Low-Dose Radiation Therapy in Treating Patients With Follicular or Marginal Zone Non-Hodgkin's Lymphoma (FoRT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT00310167
First received: March 29, 2006
Last updated: March 26, 2013
Last verified: March 2013

March 29, 2006
March 26, 2013
October 2005
July 2016   (final data collection date for primary outcome measure)
Local progression-free interval in irradiated field [ Time Frame: up to 5 years after randomisation ] [ Designated as safety issue: No ]
Time form randomisation to tumour progression within the irradiated field
Not Provided
Complete list of historical versions of study NCT00310167 on ClinicalTrials.gov Archive Site
  • Acute toxicity [ Time Frame: at 4 weeks after randomization ] [ Designated as safety issue: Yes ]
  • Late toxicity [ Time Frame: from 12 weeks after randomisation up to 5 years ] [ Designated as safety issue: Yes ]
  • Tumor response in irradiated area at 12 weeks after randomization [ Time Frame: at 12 weeks after randomization ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: up to 5 years after randomisation ] [ Designated as safety issue: No ]
  • Health economic assessment [ Time Frame: up to 5 years after randomisation ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Low-Dose Radiation Therapy in Treating Patients With Follicular or Marginal Zone Non-Hodgkin's Lymphoma
A Phase III Multi-Center Randomized Controlled Trial of Low-Dose Radiotherapy for Follicular Lymphoma and Marginal Zone Lymphoma

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
Radiation: radiation therapy
  • Experimental: 4 Gy
    4 Gy in 2 fractions
    Intervention: Radiation: radiation therapy
  • Active Comparator: 24 Gy
    24 Gy in 12 fractions
    Intervention: Radiation: radiation therapy
Hoskin PJ, Kirkwood AA, Popova B, Smith P, Robinson M, Gallop-Evans E, Coltart S, Illidge T, Madhavan K, Brammer C, Diez P, Jack A, Syndikus I. 4 Gy versus 24 Gy radiotherapy for patients with indolent lymphoma (FORT): a randomised phase 3 non-inferiority trial. Lancet Oncol. 2014 Apr;15(4):457-63. doi: 10.1016/S1470-2045(14)70036-1. Epub 2014 Feb 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
614
July 2016
July 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00310167
UCL/05/84, CRUK-FORT, CRUK-BRD/05/84, EUDRACT-2005-002416-19, ISRCTN65687030, EU-20601
Yes
University College, London
University College, London
Not Provided
Not Provided
University College, London
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP