Status:
COMPLETED
Radiotherapy Versus Radiotherapy Plus Chemotherapy in Early Stage Follicular Lymphoma
Lead Sponsor:
Trans Tasman Radiation Oncology Group
Collaborating Sponsors:
Australasian Leukaemia and Lymphoma Group
Conditions:
Follicular Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 chemothera...
Detailed 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 o...
Eligibility Criteria
Inclusion
- Adult patients (≥ 18 years old) with histologically documented "follicular lymphoma, grade 1", grade 2", or "follicular lymphoma, grade 3a" diagnosed following an excisional, 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 pregnant during participating in the trial and during the 12 months thereafter. Men agree not to father a child during participation in the trial and during the 12 months thereafter.
Exclusion
- Received previous systemic cytotoxic chemotherapy.
- Received previous radiotherapy, (except superficial radiation therapy for non-melanoma skin cancers).
- Received previous immunotherapy.
- A medical contraindication to radiotherapy, chemotherapy, or rituximab.
- Any previous or concurrent malignancy other than curatively treated non-melanoma skin cancer, level 1 malignant melanoma, or in situ cervical cancer, unless disease and treatment-free for 5 years.
- Such extensive involvement of the thorax that treatment with radiation therapy alone would be hazardous because of excessive lung irradiation, even if a shrinking field technique were employed.
- Suspected or confirmed pregnancy. Must not be lactating.
- Patients who have known human immuno-deficiency virus (HIV) infection or active hepatitis B (HBV).
- Treatment within a clinical study within 30 days prior to study entry.
Key Trial Info
Start Date :
February 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2018
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00115700
Start Date
February 1 2000
End Date
August 1 2018
Last Update
November 18 2022
Active Locations (21)
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1
The Canberra Hospital
Garran, Australian Capital Territory, Australia, 2605
2
Calvary Mater Newcastle
Newcastle, New South Wales, Australia, 2298
3
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
4
Westmead Hospital
Wentworthville, New South Wales, Australia, 2145