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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00310167
Other study ID # UCL/05/84
Secondary ID CRUK-FORTCRUK-BR
Status Completed
Phase Phase 3
First received March 29, 2006
Last updated November 16, 2017
Start date October 2005
Est. completion date January 2017

Study information

Verified date November 2017
Source University College, London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. It is not yet known which regimen of low-dose radiation therapy is more effective in treating follicular non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying two different regimens of low-dose radiation therapy (24Gy versus 4Gy) to compare how well they work in treating patients with follicular or marginal zone non-Hodgkin's lymphoma.


Description:

OBJECTIVES:

Primary

- Compare the local progression-free interval in patients with follicular non-Hodgkin's lymphoma (NHL) treated with 2 different regimens of low-dose radiotherapy.

Secondary

- Compare acute toxicity at 4 weeks in patients treated with these regimens.

- Compare late toxicity in patients treated with these regimens.

- Compare tumor response at 12 weeks in patients treated with these regimens.

- Compare overall survival in patients treated with these regimens.

- Assess the health economics of these regimens in these patients.

OUTLINE: This is a multicenter, randomized study. Patients are randomized to one of two treatment arms.

- Arm I 4Gy: Patients undergo low-dose radiotherapy once daily on days 1 and 2.

- Arm II 24Gy: Patients undergo low-dose radiotherapy once daily on days 1-5, 8-12, 15, and 16.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up for 5 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 650 patients will be accrued for this study.


Recruitment information / eligibility

Status Completed
Enrollment 614
Est. completion date January 2017
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility DISEASE CHARACTERISTICS:

- Histologically confirmed follicular or mmarginal zone non-Hodgkin's lymphoma (NHL)

- Any stage

- Radiotherapy is indicated for curative treatment of stage IA or IIA disease OR palliation due to tumor bulk or anatomical position

PATIENT CHARACTERISTICS:

- Life expectancy > 3 months

PRIOR CONCURRENT THERAPY:

- More than 4 weeks since prior chemotherapy

Study Design


Intervention

Radiation:
radiation therapy


Locations

Country Name City State
United Kingdom Cancer Research UK and University College London Cancer Trials Centre London England

Sponsors (1)

Lead Sponsor Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Local progression-free interval in irradiated field Time form randomisation to tumour progression within the irradiated field up to 5 years after randomisation
Secondary Acute toxicity at 4 weeks after randomization
Secondary Late toxicity from 12 weeks after randomisation up to 5 years
Secondary Tumor response in irradiated area at 12 weeks after randomization at 12 weeks after randomization
Secondary Overall survival up to 5 years after randomisation
Secondary Health economic assessment up to 5 years after randomisation
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