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Radiation Therapy vs Observation for B-Cell Lymphoma

N/A

Waitlist Available

Research Sponsored by International Extranodal Lymphoma Study Group (IELSG)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Fit to receive chemotherapy and radiotherapy with curative intent

Age at least 18 years

Must not have

History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years from registration

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether radiation therapy is necessary for patients with primary mediastinal large B cell lymphoma who have no active tumor residue following chemoimmunotherapy, by comparing radiation therapy with careful observation.

Who is the study for?

Adults with newly diagnosed primary mediastinal large B-cell lymphoma, CD20 positive, without extranodal disease outside the chest. They must have completed chemoimmunotherapy without autologous stem cell support and show no active tumor on PET/CT. Excludes pregnant women, those with certain psychological or medical conditions, HIV-positive individuals, and recent history of other cancers.

What is being tested?

This trial is testing if radiation therapy after chemoimmunotherapy is necessary for patients whose PET/CT scans don't show active tumors. Participants are randomly assigned to either receive radiation treatment or undergo careful observation to compare progression-free survival rates.

What are the potential side effects?

Potential side effects from radiation therapy may include skin changes at the treated area, fatigue, nausea, difficulty swallowing due to inflammation in the throat area (esophagitis), and potential long-term risks like heart complications or secondary cancers.

Eligibility Criteria

Inclusion Criteria

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

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I am considered healthy enough to undergo chemotherapy and radiotherapy aimed at curing my condition.

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I am 18 years old or older.

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I am receiving Rituximab with anthracycline chemotherapy but not stem cell support.

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My cancer has not spread outside my chest, spleen, or bone marrow.

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I have a type of lymphoma that has not been treated yet.

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My cancer diagnosis was confirmed with specific tests and I have a major tumor in the front of my chest area.

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I have received at least 6 treatments with Rituximab.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had cancer, except for specific skin cancers or cervical pre-cancer, in the last 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years from registration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 years from registration

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years from registration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression free survival (PFS)

Secondary study objectives

Long term toxicity

Overall survival (OS)

Side effects data

From 2014 Phase 3 trial • 637 Patients • NCT00085709

59%

Febrile neutropenia

56%

Nausea

48%

Fatigue (asthenia, lethargy, malaise)

46%

Platelets

43%

AST, SGOT (serum glutamic oxaloacetic transaminase)

42%

ALT, SGPT (serum glutamic pyruvic transaminase)

40%

Hemoglobin

39%

Diarrhea

37%

Neutrophils/granulocytes (ANC/AGC)

34%

Leukocytes (total WBC)

32%

Vomiting

29%

Anorexia

27%

Alkaline phosphatase

27%

Glucose, serum-high (hyperglycemia)

26%

Mucositis/stomatitis (clinical exam) - Oral cavity

26%

Hair loss/Alopecia (scalp or body)

25%

Pain - Head/headache

24%

Rigors/chills

24%

Albumin, serum-low (hypoalbuminemia)

19%

Fever (in the absence of neutropenia, where neutropenia is defined as ANC lt1.0 x 10e9/L)

19%

Potassium, serum-low (hypokalemia)

18%

Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)

17%

Pain - Abdomen NOS

17%

Bilirubin (hyperbilirubinemia)

17%

Rash/desquamation

15%

Calcium, serum-low (hypocalcemia)

14%

Sodium, serum-low (hyponatremia)

13%

Edema: limb

13%

Hemorrhage, pulmonary/upper respiratory - Nose

12%

Constipation

12%

Creatinine

11%

Mucositis/stomatitis (functional/symptomatic) - Oral cavity

11%

Dyspnea (shortness of breath)

11%

Lymphopenia

Hemorrhage/Bleeding-Other (Specify)

Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Blood

Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lung (pneumon

Potassium, serum-high (hyperkalemia)

Hypertension

Magnesium, serum-low (hypomagnesemia)

Phosphate, serum-low (hypophosphatemia)

Taste alteration (dysgeusia)

Hypotension

Allergic reaction/hypersensitivity (including drug fever)

Metabolic/Laboratory-Other (Specify)

Cough

Hemorrhage, CNS

Adult respiratory distress syndrome (ARDS)

Hemorrhage, pulmonary/upper respiratory - Lung

Liver dysfunction/failure (clinical)

Hemorrhage, GU - Kidney

Hypoxia

Pleural effusion (non-malignant)

Pneumonitis/pulmonary infiltrates

100%

80%

60%

40%

20%

Study treatment Arm

Induction 7 + 3 + G.O.

Induction 7 + 3

Ara-C Consolidation

Post-consolidation G.O.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: observationExperimental Treatment1 Intervention

Follow up visits are scheduled from randomization. Patients will be seen at 3-months intervals for 24 months, then every 6 months until 5 years from randomization.

Group II: mediastinal irradiationActive Control1 Intervention

Radiotherapy will be delivered in this phase III protocol, as alternative to observation, as consolidation treatment in patients achieving a CR status (PET/CT scan negative) at the end of R-chemotherapy, with a total dose of 30 Gy.

0 / 8Eligibility criteria met