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Phase 3 Study of 30Gy Versus 40Gy Involved-field Radiotherapy in Localized Diffuse Large B Cell Lymphoma Achieving CR After Chemotherapy


Phase 3
15 Years
N/A
Open (Enrolling)
Both
Lymphoma, Large B-Cell, Diffuse

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Trial Information

Phase 3 Study of 30Gy Versus 40Gy Involved-field Radiotherapy in Localized Diffuse Large B Cell Lymphoma Achieving CR After Chemotherapy


The best proper doses of IFRT in combined modality treatments (CMT) for localized DLBCL is
still undetermined. Existing treatment guidelines recommend 40Gy or above as the standard
treatment dosage. However, there were large-scaled clinical trials implying smaller doses
such as 30Gy may be equivalent effective. Lowering radiation doses can decrease treatment
toxicities and radiotherapy-induced diseases, which has been conformed by HD13 study for
Hodgkin's Lymphoma. It may even retain the truth when modern era radiation techniques are
involved and especially in patients achieving CR after chemotherapy. A comprehensive,
prospective dose-comparing study is needed.


Inclusion Criteria:



- biopsy-proved Diffuse Large B cell lymphoma

- nonbulky stage I, nonbulky stage IE, nonbulky stage II, or nonbulky stage IIE
disease(Bulky disease was defined as a mass 10 cm or more in maximal diameter)
according to Ann Arbor Staging

- provide written informed consent

- Complete regression after chemotherapy

- Considerable to CT simulation and 3D CRT or IMRT

- Performance status 0-2 WHO criteriaï¼›life expectation>6 months

- negative for human immunodeficiency virus syndrome (HIV)

- Minimal staging included chest radiograph, computed tomography of the abdomen and
pelvis, and single percutaneous bone marrow biopsy and blood studies

Exclusion Criteria:

- primary mediastinal large B cell lymphoma

- dermatological lymphoma

- testicular lymphoma

- primary central nerve system lymphoma

- prior RT

- history of low-grade lymphoma congestive

- history of heart failure (CHF; New York Heart Association [NYHA] classifications
III-IV), history of neoplasm (adequately treated basal cell carcinoma of the skin or
in situ carcinoma of the uterine cervix were allowed), abnormal liver function tests
(aminotransferases and alkaline phosphatase > 2.5 times the upper limit of normal,
bilirubin > 50 ), renal insufficiency (serum creatinine > 300 ), and patients with
any serious medical or psychiatric illness that would prevent informed consent or
completion of protocol-prescribed treatment and follow-up

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

disease free survival

Outcome Time Frame:

five years

Safety Issue:

No

Principal Investigator

Yexiong Li, MD

Investigator Role:

Study Director

Investigator Affiliation:

Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Authority:

China: Federal Institute for Drugs and Medical Devices

Study ID:

CH-LYM-004

NCT ID:

NCT01156259

Start Date:

April 2010

Completion Date:

May 2015

Related Keywords:

  • Lymphoma, Large B-Cell, Diffuse
  • B cell cll/lymphoma, human
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

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