, Preatoni A, Cantoni A. Randomized trials of radiotherapy alone versus combined chemotherapy and radiotherapy in stages IIIa and IIIb nonsmall cell lung cancer. A meta-analysis. Cancer. 1995 Aug 15;76(4):593-601. doi: 10.1002/1097-0142(19950815)76:43.0.co;2-n.
- Pritchard RS, Anthony SP. Chemotherapy plus radiotherapy compared with radiotherapy alone in the treatment of locally advanced, unresectable, non-small-cell lung cancer. A meta-analysis. Ann Intern Med. 1996 Nov 1;125(9):723-9. doi: 10.7326/0003-4819-125-9-199611010-00003. Erratum In: Ann Intern Med 1997 Apr 15;126(8):670.
- Kubota K, Furuse K, Kawahara M, Kodama N, Yamamoto M, Ogawara M, Negoro S, Masuda N, Takada M, Matsui K, et al. Role of radiotherapy in combined modality treatment of locally advanced non-small-cell lung cancer. J Clin Oncol. 1994 Aug;12(8):1547-52. doi: 10.1200/JCO.1994.12.8.1547.
- Clinical practice guidelines for the treatment of unresectable non-small-cell lung cancer. Adopted on May 16, 1997 by the American Society of Clinical Oncology. J Clin Oncol. 1997 Aug;15(8):2996-3018. doi: 10.1200/JCO.1997.15.8.2996.
- Curran WJ, Scott C, Langer C, et al. Phase III comoarision of sequential vs concurrent chemoradiation therapy for patients with unresectable stage III non-small cell lung cancer: initial report of RTOG 9410. Proc Am Soc Clin Oncol, 2000, 19: 484a
- Furuse K, Fukuoka M, Kawahara M, Nishikawa H, Takada Y, Kudoh S, Katagami N, Ariyoshi Y. Phase III study of concurrent versus sequential thoracic radiotherapy in combination with mitomycin, vindesine, and cisplatin in unresectable stage III non-small-cell lung cancer. J Clin Oncol. 1999 Sep;17(9):2692-9. doi: 10.1200/JCO.1999.17.9.2692.
- Pfister DG, Johnson DH, Azzoli CG, Sause W, Smith TJ, Baker S Jr, Olak J, Stover D, Strawn JR, Turrisi AT, Somerfield MR; American Society of Clinical Oncology. American Society of Clinical Oncology treatment of unresectable non-small-cell lung cancer guideline: update 2003. J Clin Oncol. 2004 Jan 15;22(2):330-53. doi: 10.1200/JCO.2004.09.053. Epub 2003 Dec 22. No abstract available.
- Ardizzoni A, Boni L, Tiseo M, Fossella FV, Schiller JH, Paesmans M, Radosavljevic D, Paccagnella A, Zatloukal P, Mazzanti P, Bisset D, Rosell R; CISCA (CISplatin versus CArboplatin) Meta-analysis Group. Cisplatin- versus carboplatin-based chemotherapy in first-line treatment of advanced non-small-cell lung cancer: an individual patient data meta-analysis. J Natl Cancer Inst. 2007 Jun 6;99(11):847-57. doi: 10.1093/jnci/djk196.
- Blackstock AW, Socinski MA, Bogart J, et al; Cancer and Leukemia Group B. Induction plus concurrent chemotherapy with high-dose (74 Gy) 3-dimensional (3-D) thoracic radiotherapy in stage III non-small cell lung cancer. Preliminary report of Cancer and Leukemia Group B (CALGB) 30105. Proc Am Soc Clin Oncol 2006;24(18S):Abstr 7042
- Lee CB, Socinski A, Lin L, et al. High-dose 3D chemoradiotherapy in stage III non-small cell lung cancer (NSCLC) at the University of North Carolina: long-term follow up and late complications. Proc Am Soc Clin Oncol 2006;24(18S):Abstr 7145.
- Kong FM, Ten Haken RK, Schipper MJ, Sullivan MA, Chen M, Lopez C, Kalemkerian GP, Hayman JA. High-dose radiation improved local tumor control and overall survival in patients with inoperable/unresectable non-small-cell lung cancer: long-term results of a radiation dose escalation study. Int J Radiat Oncol Biol Phys. 2005 Oct 1;63(2):324-33. doi: 10.1016/j.ijrobp.2005.02.010.
- Spoelstra FO, Pantarotto JR, van Sornsen de Koste JR, Slotman BJ, Senan S. Role of adaptive radiotherapy during concomitant chemoradiotherapy for lung cancer: analysis of data from a prospective clinical trial. Int J Radiat Oncol Biol Phys. 2009 Nov 15;75(4):1092-7. doi: 10.1016/j.ijrobp.2008.12.027. Epub 2009 Mar 26.
- 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.
- Belani CP, Choy H, Bonomi P, Scott C, Travis P, Haluschak J, Curran WJ Jr. Combined chemoradiotherapy regimens of paclitaxel and carboplatin for locally advanced non-small-cell lung cancer: a randomized phase II locally advanced multi-modality protocol. J Clin Oncol. 2005 Sep 1;23(25):5883-91. doi: 10.1200/JCO.2005.55.405. Epub 2005 Aug 8. Erratum In: J Clin Oncol. 2006 Apr 20;24(12):1966.
- Curran W, Scott C, Langer C, et al. Phase III comparison of sequential vs concurrent chemoradiotherapy for patients (pts) with unresected stage III non-small cell lung cancer (NSCLC): report of Radiation Therapy Oncology Group (RTOG) 9410. Proc Am Soc Clin Oncol 2003;22:Abstr 2499.
- Vokes EE, Herndon JE 2nd, Kelley MJ, Cicchetti MG, Ramnath N, Neill H, Atkins JN, Watson DM, Akerley W, Green MR; Cancer and Leukemia Group B. Induction chemotherapy followed by chemoradiotherapy compared with chemoradiotherapy alone for regionally advanced unresectable stage III Non-small-cell lung cancer: Cancer and Leukemia Group B. J Clin Oncol. 2007 May 1;25(13):1698-704. doi: 10.1200/JCO.2006.07.3569. Epub 2007 Apr 2.
- Hanna N, Neubauer M, Yiannoutsos C, McGarry R, Arseneau J, Ansari R, Reynolds C, Govindan R, Melnyk A, Fisher W, Richards D, Bruetman D, Anderson T, Chowhan N, Nattam S, Mantravadi P, Johnson C, Breen T, White A, Einhorn L; Hoosier Oncology Group; US Oncology. Phase III study of cisplatin, etoposide, and concurrent chest radiation with or without consolidation docetaxel in patients with inoperable stage III non-small-cell lung cancer: the Hoosier Oncology Group and U.S. Oncology. J Clin Oncol. 2008 Dec 10;26(35):5755-60. doi: 10.1200/JCO.2008.17.7840. Epub 2008 Nov 10.
- Segawa Y, Kiura K, Takigawa N, Kamei H, Harita S, Hiraki S, Watanabe Y, Sugimoto K, Shibayama T, Yonei T, Ueoka H, Takemoto M, Kanazawa S, Takata I, Nogami N, Hotta K, Hiraki A, Tabata M, Matsuo K, Tanimoto M. Phase III trial comparing docetaxel and cisplatin combination chemotherapy with mitomycin, vindesine, and cisplatin combination chemotherapy with concurrent thoracic radiotherapy in locally advanced non-small-cell lung cancer: OLCSG 0007. J Clin Oncol. 2010 Jul 10;28(20):3299-306. doi: 10.1200/JCO.2009.24.7577. Epub 2010 Jun 7.
- Davies AM, Chansky K, Lau DH, Leigh BR, Gaspar LE, Weiss GR, Wozniak AJ, Crowley JJ, Gandara DR; SWOG S9712. Phase II study of consolidation paclitaxel after concurrent chemoradiation in poor-risk stage III non-small-cell lung cancer: SWOG S9712. J Clin Oncol. 2006 Nov 20;24(33):5242-6. doi: 10.1200/JCO.2006.07.0268.
- Saunders M, Dische S, Barrett A, Harvey A, Griffiths G, Palmar M. Continuous, hyperfractionated, accelerated radiotherapy (CHART) versus conventional radiotherapy in non-small cell lung cancer: mature data from the randomised multicentre trial. CHART Steering committee. Radiother Oncol. 1999 Aug;52(2):137-48. doi: 10.1016/s0167-8140(99)00087-0.
- Petereit DG, Sarkaria JN, Chappell R, Fowler JF, Hartmann TJ, Kinsella TJ, Stitt JA, Thomadsen BR, Buchler DA. The adverse effect of treatment prolongation in cervical carcinoma. Int J Radiat Oncol Biol Phys. 1995 Jul 30;32(5):1301-7. doi: 10.1016/0360-3016(94)00635-X.
- Begg AC, Hofland I, Van Glabekke M, et al. Predictive value of potential doubling time for radiotherapy of head and neck tumor pa- tients: results from the EORTC cooperative trial 22851. Semin Radiat Oncol 1992;2:22-25
- Kim YS, Choi EK, Lee JS et al. Consolidation chemotherapy with monthly Paclitaxel and Cisplatin (PC) or observation after concurrent chemoradiotherapy for locally advanced non-small cell lung cancer (NSCLS): randomized phase II study. J Thorac Oncol 2007; 2:449s.
- Huber R, M, Engel-Riedel W, Kollmeier J et al. GILT study: oral vinorel- bine (NVBo) and cisplatin (P) with concomitant radiotherapy (RT) fol- lowed by either consolidation (C) with NVBo plus P plus best supportive care (BSC) or BSC alone in stage (st) III non-small cell lung cancer (NSCLC): final results of a phase (ph) III study. J Clin Oncol 2012;30: 452s (suppl, abstr 7001).
- Ahn JS, Ahn YC, Kim JH, Lee CG, Cho EK, Lee KC, Chen M, Kim DW, Kim HK, Min YJ, Kang JH, Choi JH, Kim SW, Zhu G, Wu YL, Kim SR, Lee KH, Song HS, Choi YL, Sun JM, Jung SH, Ahn MJ, Park K. Multinational Randomized Phase III Trial With or Without Consolidation Chemotherapy Using Docetaxel and Cisplatin After Concurrent Chemoradiation in Inoperable Stage III Non-Small-Cell Lung Cancer: KCSG-LU05-04. J Clin Oncol. 2015 Aug 20;33(24):2660-6. doi: 10.1200/JCO.2014.60.0130. Epub 2015 Jul 6.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- GASTO1011
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