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Non-small Cell Lung CancerPhase 3LUNG ARTNCT00410683

Radiation Therapy in Treating Patients With Non Small Cell Lung Cancer That Has Been Completely Removed by Surgery

A Phase 3 study testing clinical observation, adjuvant therapy and 3-dimensional conformal radiation therapy in people with Non-small Cell Lung Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
clinical observation, adjuvant therapy and 3-dimensional conformal radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteFrance
Study dates
Feb 2007to Feb 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological evidence of non-small cell lung cancer (NSCLC)
  • Complete resection by lobectomy, bilobectomy or pneumonectomy (i.e patients with positive margins) or extra-capsular mediastinal nodal extension breaching the surface of the pathological specimen should not to be included
  • Mediastinal lymph node exploration (lymph node sampling or systematic dissection of lymph nodes at stations 2, 4 and 7 in case of upper/middle right-sided lung cancer; 4, 7, 8 and 9 in case of lower right-sided lung cancer; 5, 6 and 7 in case of upper left -sided lung cancer; 7, 8 and 9 in case of lower left-sided lung cancer is recommended)
  • Pathologically or cytologically documented N2 mediastinal nodal involvement, at the time of surgery if no preoperative chemotherapy or before preoperative chemotherapy, according to the criteria of the joint AJCC and UICC classification, clinical N2 patients without cytological or histological documentation of mediastinal node involvement before preoperative chemotherapy can be included in the study if and only if, they have histologically confirmed N2 disease at the time of surgery
  • Prior chemotherapy is allowed (pre-operative or post-operative adjuvant chemotherapy, or both)
  • Patient aged ≥ 18 years
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  • Good Performance status (WHO ≤ 2)
  • Fit enough to receive curative radiotherapy
  • Adequate pulmonary function with post-operative FEV1 after surgery > 1 l or over 35% theoretical value
  • Signed informed consent form

Who cannot join

  • Documented metastases, (except for ipsilateral nodule(s) in a different lobe after pneumonectomy or bi-lobectomy)
  • Major pleural or pericardial effusion
  • Synchronous contra-lateral lung cancer
  • Clinical progression during post-operative chemotherapy
  • Previous chest radiotherapy
  • Intention of concomitant chemotherapy during radiotherapy
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  • Weight loss in the previous 6 months before surgery ≥ 10 %
  • Evidence of severe or uncontrolled systemic disease as judged by the investigator
  • Recent (< 6 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction, pace-maker) or pulmonary disease
  • Current or past history of neoplasm other than non-small cell lung cancer diagnosed within the last 5 years, except :
  • basal cell carcinoma of the skin
  • in situ carcinoma of the cervix A patient diagnosed for another neoplasm 5 years ago or more, treated and considered as cured may be included in the study if all the other criteria are respected.
  • Pregnancy or breast feeding or inadequate contraceptive measures during treatment
  • Patients who, for family, social, geographic or psychological reasons, cannot be adequately followed up and/or are incapable of undergoing regular controls
  • Patient deprived of freedom or under guardianship

Trial locations and contacts

1 site in 1 country.

France1 site

  • Institut Gustave Roussy

    Villejuif, Val De Marne, 94805

Other trials in France

About this study

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]

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.

Read the 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 stations 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 2-6 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.

Being tested
clinical observation, adjuvant therapy, 3-dimensional conformal radiation therapy
Keywords
stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • clinical observationOther

  • adjuvant therapyProcedure or surgery

  • 3-dimensional conformal radiation therapyRadiation

Study groups in NCT00410683
Study groupRoleWhat they receive
RadiotherapyExperimentalBeginning within 4-8 weeks after surgery or 2-6 weeks after chemotherapy, patients undergo adjuvant thoracic conformal radiotherapy once daily, 5 days per week, for 6 weeks.
Receives: Other: clinical observation; Procedure: adjuvant therapy; Radiation: 3-dimensional conformal radiation therapy
No radiotherapyActive comparatorPatients do not undergo adjuvant thoracic radiotherapy. After completion of study therapy, patients are followed periodically for up to 10 years.
Receives: Other: clinical observation; Procedure: adjuvant therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free survival (DFS)

    Measured: assessed up every 3 and 6 months after randomization, every 6 months for the fist three years and yearly afterward

Secondary outcomes (7)

  1. Acute and late toxicity (with identification of predictive factors of toxicity)

    Measured: assessed up at 3 and 6 months after randomization and then yearly afterward; And in case of event

  2. Local control

    Measured: assessed up at 3 and 6 months after randomization and then yearly afterward; And in case of event

  3. Patterns of failure

    Measured: assessed up at 3 and 6 months after randomization and then yearly afterward; And in case of event

  4. Overall survival (OS)

    Measured: assessed up In case of death whatever the cause

  5. Second cancers

    Measured: Assessed up in case of event

  6. Prognostic and predictive factors of treatment effect on DFS and OS

    Measured: assessed up at the end of the study

  7. Cost per recurrence-free year of life

    Measured: Assessed up at the end of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2006 (estimated)
  2. Study startFeb 2007
  3. Primary completionJul 2018
  4. Study completionFeb 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00410683
Sponsor's protocol ID
CDR0000523568
Other IDs
2006/1202, PROTEGE-01/0601, 20671, IFCT - 0503, UK11/NW/0075
Acronym
LUNG ART
Status last verified
Nov 2020
First submitted
11 Dec 2006
Last updated
20 Nov 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Predina J, Suliman R, Potter AL, Panda N, Diao K, Lanuti M, Muniappan A, Jeffrey Yang CF. Postoperative radiotherapy with modern techniques does not improve survival for operable stage IIIA-N2 non-small cell lung cancer. J Thorac Cardiovasc Surg. 2023 May;165(5):1696-1709.e4. doi: 10.1016/j.jtcvs.2022.09.062. Epub 2022 Oct 18.

    PubMed 36610886

  • Le Pechoux C, Pourel N, Barlesi F, Lerouge D, Antoni D, Lamezec B, Nestle U, Boisselier P, Dansin E, Paumier A, Peignaux K, Thillays F, Zalcman G, Madelaine J, Pichon E, Larrouy A, Lavole A, Argo-Leignel D, Derollez M, Faivre-Finn C, Hatton MQ, Riesterer O, Bouvier-Morel E, Dunant A, Edwards JG, Thomas PA, Mercier O, Bardet A. Postoperative radiotherapy versus no postoperative radiotherapy in patients with completely resected non-small-cell lung cancer and proven mediastinal N2 involvement (Lung ART): an open-label, randomised, phase 3 trial. Lancet Oncol. 2022 Jan;23(1):104-114. doi: 10.1016/S1470-2045(21)00606-9. Epub 2021 Dec 15.

    PubMed 34919827

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing clinical observation, adjuvant therapy and 3-dimensional conformal radiation therapy in people with Non-small Cell Lung Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival (DFS) (time frame: assessed up every 3 and 6 months after randomization, every 6 months for the fist three years and yearly afterward). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00410683, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020; AzTrials last refreshed its copy on 26 Oct 2026.

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