Non-small-cell Lung Cancer Clinical Trial
Official title:
Phase IV Study of Concurrent Chemoradiotherapy With Paclitaxel and Cisplatin in Previously Untreated, Inoperable (Stage IIIa or IIIb) Non-small-cell Lung Cancer
Present study is to investigate efficacy and toxicity profiles of induction one cycle of paclitaxel plus cisplatin (PC), concurrent 2 cycles of PC with radiotherapy, followed by 2 cycles of PC consolidation chemotherapy.
Lung cancer is a major cause of cancer death in Taiwan and throughout the world in both
developed and developing countries. More than 75% of NSCLC patients are inoperable because
of either distantly metastatic disease or disease confined to one hemithorax with one or
more criteria of unresectability at the time of presentation. The prognosis of such
inoperable metastatic patients is poor.
The benefit of adding chemotherapy to radiation therapy for stage III disease of NSCLC is
well-established. The largest of the prospective trials was sponsored by the Radiation
Therapy Oncology Group (RTOG), ECOG, and the Southwest Oncology Group (SWOG), and allocated
490 patients to receive 2 months of cisplatin + vinblastine chemotherapy followed by 60 Gy
of radiation at 2 Gy per fraction; or one of two radiation-alone arms. Overall survival was
statistically superior for the patients receiving chemotherapy and radiation versus the
other two arms of the study (13.2 months vs 12 months, vs 11.4 months, respectively;
p=0.04).
Administration of chemotherapy concurrently with radiation therapy theoretically improves
local control by sensitizing the tumor to radiation, while simultaneously treating systemic
disease, albeit at the expense of greater local toxicity. Two large phase III studies
suggest improvement in both local control and survival with concurrent chemoradiotherapy as
compared with sequential chemotherapy followed by radiation for patients with stage III
NSCLC. Although rates of nonhematologic toxicity were higher on the concurrent arms, median
survival time trended toward superiority in the concomitant chemotherapy plus daily
radiation arm compared with the sequential arm.
One source of debate is whether the addition of induction or consolidation chemotherapy adds
anything to concomitant chemoradiotherapy, with numerous intergroup trials underway. CALGB
has completed a randomized phase II study of two cycles of induction chemotherapy followed
by two additional cycles of the same drugs with concomitant radiotherapy. The three
treatment arms included four cycles of cisplatin (80 mg/m2) combined with either
gemcitabine, paclitaxel, or vinorelbine. Radiotherapy was completed during the last two
cycles to a total of 66 Gy. Response rates were similar, and median survival for all
patients was 17 months with no clearly superior arm evident in this randomized phase II
trial.
We proposed this clinical trial to evaluate the efficacy and toxicity profile of combination
chemotherapy with paclitaxel and cisplatin in previously untreated, stage IIIa/IIIb NSCLC
patients who received 1 cycle of induction chemotherapy, followed by concurrent
chemoradiotherapy, with 2 cycles of consolidation chemotherapy.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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