NCT00136474

Brief Summary

The purpose of this study is determine the effects (good and bad) amifostine has on radiation-induced side effects of lymphoma treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P75+ for phase_2 lymphoma

Timeline
Completed

Started May 2003

Geographic Reach
1 country

2 active sites

Status
completed

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

May 1, 2003

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

November 2, 2009

Status Verified

October 1, 2009

Enrollment Period

2 years

First QC Date

August 25, 2005

Last Update Submit

October 30, 2009

Conditions

LymphomaHodgkin's DiseaseNon-Hodgkin's Lymphoma

Keywords

LymphomaRadiation therapyAmifostine

Outcome Measures

Primary Outcomes (1)

  • To evaluate the effectiveness of amifostine in reducing acute and chronic radiation-induced side effects

    2 years

Secondary Outcomes (2)

  • To determine the quality-of-life of patients receiving radiation therapy and amifostine

  • to determine the safety of amifostine

    2 years

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Amifostine plus radiation therapy

Drug: AmifostineRadiation: Radiation Therapy

Group 2

ACTIVE COMPARATOR

Radiation therapy alone

Radiation: Radiation Therapy

Interventions

AmifostineDRUG

Given 30-60 minutes prior to daily radiation therapy

Group 1
Radiation TherapyRADIATION

Daily radiation therapy

Group 1Group 2

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must be 35 years or older
  • Histologically confirmed Hodgkin's disease or non-Hodgkin's lymphoma receiving radiation therapy to the head and neck area.
  • Involvement of one or more of the following sites: cervical node, supraclavicular node, pre-auricular node, submental node, any salivary glands, any parts of the oral cavity, or any parts of the oropharynx.

You may not qualify if:

  • Prior history of head and neck malignancies
  • Prior radiation therapy to the head and neck region
  • Patients with stage I Hodgkin's disease receiving radiation therapy alone
  • Pregnant or lactating women
  • Myocardial infarction within the 6 months of enrollment
  • Clinically evident pulmonary insufficiency, except for patients with exertional dyspnea related to chest tumor itself.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

LymphomaHodgkin DiseaseLymphoma, Non-Hodgkin

Interventions

AmifostineRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

OrganothiophosphatesOrganophosphatesOrganophosphorus CompoundsOrganic ChemicalsOrganothiophosphorus CompoundsSulfur CompoundsTherapeutics

Study Officials

  • Andrea K. Ng, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 29, 2005

Study Start

May 1, 2003

Primary Completion

May 1, 2005

Study Completion

March 1, 2009

Last Updated

November 2, 2009

Record last verified: 2009-10

Locations

US(2)