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Phase I/II Study Of Concurrent Chemotherapy And Escalating Doses Of Radiotherapy (RT) For Unresectable Non-Small Cell Lung Cancer (NSCLC) Using A New RT Paradigm

Phase 1/Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Phase I/II Study Of Concurrent Chemotherapy And Escalating Doses Of Radiotherapy (RT) For Unresectable Non-Small Cell Lung Cancer (NSCLC) Using A New RT Paradigm


- Determine the maximum tolerated dose of radiotherapy in combination with carboplatin
and paclitaxel in patients with unresectable non-small cell lung cancer.

- Determine the 2-year survival of patients treated with this regimen.

- Determine the progression-free local control rate in patients treated this regimen.

- Determine the tolerability of this regimen in these patients.

- Assess the quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of radiotherapy.

Patients undergo radiotherapy* once daily 5 days a week for 7 weeks and 2 days (a total of
37 fractions). Patients concurrently receive paclitaxel IV over 3 hours and carboplatin IV
over 30 minutes once weekly for 7 weeks. Treatment continutes in the absence of disease
progression or unacceptable toxicity.

NOTE: *No prophylactic nodal radiotherapy is administered

Cohorts of 3-6 patients receive escalating doses of radiotherapy until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2
of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 12
additional patients are treated at that dose level in the phase II portion of the study.

Beginning 3 weeks after completion of radiotherapy, patients receive paclitaxel and
carboplatin as above. Treatment repeats every 21 days for 3 courses in the absence of
disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, once during the last week of radiotherapy, and then
every 3 months for 2 years.

Patients are followed at 3 weeks, every 3 months for 21 months, and then every 6 months for
3 years.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.

Inclusion Criteria


- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

- Stage I, II, or III NSCLC that is unresectable due to tumor extent or other
medical reasons

- Measurable disease

- Tumor must not exceed volume that would require radiation volumes greater than those
allowed on this study

- No more than blunting of the costophrenic angle on chest x-ray due to pleural

- No more than small effusions seen on chest CT scan only

- No supraclavicular adenopathy



- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- At least 12 weeks


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Total bilirubin no greater than 1.5 times upper limit of normal (ULN) OR

- Direct bilirubin no greater than 1.5 times ULN

- AST no greater than 3 times ULN


- Creatinine clearance at least 40 mL/min


- No New York Heart Association class III or IV heart disease


- FEV_1 at least 1 L or 35% of predicted


- No grade 2 or greater peripheral neuropathy

- No weight loss of 10% or more within the past 3 months

- No uncontrolled infection

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, adequately treated noninvasive carcinoma (carcinoma in
situ), or localized prostate cancer

- No other severe underlying disease that would preclude study participation

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception



- No prior biologic therapy for NSCLC

- No concurrent biologic therapy

- No concurrent prophylactic filgrastim (G-CSF)


- No prior chemotherapy for NSCLC

- No other concurrent chemotherapy

Endocrine therapy:

- No prior endocrine therapy for NSCLC


- No prior radiotherapy for NSCLC


- No prior surgery for NSCLC

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD) as assessed by dose-limiting toxicity within 1 month after completion of study treatment (phase I)

Safety Issue:


Principal Investigator

Steven E. Schild, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

May 2002

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage I non-small cell lung cancer
  • stage II non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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