NCT01156259

Brief Summary

The purpose of this study is to determine whether 30Gy Involved-field Radiotherapy (IFRT) is as effective as 40Gy in the treatment of localized Diffused Large B cell Lymphoma (DLBCL) when completing CR after chemotherapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2010

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2010

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

July 2, 2010

Status Verified

April 1, 2010

Enrollment Period

5 years

First QC Date

June 29, 2010

Last Update Submit

July 1, 2010

Conditions

Lymphoma, Large B-Cell, Diffuse

Keywords

B cell cll/lymphoma, human

Outcome Measures

Primary Outcomes (1)

  • disease free survival

    five years

Secondary Outcomes (4)

  • overall survival

    five years

  • acute treatment toxicity

    up to 16 weeks

  • late treatment toxicity

    five years

  • treatment failure type

    five years

Study Arms (2)

30 Gy

EXPERIMENTAL
Radiation: 3D-CRT based Involved Field Radiotherapy

40 Gy

ACTIVE COMPARATOR
Radiation: 3D-CRT based Involved Field Radiotherapy

Interventions

3D-CRT based Involved Field RadiotherapyRADIATION

CT simulation, 3D-CRT or IMRT techniques, Involved Field Radiotherapy of 30Gy

30 Gy

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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 criteria；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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Yexiong Li, MD

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

    STUDY DIRECTOR

Central Study Contacts

YeXiong Li, MD

CONTACT

8610-87788860yexiong3@yahoo.com.cn

Shunan Qi, MD

CONTACT

8610-87725547qishunan@yahoo.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 29, 2010

First Posted

July 2, 2010

Study Start

April 1, 2010

Primary Completion

April 1, 2015

Study Completion

May 1, 2015

Last Updated

July 2, 2010

Record last verified: 2010-04

Locations

CN(1)