Radiotherapy Versus Radiotherapy Plus Chemotherapy in Early Stage Follicular Lymphoma

Last updated: November 16, 2022
Sponsor: Trans Tasman Radiation Oncology Group
Overall Status: Completed

Phase

3

Condition

Lymphoma

Lymphoproliferative Disorders

Follicular Lymphoma

Treatment

N/A

Clinical Study ID

NCT00115700
TROG 99.03
ALLG NHLLOW5
  • Ages > 18
  • All Genders

Study Summary

Patients with stage I and II low grade follicular lymphoma are randomised between standard therapy (involved field radiotherapy) and investigational therapy (involved field radiotherapy and chemotherapy plus rituximab). The main endpoint is progression free survival but overall survival and the influence of t(14;18) status will also be studied.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients (≥ 18 years old) with histologically documented "follicular lymphoma,grade 1", grade 2", or "follicular lymphoma, grade 3a" diagnosed following anexcisional, incisional or generous core biopsy. (i.e. an FNA alone is insufficient.)
  • Disease limited to stages I and II after adequate staging
  • Anticipated life expectancy > 5 years
  • Given written informed consent
  • Been assessed by a radiation oncologist and a medical oncologist/ haematologist
  • WCC > 3.0 x 10^9/L, platelet count > 100 x 10^9/L, serum creatinine < 0.15 mmol/L
  • Ability to commence radiotherapy within 6 weeks of randomisation
  • Women using effective contraception, are not pregnant and agree not to become pregnantduring participating in the trial and during the 12 months thereafter. Men agree notto father a child during participation in the trial and during the 12 monthsthereafter.

Exclusion

Exclusion Criteria:

  • Received previous systemic cytotoxic chemotherapy.
  • Received previous radiotherapy, (except superficial radiation therapy for non-melanomaskin cancers).
  • Received previous immunotherapy.
  • A medical contraindication to radiotherapy, chemotherapy, or rituximab.
  • Any previous or concurrent malignancy other than curatively treated non-melanoma skincancer, level 1 malignant melanoma, or in situ cervical cancer, unless disease andtreatment-free for 5 years.
  • Such extensive involvement of the thorax that treatment with radiation therapy alonewould be hazardous because of excessive lung irradiation, even if a shrinking fieldtechnique were employed.
  • Suspected or confirmed pregnancy. Must not be lactating.
  • Patients who have known human immuno-deficiency virus (HIV) infection or activehepatitis B (HBV).
  • Treatment within a clinical study within 30 days prior to study entry.

Study Design

Total Participants: 150
Study Start date:
February 01, 2000
Estimated Completion Date:
August 31, 2018

Study Description

Radiotherapy is the only modality which has been proven to have curative potential in patients with localised low grade lymphoma. Despite excellent control of the local tumour, most patients relapse outside the area treated with radiation and most of these ultimately die from lymphoma. This study tests the hypothesis that the addition of six cycles of chemotherapy plus rituximab (systemic chemotherapy) can eradicate undetectable lymphoma deposits outside the radiation field and thereby improve the cure rate. The study will specifically test the hypothesis that six cycles of adjuvant CVP chemotherapy (cyclophosphamide, vincristine, prednisolone) in combination with Rituximab will improve progression-free survival for patients with stage I and II low-grade follicular lymphoma treated with involved-field radiotherapy (IFRT). That is, will patients given radiotherapy plus systemic chemotherapy live longer or remain free from disease longer than patients treated with radiation alone? Radiotherapy alone is widely regarded as the standard treatment for this disease.

There are a number of secondary endpoints to the study, as follows:

  1. Comparison the pre- and post-treatment prevalence of the t(14:18) translocation, in peripheral blood and bone marrow, of patients treated with either IFRT alone or IFRT plus chemotherapy. This translocation is potentially a marker for minimal residual disease and eradication of the marker from blood cells may have prognostic implications. The clinical value of "molecular remission" as an early predictor of freedom from progression (FFP) and survival will be assessed.

  2. Comparison of overall survival and FFP for patients treated with IFRT alone with overall survival and FFP for patients treated with combined IFRT and systemic therapy. Delay of progression of disease may be of limited value if overall survival is the same.

  3. Comparison of acute and late toxicity and second malignancy rates for patients treated with IFRT or IFRT plus systemic therapy.

  4. Delineation of the location of first relapse in relation to radiation therapy fields.

Connect with a study center

  • The Canberra Hospital

    Garran, Australian Capital Territory 2605
    Australia

    Site Not Available

  • Albury Base/Murray Valley Private Hospital

    Albury/Wodonga, New South Wales 2640/3690
    Australia

    Site Not Available

  • Calvary Mater Newcastle

    Newcastle, New South Wales 2298
    Australia

    Site Not Available

  • Prince of Wales Hospital

    Randwick, New South Wales 2031
    Australia

    Site Not Available

  • Westmead Hospital

    Wentworthville, New South Wales 2145
    Australia

    Site Not Available

  • Albury Base/Murray Valley Private Hospital

    West Albury, New South Wales 2640
    Australia

    Site Not Available

  • Illawarra Cancer Care Centre

    Wollongong, New South Wales 2500
    Australia

    Site Not Available

  • Radiation Oncology - Mater Centre

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Genesis Cancer Care (previously Premion)

    Tugun, Queensland 4224
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • The Queen Elizabeth Hospital

    Woodville, South Australia 5011
    Australia

    Site Not Available

  • Launceston General Hospital

    Launceston, Tasmania 7250
    Australia

    Site Not Available

  • St John of God Hospital

    Ballarat, Victoria 3350
    Australia

    Site Not Available

  • Peter MacCallum Cancer Centre

    East Melbourne, Victoria 3002
    Australia

    Site Not Available

  • Andrew Love Cancer Care Centre, Geelong Hospital

    Geelong, Victoria 3220
    Australia

    Site Not Available

  • Austin Health

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • Murray Valley Private Hospital

    Wodonga, Victoria 3690
    Australia

    Site Not Available

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Princess Margaret Hospital

    Toronto,
    Canada

    Site Not Available

  • Auckland Hospital

    Auckland, 1001
    New Zealand

    Site Not Available

  • Christchurch Hospital

    Christchurch, 8011
    New Zealand

    Site Not Available

  • Waikato Hospital

    Hamilton, 3200
    New Zealand

    Site Not Available

  • Wellington Hospital

    Wellington, 7902
    New Zealand

    Site Not Available

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