Palliative Radiotherapy for Symptomatic Locally Advanced Gastric Cancer: A Phase II Trial

Palliative Radiotherapy for Symptomatic Locally Advanced Gastric Cancer: A Phase II Trial

Sponsoren

Hauptsponsor: National University Hospital, Singapore

Mitarbeiter: Tan Tock Seng Hospital

Quelle National University Hospital, Singapore
Kurze Zusammenfassung

The hypothesis of this study is that a radiotherapy dose of 36Gy in 12 fractions, which equates to a BED of 48.6Gy, increases the response rates of symptom relief compared to historical controls.

detaillierte Beschreibung

The hypothesis of this study is that a radiotherapy dose of 36Gy in 12 fractions, which equates to a BED of 48.6Gy, increases the response rates of symptom relief compared to historical controls. (Tey et al.) With this dose fractionation is used for bleeding, there is an increase in response rates from 55%(historical) to 75%for pain, there is an increase in response rates from 25% (historical) to 45% for obstruction, there is an increase in response rates from 25% (historical) to 45%

Gesamtstatus Unknown status
Anfangsdatum July 2009
Fertigstellungstermin July 2012
Primäres Abschlussdatum July 2011
Phase Phase 2
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Response of bleeding to radiotherapy At the 12th fraction of radiotherapy and at one month post radiotherapy
Sekundäres Ergebnis
Messen Zeitfenster
Number of patients who develop anorexia, nausea, vomiting as per common toxicity criteria v3.0 within the first 14 days from start of radiotherapy
Einschreibung 63
Bedingung
Intervention

Interventionsart: Radiation

Interventionsname: Palliative Radiotherapy

Beschreibung: Palliative Radiotherapy to a total dose of 36Gy in 12 fractions

Armgruppenetikett: Radiotherapy for gastric cancer

Anderer Name: palliation, radiotherapy

Teilnahmeberechtigung

Kriterien:

Inclusion Criteria:

- Biopsy proven adenocarcinoma of the stomach

- Treated with palliative intent

- At least one index symptom such as bleeding, obstruction or pain

- No prior abdominal radiotherapy

- Not on chemotherapy

Exclusion Criteria:

- Patients treated with radical intent

- Previous abdominal radiotherapy

- Patients on chemotherapy

Geschlecht: All

Mindestalter: 21 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Jeremy Tey, FRANZCR Principal Investigator National University Hospital, Singapore
Gesamtkontakt

Nachname: Jeremy Tey, FRANZCR

Telefon: +65 67724869

Email: [email protected]

Ort
Einrichtung: Status: Kontakt: Ermittler: National University Hospital Jeremy Tey, FRANZCR +65 67724869 [email protected] Jeremy Tey, FRANZCR Principal Investigator
Standort Länder

Singapore

Überprüfungsdatum

April 2011

Verantwortliche Partei

Nenne den Titel: Jeremy Tey

Organisation: National University Hospital

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 1
Armgruppe

Etikette: Radiotherapy for gastric cancer

Art: Experimental

Beschreibung: Single arm study

Studiendesign Info

Zuweisung: Non-Randomized

Interventionsmodell: Single Group Assignment

Hauptzweck: Treatment

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov