Hypofractionated Intensity Modulated Chemoradiotherapy to Treat Locally Advanced Non-Small Cell Lung Cancer

Phase II Study on Dose Escalated, Accelerated Hypofractionated Intensity Modulated Radiotherapy for Stage III Non-Small Cell Lung Cancer With Concurrent Chemotherapy

Sponsoren

Hauptsponsor: National University Hospital, Singapore

Mitarbeiter: Tan Tock Seng Hospital

Quelle National University Hospital, Singapore
Kurze Zusammenfassung

Locally advanced non-small cell lung cancer can be treated successfully with chemotherapy and radiation. However, the cure rate is low.

This study is carried out to find out whether giving radiotherapy at a higher dose over fewer treatment sessions with intensity modulated radiotherapy (IMRT) can improve the treatment outcome.

This study aims to recruit 43 patients from National University Hospital and Tan Tock Seng Hospital over a period of about 2 years.

Gesamtstatus Unknown status
Anfangsdatum July 2009
Primäres Abschlussdatum July 2011
Phase Phase 2
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Overall survival 2 years
Sekundäres Ergebnis
Messen Zeitfenster
Response rate, locoregional control, disease free survival, toxicity 2 years
Einschreibung 43
Bedingung
Intervention

Interventionsart: Radiation

Interventionsname: Dose escalated, accelerated, hypofractionated radiotherapy

Beschreibung: Intensity modulated radiotherapy with concurrent chemotherapy

Teilnahmeberechtigung

Kriterien:

Inclusion Criteria:

- Pathologically proven (either histologic or cytologic) diagnosis of Stage IIIA or IIIB non-small cell lung cancer; excluding patients with N3 disease based on supraclavicular or contralateral hilar adenopathy, or significant pleural / pericardial effusion.

Exclusion Criteria:

- Patients for whom treatment is planned with a maximum dose of ≥ 66 Gy to the ipsilateral brachial plexus

- Greater than minimal, exudative, or cytologically positive pleural effusions

- ≥ 10% weight loss within the past month

- Prior invasive malignancy (with exceptions)

- Prior radiotherapy to the region of the study cancer

- Significant co-morbidities

- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception

- Known allergic reactions to components of planned chemotherapy regimen

Geschlecht: All

Mindestalter: 21 Years

Maximales Alter: 70 Years

Gesunde Freiwillige: No

Gesamtkontakt

Nachname: Ivan Tham, MD

Telefon: 6567724870

Email: [email protected]

Ort
Einrichtung: Status:
National University Hospital | Singapore, Singapore Recruiting
National University Hospital | Singapore, Singapore Recruiting Jay Lu, MD 6567724870
Tan Tock Seng Hospital | Singapore, Singapore Recruiting Cheng Nang Leong, MD 6563571070 Cheng Nang Leong, MD Principal Investigator
Standort Länder

Singapore

Überprüfungsdatum

July 2009

Verantwortliche Partei

Nenne den Titel: Dr Ivan Tham

Organisation: National University Health System

Hat den Zugriff erweitert No
Bedingung Durchsuchen
Studiendesign Info

Zuweisung: N/A

Interventionsmodell: Single Group Assignment

Hauptzweck: Treatment

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov