Radiotherapy versus radiotherapy plus chemotherapy in early stage follicular lymphoma

Trans Tasman Radiation Oncology Group (TROG) 99.03 - A randomised multicentre trial of involved field radiotherapy versus involved field radiotherapy plus chemotherapy (cyclophosphamide, vincristine Prednisolone) in combination with Rituximb (Mabthera) for stage I-II low grade follicular lymphoma to improve progression free survival

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000112460

Acronym

TROG 99.03

Enrollment

150

Registered

2000-07-14

Start date

2000-02-14

Completion date

2012-07-12

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 plus chemotherapy). The main endpoint is progression free survival but overall survival and the influence of t(14;18) status will also be studied.

Interventions

Arm 1: Involved field radiotherapy 30-36Gy. Daily fractions of 1.5-2.0 Gy. Will be given 5 days per week. Cyclophosphamide 1000mg per metre squared IV on day 1. Vincristine 1.4mg per metre squared IV on day 1, Prednisolone 50mg per metre squared orally for days 1-5, Rituximab 375mg per metre squared IV infusion day 1. A total of six 21 day cycles of CVP plus rituximab should be administered.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

- Adult patients (= 18 years old) with histologically documented “follicular lymphoma, grade 1", "follicular lymphoma, 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 - White Cell Count (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 criteria

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 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. - 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 - Suspected or confirmed pregnancy. Must not be lactating.

Outcome results