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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years from registration

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression free survival (PFS)

Secondary outcome measures

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%

Hair loss/Alopecia (scalp or body)

26%

Mucositis/stomatitis (clinical exam) - Oral cavity

25%

Pain - Head/headache

24%

Albumin, serum-low (hypoalbuminemia)

24%

Rigors/chills

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%

Bilirubin (hyperbilirubinemia)

17%

Pain - Abdomen NOS

17%

Rash/desquamation

15%

Calcium, serum-low (hypocalcemia)

14%

Sodium, serum-low (hyponatremia)

13%

Edema: limb

13%

Hemorrhage, pulmonary/upper respiratory - Nose

12%

Creatinine

12%

Constipation

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)

Taste alteration (dysgeusia)

Hypotension

Phosphate, serum-low (hypophosphatemia)

Metabolic/Laboratory-Other (Specify)

Allergic reaction/hypersensitivity (including drug fever)

Cough

Hemorrhage, CNS

Hemorrhage, pulmonary/upper respiratory - Lung

Adult respiratory distress syndrome (ARDS)

Liver dysfunction/failure (clinical)

Pleural effusion (non-malignant)

Hemorrhage, GU - Kidney

Hypoxia

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.

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 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

International Extranodal Lymphoma Study Group (IELSG)Lead Sponsor

27 Previous Clinical Trials

3,233 Total Patients Enrolled

Maurizio Martelli, MDStudy ChairUniversità La Sapienza (Rome - Italy)

3 Previous Clinical Trials

484 Total Patients Enrolled

Andrew J Davies, MDStudy ChairUniversity of Southampton (UK)

Media Library

observation Clinical Trial Eligibility Overview. Trial Name: NCT01599559 — N/A

B-Cell Lymphoma Research Study Groups: mediastinal irradiation, observation

B-Cell Lymphoma Clinical Trial 2023: observation Highlights & Side Effects. Trial Name: NCT01599559 — N/A

observation 2023 Treatment Timeline for Medical Study. Trial Name: NCT01599559 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the current sites in which this clinical trial is available?

"Presently, this scientific investigation is being conducted at four distinct sites. These include Rochester, Houston and Louisville among others. It is prudent to select the nearest clinical centre in order to limit travel demands if you join the trial."

Answered by AI

Are there any unfilled opportunities for participants in this clinical experiment?

"According to clinicaltrials.gov, this specific medical trial is no longer actively seeking participants. The investigation was initially published on October 1st 2012 and last modified on November 4th 2022. However, there are presently 1746 other studies that are recruiting patients at large."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Randomized, Open-label, Two-arms, Phase III Comparative Study Assessing the Role of Involved Mediastinal Radiotherapy After Rituximab Containing Chemotherapy Regimens to Patients With Newly Diagnosed Primary Mediastinal Large B-Cell Lymphoma

2012. "Randomized, Open-label, Two-arms, Phase III Comparative Study Assessing the Role of Involved Mediastinal Radiotherapy After Rituximab Containing Chemotherapy Regimens to Patients With Newly Diagnosed Primary Mediastinal Large B-Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01599559.