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A Phase III Trial Comparing High Versus Standard Dose of Prophylactic Cranial Irradiation (PCI) in Limited Small Cell Lung Cancer Complete Responders


Phase 3
N/A
70 Years
Open (Enrolling)
Both
Lung Cancer

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Trial Information

A Phase III Trial Comparing High Versus Standard Dose of Prophylactic Cranial Irradiation (PCI) in Limited Small Cell Lung Cancer Complete Responders


OBJECTIVES:

- Compare high-dose versus standard-dose prophylactic cranial radiotherapy in terms of
the incidence of brain metastases and overall and disease free survival at 2 years in
patients with limited stage small cell lung cancer in complete remission.

- Evaluate the quality of life and late sequelae in this patient population treated with
these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, age (60 and under vs over 60), and interval between the start of
induction therapy and date of randomization (90 days or less vs 91-180 days vs more than 180
days). Patients are randomized into one of two treatment arms according to the prophylactic
cranial radiotherapy dose.

- Arm I: Patients receive standard-dose prophylactic cranial radiotherapy (10
fractions/12 days).

- Arm II: Patients receive high-dose prophylactic cranial radiotherapy administered over
16 or 24 days based on the choice of their treatment center.

- 18 fractions/24 days (conventional radiotherapy) OR

- 24 fractions/16 days (accelerated hyperfractionated radiotherapy) Patients with
isolated brain failure may undergo further radiotherapy.

Quality of life is assessed prior to randomization, at 6 months, at 1 year, and then
annually thereafter.

Patients are followed at least every 6 months for 2 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 700 patients will be accrued for this study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven limited stage small cell lung cancer

- Complete response to induction therapy (at least on chest x-ray)

- Normal brain CT scan or MRI less than 1 month prior to study

- No metastases (including ipsilateral lung metastases and malignant pleural effusion)

PATIENT CHARACTERISTICS:

Age:

- 70 and under

Performance status:

- WHO 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Cardiovascular:

- No prior cerebrovascular disease

Other:

- No epilepsy requiring permanent oral medication

- No other prior malignancy except skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

- No concurrent chemotherapy

Endocrine therapy:

- Concurrent steroids allowed

Radiotherapy:

- Concurrent thoracic radiotherapy allowed

Surgery:

- Not specified

Other

- No other concurrent antitumoral agent

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Incidence of brain metastases 2 years after randomization

Safety Issue:

No

Principal Investigator

Cecile Le Pechoux, MD

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

United States: Federal Government

Study ID:

CDR0000067664

NCT ID:

NCT00005062

Start Date:

September 1999

Completion Date:

Related Keywords:

  • Lung Cancer
  • limited stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030