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A Phase III Multi-Center Randomized Controlled Trial of Low-Dose Radiotherapy for Follicular Lymphoma and Marginal Zone Lymphoma


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

A Phase III Multi-Center Randomized Controlled Trial of Low-Dose Radiotherapy for Follicular Lymphoma and Marginal Zone 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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Local progression-free interval in irradiated field

Outcome Description:

Time form randomisation to tumour progression within the irradiated field

Outcome Time Frame:

up to 5 years after randomisation

Safety Issue:

No

Authority:

United Kingdom: NHS Health Research Authority

Study ID:

UCL/05/84

NCT ID:

NCT00310167

Start Date:

October 2005

Completion Date:

July 2016

Related Keywords:

  • Lymphoma
  • stage I grade 1 follicular lymphoma
  • stage I grade 2 follicular lymphoma
  • stage I grade 3 follicular lymphoma
  • contiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • Marginal zone lymphoma
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell, Marginal Zone

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