NCT00631839

Brief Summary

The purpose of this study is to evaluate clinical, dosimetrical, functional, biological and genetic factors in predicting chemo-radiotherapy induced lung and esophagus injury.

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
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

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

January 1, 2002

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 10, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

October 7, 2008

Status Verified

October 1, 2008

Enrollment Period

4 years

First QC Date

March 2, 2008

Last Update Submit

October 6, 2008

Conditions

Thoracic Neoplasms

Keywords

Thoracic NeoplasmsPlatinum-based chemotherapy3-D Conformal RadiotherapyChemo-radiotherapy induced lung injuryChemo-radiotherapy induced esophagus injury

Outcome Measures

Primary Outcomes (1)

  • Chemo-Radiotherapy induced pneumonitis,fibrosis and esophagus injury assessed with common toxicity criteria adverse effect version3.0 [CTCAE-3.0]

    from the begining of treatment to the end of follow-up

Study Arms (1)

1

There is only one group in this study. The patients of this group will go through procedures as follow: basic pre-treatment information collected,treatment include platinum-based chemotherapy and 3-D conformal radiotherapy, blood test during RT 6am every Monday and follow-up visits with treatment-induced injury assessed.

Radiation: Thoracic 3-D Conformal Radiotherapy

Interventions

Thoracic 3-D Conformal RadiotherapyRADIATION

Thoracic RT tailored for each patient, about 60Gy (NSCLC) or 55Gy (SCLC) with photon energies \>=6MV.

Also known as: Thoracic Radiotherapy(TRT)
1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients enrolled are Chinese with thoracic neoplasms, no distant metastasis and initially treated.

You may qualify if:

  • Non-pregnant adults (18\<= age \<= 75 y/o)
  • Chinese ethnicity
  • Pathological or cytological proven thoracic neoplasms (of note,sputum cytology alone is not acceptable.Cytological specimens obtained by brushing,washing and needle aspiration of a defined lesion are acceptable)
  • Initially treated
  • No distant metastasis
  • ECOG PS 0-2 (Karnofsky\>60%)
  • Understand and willing to sign the consent
  • Normal organ and marrow function as defined below:
  • Leukocytes \>=3,000/µL
  • Haemoglobin \>=9 g/dL (prior to transfusions)
  • Absolute neutrophil count \>=1,500/µL
  • Platelets \>=100,000/µL
  • Total bilirubin \< 1.5 x upper limit of normal
  • AST (SGOT)/ALT (SGPT) ≤2.5 X institutional upper limit of normal
  • Creatinine \<=2.5 mg/dl.

You may not qualify if:

  • Prior thoracic radiotherapy
  • Distant metastasis
  • Allergic reactions attributed to compounds of similar chemical or biologic composition to platinum-based drugs.
  • Pre-existed non-oncological pulmonary or esophageal disease that may put the patient at high risk of severe toxicities.
  • Other uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and psychiatric illness/social situations that would limit compliance with study requirement
  • pregnancy or lactating
  • Receiving other investigational agents or devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University, Cancer Hospital, Department of Radiation Oncology

Shanghai, 200032, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Patients' blood samples will be retained for the purpose of cytokine and MnSOD assay and DNA detection. The samples will be left till the study ends. Paitents will have their vein blood drawn from left arm 6am every Monday during RT. All above is stated in informed consent form.

MeSH Terms

Conditions

Thoracic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Min Fan, MD

    Fudan University Cancer Hospital, Department of Radiation Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 2, 2008

First Posted

March 10, 2008

Study Start

January 1, 2002

Primary Completion

January 1, 2006

Study Completion

October 1, 2008

Last Updated

October 7, 2008

Record last verified: 2008-10

Locations

CN(1)