Radiation Therapy in Patients With Limited-Stage Small Cell Lung Cancer in Complete Remission - Full Text View

Sponsor:	Institut Gustave Roussy
Collaborator:	European Organization for Research and Treatment of Cancer - EORTC
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00005062

Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and prevent the spread of cancer to the brain. It is not yet known if standard-dose radiation therapy is more effective than high-dose radiation therapy in preventing the spread of limited-stage small cell lung cancer cells to the brain.

PURPOSE: This randomized phase III trial is comparing two different regimens of radiation therapy to see how well they work in treating patients with limited-stage small cell lung cancer in complete remission.

Condition	Intervention	Phase
Lung Cancer	Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
Official Title:	A Phase III Trial Comparing High Versus Standard Dose of Prophylactic Cranial Irradiation (PCI) in Limited Small Cell Lung Cancer Complete Responders

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Incidence of brain metastases 2 years after randomization [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival and disease-free survival 2 years after randomization [ Designated as safety issue: No ]
Quality of life as assessed by Quality of Life Questionnaire (QLQ)-C30/BN20 before randomization, at 6 and 12 months, and annually thereafter [ Designated as safety issue: No ]
Treatment late sequelae as assessed by Late Effect of Normal Tissue - Subjective Objective Management Analytic scale, brain CT scan, or MRI before randomization and then annually thereafter [ Designated as safety issue: No ]

Study Start Date:

September 1999

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	up to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005062

Show 93 Study Locations

Sponsors and Collaborators

Institut Gustave Roussy

European Organization for Research and Treatment of Cancer - EORTC

Investigators

Investigator:	Cecile Le Pechoux, MD	Institut Gustave Roussy
Investigator:	Suresh Senan	Free University Medical Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Le Péchoux C, Laplanche A, Faivre-Finn C, Ciuleanu T, Wanders R, Lerouge D, Keus R, Hatton M, Videtic GM, Senan S, Wolfson A, Jones R, Arriagada R, Quoix E, Dunant A; on behalf of the Prophylactic Cranial Irradiation (PCI) Collaborative Group. Clinical neurological outcome and quality of life among patients with limited small-cell cancer treated with two different doses of prophylactic cranial irradiation in the intergroup phase III trial (PCI99-01, EORTC 22003-08004, RTOG 0212 and IFCT 99-01). Ann Oncol. 2010 Dec 7; [Epub ahead of print]

Le Péchoux C, Dunant A, Senan S, Wolfson A, Quoix E, Faivre-Finn C, Ciuleanu T, Arriagada R, Jones R, Wanders R, Lerouge D, Laplanche A; on behalf of the Prophylactic Cranial Irradiation (PCI) Collaborative Group. Standard-dose versus higher-dose prophylactic cranial irradiation (PCI) in patients with limited-stage small-cell lung cancer in complete remission after chemotherapy and thoracic radiotherapy (PCI 99-01, EORTC 22003-08004, RTOG 0212, and IFCT 99-01): a randomised clinical trial. Lancet Oncol. 2009 Apr 20; [Epub ahead of print]

Pechoux CL, Hatton M, Kobierska A, et al.: Randomized trial of standard dose to a higher dose prophylactic cranial irradiation (PCI) in limited-stage small cell cancer (SCLC) complete responders (CR): primary endpoint analysis (PCI99-01, IFCT 99-01, EORTC 22003-08004, RTOG 0212). [Abstract] J Clin Oncol 26 (Suppl 15): A-LBA7514, 2008.

ClinicalTrials.gov Identifier:	NCT00005062 History of Changes
Other Study ID Numbers:	CDR0000067664, FRE-IGR-PCI-99, EU-99051, FRE-IFCT-99.01, FRE-IGR-PCI99-EULINT1, EORTC-22003, EORTC-08004
Study First Received:	April 6, 2000
Last Updated:	January 15, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

limited stage small cell lung cancer

Additional relevant MeSH terms:

Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site

Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on February 09, 2012