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Phase IV Study of Concurrent Chemoradiotherapy With Paclitaxel and Cisplatin in Previously Untreated, Inoperable (Stage IIIa or IIIb) Non-small-cell Lung Cancer


Phase 4
18 Years
N/A
Not Enrolling
Both
Non-small-cell Lung Cancer

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Trial Information

Phase IV Study of Concurrent Chemoradiotherapy With Paclitaxel and Cisplatin in Previously Untreated, Inoperable (Stage IIIa or IIIb) Non-small-cell Lung Cancer


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.


Inclusion Criteria:



- Histologic or cytological diagnosis of inoperable locally advanced (stage III) NSCLC.

- No prior chemotherapy, immunotherapy, or radiotherapy.

- Performance status of 0 to 2 on the Zubrod scale.

- Clinically measurable disease, defined as bidimensionally measurable lesions with
clearly defined margins on x-ray, scan, or physical examination. Lesions serving as
measurable disease must be at least 1 cm by 1 cm, as defined by computerized
tomography (CT) scan, magnetic resonance imaging (MRI), or chest x-ray.

- Estimated life expectancy of at least 12 weeks.

- Patient compliance and geographic proximity that allow adequate follow-up.

- Adequate bone marrow reserve: white blood cell (WBC) count *4,000/mm3, platelets
>100,000/mm3, and hemoglobin *10 g/dL.

- Informed consent from patient.

- Males or females 18 years of age or older.

- If female: childbearing potential either terminated by surgery, radiation, or
menopause, or attenuated by use of an approved contraceptive method (intrauterine
contraceptive device [IUD], birth control pills, or barrier device) during and for
three months after trial.

Exclusion Criteria:

- Active infection (at the discretion of the investigator).

- Inadequate liver function (total bilirubin >1.5 times above normal range); alanine
transaminase (ALT) and aspartate transaminase (AST) greater than 3 times normal (ALT
and AST may be elevated to 5 times normal in patients with known metastatic disease
in the liver).

- Inadequate renal function (creatinine >2.0 mg/dL).

- Pregnancy or not using appropriate birth control during the study.

- Breast feeding.

- Serious concomitant systemic disorders incompatible with the study (at the discretion
of the investigator).

- Second primary malignancy (except in situ carcinoma of the cervix or adequately
treated basal cell carcinoma of the skin)

- Use of any investigational agent in the month before enrollment into the study.

- Patients with leukemia and/or a secondary primary carcinoma except for patients who
have had curative therapy to basal cell carcinoma.

- Concomitant myelosuppressive radiotherapy, chemotherapy, hormonal therapy, or
immunotherapy will not be allowed except as previously noted for radiation.

- Active cardiac disease requiring therapy for failure, angina, and/or arrhythmias;
infarctions within the preceding six months (exception: any patient whose cardiac
failure is compensated on medications).

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the efficacy of this treatment modality in patients with inoperable stage III NSCLC

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

Yuh-Min Chen, MD, PhD.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chest Department, Taipei VGH

Authority:

Taiwan: Department of Health

Study ID:

97-02-12

NCT ID:

NCT00686322

Start Date:

April 2008

Completion Date:

October 2009

Related Keywords:

  • Non-Small-Cell Lung Cancer
  • chemotherapy
  • radiotherapy
  • lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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