Induction Chemotherapy Followed by CCRT According to EGFR Mutation Status in NSCLC III

Sponsor
National Cancer Center, Korea
Study ID
NCT00620269
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
    Erlotinib 150 mg p.o. daily x21 days every 3 weeks
  • Induction or consolidation IP chemotherapy — DRUG
    Irinotecan 65mg/m2 + Cisplatin 30mg/m2 IV on D1,D8 every 3 weeks X 3 cycles
  • CCRT with IP chemotherapy (Irinotecan + Cisplatin) — DRUG
    Irinotecan (60mg/m2) + cisplatin (30mg/m2) IV on D1 \& 8 every 3 weeks X 2 cycles
  • CCRT — RADIATION
    CCRT :Concurrent Thoracic Radiotherapy (2.4 Gy/fr, Total 60 Gy, 25fr over 5 weeks)

Study Details

The use of induction chemotherapy is feasible and effective. It is also logistically beneficial for decreasing micrometastases and radiation-related toxicity by decreasing tumor burden before definite locoregional concurrent therapy. Previously the investigators conducted several phase II study of IP chemotherapy in advanced NSCLC and demonstrated that IP chemotherapy has a promising activity and readily manageable toxicity profile. Given the encouraging activity of IP chemotherapy in the advanced stage setting, the investigators postulated that their further investigation in the stage III setting might lead to further prolongation of survival times. In addition to cisplatin, Irinotecan has been demonstrated to act as radiation sensitizers in preclinical and clinical setting. Therefore, their use with concurrent radiotherapy might lead to radiation sensitization and improved locoregional control.

Key Dates

Start date
Feb 29, 2008
Status verified
Nov 2011
Primary completion
Mar 31, 2015
Completion
Mar 31, 2015

Study Design

Enrollment
212 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: study arm 1
    Induction (with Erlotinib X 3 cycles) -\> CCRT with Erlotinib (X 2 cycles) -\> continue Erlotinib (X 6 cycles)
  • Experimental: study arm 3
    Induction (IP X 3 cycles) -\> CCRT with IP (X 2 cycles)
  • Active Comparator: control arm
    CCRT with IP (X 2 cycles) -\> consolidation IP (X 3 cycles)
  • Experimental: study arm 2
    Induction (Erlotinib X 3 cycles) -\> CCRT with IP (X 2 cycles) -\> recurrence -\> Erlotinib (until PD)

Primary Outcome Measure

Response rate [ Time Frame: every 8 weeks ]

Central Contacts

Related Studies