← Back to Search

Anti-metabolites

Radiotherapy for Follicular Lymphoma

Phase 3
Waitlist Available
Research Sponsored by Trans Tasman Radiation Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up main analysis after at least 3 years of follow-up following the end of accrual. an updated analysis may be done on completion of 5 years follow-up after the end of accrual. long term follow-up analysis is planned after 10 years of follow-up
Awards & highlights

Study Summary

This trial is studying whether adding chemotherapy and rituximab to standard radiotherapy improves outcomes for patients with early-stage follicular lymphoma.

Eligible Conditions
  • Follicular Lymphoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~main analysis after at least 3 years of follow-up following the end of accrual. an updated analysis may be done on completion of 5 years follow-up after the end of accrual
This trial's timeline: 3 weeks for screening, Varies for treatment, and main analysis after at least 3 years of follow-up following the end of accrual. an updated analysis may be done on completion of 5 years follow-up after the end of accrual for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease
Secondary outcome measures
Acute and late toxicities and secondary malignances
Freedom from progression.
Location of first relapse
+3 more

Side effects data

From 2016 Phase 3 trial • 854 Patients • NCT00003389
98%
Anemia
93%
Leukocytes decreased
90%
Lymphopenia
84%
Neutrophils decreased
78%
Neuropathy-sensory
75%
Alopecia
74%
Fatigue
67%
Nausea
60%
Hyperglycemia
52%
Constipation
46%
Hypoalbuminemia
40%
Myalgia
34%
Stomatitis
33%
Insomnia
32%
Vomiting
27%
Platelets decreased
26%
Alkaline phosphatase increased
26%
Aspartate aminotransferase increased
23%
Dyspnea
20%
Dyspepsia
19%
Dysphagia
19%
Headache
16%
Anorexia
16%
Arthralgia
15%
Neuropathy-motor
15%
Abdominal pain
14%
Infection w/o neutropenia
14%
Cough
14%
Fever
13%
Rash/desquamation
13%
Diarrhea w/o prior colostomy
12%
Bone pain
11%
Weight gain
11%
Taste disturbance
11%
Anxiety/agitation
10%
Sweating
10%
Radiation dermatitis
9%
Rigors/chills
9%
Dizziness/lightheadedness
9%
Injection site reaction
8%
Hypoglycemia
8%
Dysphagia-esophageal radiation
8%
Blood bilirubin increased
8%
Chest pain
8%
Pain-other
8%
Phlebitis
7%
Creatinine increased
7%
Edema
7%
Pruritus
6%
Hot flashes
6%
Infection w/ grade 3 or 4 neutropenia
6%
Weight loss
5%
Muscle weakness
5%
Depression
5%
Mouth dryness
4%
Transfusion: pRBCs
4%
Pneumonitis/pulmonary infiltrates
3%
Thrombosis/embolism
3%
Febrile neutropenia
3%
Irregular menses
3%
Nail changes
2%
Allergic rhinitis
1%
Allergic reaction
1%
Infection w/ unknown ANC
1%
Syncope
1%
Sinus tachycardia
1%
Dehydration
1%
Neuropathic pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Stanford V)
Arm A (ABVD)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Radiotherapy+ ChemotherapyExperimental Treatment5 Interventions
Involved field Radiotherapy (RT) 30-36 GY plus Cyclophosphamide, Vincristine and Prednisolone (CVP) + rituximab × 6 cycles
Group II: Radiotherapy aloneActive Control1 Intervention
Involved field Radiotherapy (30-36 GY) alone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
FDA approved
Cyclophosphamide
FDA approved
Radiotherapy
2017
Completed Phase 3
~2610
Vincristine
FDA approved
Prednisolone
FDA approved

Find a Location

Who is running the clinical trial?

Australasian Leukaemia and Lymphoma GroupOTHER
14 Previous Clinical Trials
4,234 Total Patients Enrolled
Trans Tasman Radiation Oncology GroupLead Sponsor
48 Previous Clinical Trials
16,479 Total Patients Enrolled
Michael MacManus, MDStudy ChairPeter MacCallum Cancer Centre, Australia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Journal of Clinical OncologyJournal
Randomized Trial of Systemic Therapy After Involved-field Radiotherapy in Patients with Early-stage Follicular Lymphoma: TROG 99.03
MacManus, Michael, Richard Fisher, Daniel Roos, Peter O’Brien, Andrew Macann, Sidney Davis, Richard Tsang, et al.. 2018. “Randomized Trial of Systemic Therapy After Involved-field Radiotherapy in Patients with Early-stage Follicular Lymphoma: TROG 99.03”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2018.77.9892.
clinicaltrials.govStudy
Radiotherapy Versus Radiotherapy Plus Chemotherapy in Early Stage Follicular Lymphoma
2000. "Radiotherapy Versus Radiotherapy Plus Chemotherapy in Early Stage Follicular Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00115700.
~6 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top