Pre-operative Chemotherapy Versus Concurrent Chemoradiotherapy in N2 Positive IIIA Non Small Cell Lung Cancer (NSCLC)
9. juli 2010 opdateret af: National Cancer Center, Korea
A Randomized Phase II Study Preoperative Chemotherapy Versus Preoperative Concurrent Chemoradiotherapy for Patients With Biopsy-Proven N2 Stage IIIA Non-Small Cell Lung Cancer
It is suggested that a bimodal or trimodal approach combining neoadjuvant chemotherapy with or without radiotherapy followed by surgery provides a potentially superior method of enhancing resectability and improving locoregional control and survival compared to radiotherapy alone followed by surgery.
Unsolved questions are the identification of the best induction strategy, the impact of surgery on long-term survival, and the contribution of radiation therapy in this setting.
Thus, the investigators conduct a phase II trial to compare neoadjuvant chemotherapy with concurrent chemoradiotherapy in patients with biopsy proven N2 stage IIIA NSCLC to address optimal induction strategy.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Preoperative Therapy Arm 1. (preoperative chemotherapy) Paclitaxel (90 mg/m2)on day 1 and 8 Cisplatin (40 mg/m2)on day 1 and 8. q 3 weeks, 2 cycles
Arm 2. (preoperative chemoradiotherapy) Paclitaxel (50 mg/m2)on day 1, 8, 15, 22 & 29 Cisplatin (20 mg/m2)on day 1, 8, 15, 22 & 29. Thoracic radiation therapy (TRT) 1.8 Gy daily, five times per week (45 Gy target dose in 5 weeks).
Postoperative Consolidation Chemotherapy:
Paclitaxel (90 mg/m2) on day 1 and 8. Cisplatin (40 mg/m2) on day 1 and 8. q 3weeks, 2 cycles
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
102
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Gyeonggi-do
-
Goyang-si, Gyeonggi-do, Korea, Republikken, 411-769
- Rekruttering
- National Cancer Center, Korea
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Underforsker:
- Jae-Ill Zoo, M.D.
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Underforsker:
- Jong Mog Lee, M.D.
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Underforsker:
- Moon Soo Kim, M.D.
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Underforsker:
- Hyun-Sung Lee, M.D.
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Underforsker:
- Jin Soo Lee, M.D.
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Underforsker:
- Hyae Young Kim, M.D.
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Underforsker:
- Moon Woo Seong, M.D.
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Underforsker:
- Kyeong-Man Hong, M.D.
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-
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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Histologic or cytologic diagnosis of non-small cell lung cancer.
- Presence of biopsy-proven N2 stage IIIA, according to the American Joint Committee on Cancer (AJCC), with none of the mediastinal lymph nodes > 3 cm in largest diameter.
- Tumor amenable to surgical resection.
- At least one unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST. 2000).
- No prior tumor therapy (surgery, radiotherapy, chemotherapy, immunotherapy, or any other type of tumor therapy).
- Performance status of 0-1 on ECOG scale.
- At least 18 years old.
- Patient compliance that allows adequate follow-up.
- Medical fitness of patients adequate for radical NSCLC surgery.
- Adequate organ function including the following:Adequate hematologic function: WBC count ≥ 4,000/uL, absolute neutrophil count (ANC) ≥ 1,500/uL, platelet count ≥ 100,000/uL, and hemoglobin ≥ 10 gm/dL.Adequate hepatic function: bilirubin ≤ 1.5 x UNL, ALT or AST ≤ 2.5 x UNL.Adequate renal function: creatinine ≤ 1.5mg/dL.
- Signed informed consent from patient or legal representative.12. Patients with reproductive potential must use an approved contraceptive method during and for 3 months after the study. Females with childbearing potential must have a negative urine hCG test within 7 days prior to study enrollment.
Exclusion Criteria:
- Concurrent administration of any other tumor therapy, including radiotherapy, chemotherapy, immunotherapy.
- Active uncontrolled infection.
- Serious concomitant disorders that would compromise the safety of patient or compromise the patient's ability to tolerate therapy.
- MI within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia.
- Significant neurological or mental disorder.
- Second primary malignancy.
- Pregnant or nursing.
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 |
|---|---|
|
Aktiv komparator: study arm
pre-operative chemotherapy (Pac/Cis)
|
Paclitaxel 90mg/m2 + Cisplatin 40mg/m2 on D1 & 8 q 3weeks, Pre-OP & post-op : 2cycles (total 4 cycles)
|
|
Aktiv komparator: study arm 2
Pre-operative concurrent chemoradiation therapy
|
Paclitaxel 50mg/m2 + Cisplatin 20mg/m2 on D1 & 8 q 3weeks, Pre-OP & post-op : 2cycles (total 4 cycles)
Preoperative Thoracic radiation: 180cGy/fx, total: 4500cGy, 25fx
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
To estimate the time to recurrence
Tidsramme: The interval from the date of randomization to the date to the date of the first objective evidence of recurrence or to the date of death, if before recurrence
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The interval from the date of randomization to the date to the date of the first objective evidence of recurrence or to the date of death, if before recurrence
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
To estimate the overall survival
Tidsramme: from the date of randomization to the date of death
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from the date of randomization to the date of death
|
|
To assess the pathologic complete response rate and the complete resection rate
Tidsramme: After surgery
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After surgery
|
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To estimate toxicities
Tidsramme: from the first date of treatment to 30 days after the last dose of study drug
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from the first date of treatment to 30 days after the last dose of study drug
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Heung Tae Kim, M.D., National Cancer Center, Korea
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
1. april 2006
Primær færdiggørelse (Forventet)
1. december 2011
Studieafslutning (Forventet)
1. december 2012
Datoer for studieregistrering
Først indsendt
27. marts 2007
Først indsendt, der opfyldte QC-kriterier
27. marts 2007
Først opslået (Skøn)
28. marts 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
12. juli 2010
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. juli 2010
Sidst verificeret
1. juli 2010
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NCCCTS-06-164
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