Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer That Has Been Completely Removed By Surgery - Full Text View

Sponsored by:	Federation Nationale des Centres de Lutte Contre le Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00410683

Purpose

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving radiation therapy after surgery is more effective than no radiation therapy in treating patients with non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to no radiation therapy in treating patients with non-small cell lung cancer that has been completely removed by surgery.

Condition	Intervention	Phase
Lung Cancer	Procedure: adjuvant therapy Procedure: observation Radiation: 3-dimensional conformal radiation therapy	Phase III

MedlinePlus related topics: Cancer Lung Cancer Radiation Therapy Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized
Official Title:	Phase III Study Comparing Post-Operative Conformal Radiotherapy to No Post-Operative Radiotherapy in Patients With Completely Resected Non-Small Cell Lung Cancer and Mediastinal N2 Involvement [Lung ART]

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

Primary Outcome Measures:

Disease-free survival (DFS) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Acute and late toxicity (with identification of predictive factors of toxicity) [ Designated as safety issue: Yes ]
Local control [ Designated as safety issue: No ]
Patterns of recurrence [ Designated as safety issue: No ]
Overall survival (OS) [ Designated as safety issue: No ]
Second cancers [ Designated as safety issue: No ]
Prognostic and predictive factors of treatment effect on DFS and OS [ Designated as safety issue: No ]
Cost per recurrence-free year of life [ Designated as safety issue: No ]

Estimated Enrollment:	700
Study Start Date:	February 2007
Estimated Primary Completion Date:	February 2021 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Compare the disease-free survival of patients with completely resected non-small cell lung cancer treated with conformal thoracic radiotherapy vs no radiotherapy.

Secondary

Determine the toxicity, in particular cardiac and pulmonary toxicity, of these regimens in these patients.
Compare the local control in patients treated with these regimens.
Determine patterns of recurrence in patients treated with these regimens.
Determine the overall survival of patients treated with these regimens.
Assess second cancers in patients treated with these regimens.
Assess prognostic factors and predictive factors of treatment effect on disease-free survival and overall survival of patients treated with these regimens.
Determine the cost per recurrence-free year of life.

OUTLINE: This is a multicenter, randomized study.

Patients are stratified according to participating center, prior chemotherapy (neoadjuvant alone vs adjuvant vs none), number of lymph nodes involved (0 vs 1 vs ≥ 2), histology (squamous cell vs other), and use of pretreatment positron emission tomography scans (yes vs no). Patients are randomized to 1 of 2 treatment arms.

Arm I: Beginning within 4-8 weeks after surgery or 2-4 weeks after chemotherapy, patients undergo adjuvant thoracic conformal radiotherapy once daily, 5 days per week, for 6 weeks.
Arm II: Patients do not undergo adjuvant thoracic radiotherapy. After completion of study therapy, patients are followed periodically for up to10 years.

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed non-small cell lung cancer
- N2 mediastinal nodal involvement prior to neoadjuvant chemotherapy OR at the time of surgery in the absence of neoadjuvant chemotherapy
Completely resected disease by lobectomy, bilobectomy, or pneumonectomy (absence of positive margins or extracapsular extension in a node removed separately)
- Has undergone mediastinal lymph node exploration (lymph node sampling or complete dissection of lymph nodes at levels 4, 7, and 10 in case of right-sided thoracotomy and at levels 4 [if accessible], 5, 6, 7, and 10 in case of left-sided thoracotomy)
No documented metastases
No major pleural or pericardial effusion
No synchronous contralateral lung cancer
No clinical progression during post-operative chemotherapy

PATIENT CHARACTERISTICS:

Not pregnant or nursing
Fertile patients must use effective contraception
WHO performance status 0-1
Post-operative FEV_1 > 1 L (or > 35% theoretical value, PO_2 ≥ 70 mm Hg, and PCO_2 < 45 mm Hg)
No severe cardiac disease within the past 6 months, including the following:
- Arrhythmia
- Congestive heart failure
- Infarction
- Pacemaker
No severe pulmonary disease within the past 6 months
No weight loss ≥ 10% within the 6 months before surgery
No other prior or concurrent neoplasm, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix
No severe or uncontrolled systemic disease
No familial, social, geographic, or psychological conditions that would preclude study participation

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Prior chemotherapy allowed (neoadjuvant and/or adjuvant chemotherapy)
No prior chest radiotherapy
No concurrent chemotherapy during radiotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410683

Locations

France
Centre Alexis Vautrin	Recruiting
Vandoeuvre-les-Nancy, France, 54511
Contact: Veronique Beckendorf 33-3-8359-8425
Centre Antoine Lacassagne	Recruiting
Nice, France, 06189
Contact: Pierre-Yves Bondiau, MD, PhD 33-4-9203-1261
Centre de Lutte Contre le Cancer Georges-Francois Leclerc	Recruiting
Dijon, France, 21079
Contact: Karine Peignaux, MD 33-380-737-518
Centre Eugene Marquis	Recruiting
Rennes, France, 35042
Contact: Mohamed Benchalal, MD 33-2-9925-3000 m.benchalal@rennes.fnclcc.fr
Centre Jean Perrin	Recruiting
Clermont-Ferrand, France, 63011
Contact: Pierre-Yves Verrelle 33-4-7327-8375 pierre.verrelle@cjp.fr
Centre Paul Papin	Recruiting
Angers, France, 49036
Contact: Claude Tuchais, MD 02-41-35-2884 c.tuchais@unimedan.fr
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Recruiting
Montpellier, France, 34298
Contact: Antoine Serre, MD 33-142-114-757
Centre Regional Francois Baclesse	Recruiting
Caen, France, 14076
Contact: Delphine Lerouge, MD 33-2-3145-5020 d.lerouge@baclesse.fr
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes	Recruiting
Marseille, France, 13273
Contact: Naji Salem, MD 33-4-9122-3637
Hopital Avicenne	Recruiting
Bobigny, France, 93009
Contact: Jean F. Morere, MD 33-1-48-955-032
Hopital Europeen Georges Pompidou	Recruiting
Paris, France, 75015
Contact: Catherine Maulard-Durdux, MD 33-1-56-09-3402
Hopital Tenon	Recruiting
Paris, France, 75970
Contact: Armelle Lavole, MD 33-156-016-204
Hopitaux de Brabois	Recruiting
Vandoeuvre-Les-Nancy, France, 54511
Contact: Yves Martinet, MD, PhD 33-3-83-15-34-80 y.martinet@chu-nancy.fr
Institut Curie Hopital	Recruiting
Paris, France, 75248
Contact: Philippe Giraud, MD 33-144-324-625
Institut Gustave Roussy	Recruiting
Villejuif, France, F-94805
Contact: Cecile Le Pechoux, MD 33-1-42-114-757
Institut Sainte Catherine	Recruiting
Avignon, France, 84000
Contact: Nicolas Pourel, MD 33-490-27-60-31
CHU de Caen	Recruiting
Caen, France, 14033
Contact: Gerard Zalcman, MD, PhD 33-231-06-46-77

Sponsors and Collaborators

Federation Nationale des Centres de Lutte Contre le Cancer

Investigators

Study Chair:

Cecile Le Pechoux, MD

Institut Gustave Roussy

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000523568, FRE-FNCLCC-PROTEGE-01/0601, EU-20671, IFCT-05-03, PAC POUMON
Study First Received:	December 11, 2006
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00410683 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Adjuvants, Immunologic

Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on May 06, 2009