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.

Phase 3

Completed

• Conditions: 10029107; non small cell lung cancer; lung cancer; 10038666

• Registration Number: NL-OMON33550
• Lead Sponsor: MAASTRO clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 195

Inclusion Criteria

1) Histological evidence of non-small cell lung cancer (NSCLC)
2) Complete resection with mediastinal lymph node exploration
3) Pathologically or cytologically documented 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,
4) No past history of chest radiotherapy
5) Prior chemotherapy is allowed
6) Patient aged >18 years
7) WHO 0 or 1
8) Adequate pulmonary function
9) No severe cardiac or pulmonary disease,
10) Possibility of long-term follow-up
11) Information given to patient and signed informed consent form.

Exclusion Criteria

1) Documented metastases,
2) Pleural or pericardial effusion,
3) Synchronous contra-lateral lung cancer,
4) Clinical progression during post-operative chemotherapy,
5) Incomplete resection
6) Lack of mediastinal lymph node exploration,
7) Previous chest radiotherapy
8) Intention of concomitant chemotherapy during radiotherapy
9) Weight loss before surgery more than 10%
10) Evidence of severe or uncontrolled systemic disease as judged by the investigator
11) Recent ( < 6 months) severe cardiac disease
12) Past or current history of neoplasm other than non-small cell lung cancer
13) Pregnancy or breast feeding or absence of adequate contraceptive measures during treatment
14) Patients who cannot be adequately followed up
15) Patient deprived of freedom or under guardianship.

Study & Design

• Study Type: Interventional
• Study Design: Not specified