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

NCT00410683 | Unknown Phase 3 DMC

• 6 other identifiers: CDR00005235682006/1202PROTEGE-01/060120671IFCT - 0503UK11/NW/0075
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Non-small Cell Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS)

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

Secondary Outcomes (7)

• Acute and late toxicity (with identification of predictive factors of toxicity)

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

• Local control

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

• Patterns of failure

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

• Overall survival (OS)

  assessed up In case of death whatever the cause

• Second cancers

  Assessed up in case of event

Study Arms (2)

Radiotherapy

EXPERIMENTAL

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.

Other: clinical observation; Procedure: adjuvant therapy; Radiation: 3-dimensional conformal radiation therapy

No radiotherapy

ACTIVE COMPARATOR

Patients do not undergo adjuvant thoracic radiotherapy. After completion of study therapy, patients are followed periodically for up to 10 years.

Other: clinical observation; Procedure: adjuvant therapy

Interventions

clinical observation OTHER

No radiotherapy; Radiotherapy

adjuvant therapy PROCEDURE

No radiotherapy; Radiotherapy

3-dimensional conformal radiation therapy RADIATION

Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead
• Intergroupe Francophone de Cancerologie Thoracique: collaborator
• The Christie NHS Foundation Trust: collaborator
• European Organisation for Research and Treatment of Cancer - EORTC: collaborator

Study Sites (1)

Institut Gustave Roussy

Villejuif, Val De Marne, 94805, France

Location

Related Publications (2)

• 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.

  PMID: 36610886 DERIVED

• 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.

  PMID: 34919827 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Watchful Waiting; Chemotherapy, Adjuvant; Radiotherapy, Conformal

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy, Computer-Assisted; Radiotherapy

Study Officials

• Cecile Le Pechoux, MD

  Gustave Roussy, Cancer Campus, Grand Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2006
• First Posted: December 13, 2006
• Study Start: February 1, 2007
• Primary Completion: July 1, 2018
• Study Completion: February 1, 2022
• Last Updated: November 20, 2020

Record last verified: 2020-11

Locations

FR (1)