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Thoracic NeoplasmsNCT00631839

Prospective Study on Factors Predicting Chemo-Radiotherapy Induced Pulmonary and Esophageal Injury

An observational study of Thoracic Neoplasms, run by Shanghai Cancer Hospital, China at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Thoracic Neoplasms
What is being tested?
Thoracic 3-D Conformal Radiotherapy
Type of treatment
Surgery or procedure
How many people
140 participants
Where
1 siteChina
Study dates
Jan 2002to Oct 2008
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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%)
Show all 15Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University, Cancer Hospital, Department of Radiation Oncology

    Shanghai, 200032

Other trials in China

About this study

Official title: Prospect Study to Evaluate Clinical, Dosimetrical, Functional, Biological and Genetic Factors in Predicting Chemo-Radiotherapy Induced Lung and Esophagus Injury

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

Read the detailed description

We propose a prospective study to investigate the combinational effect of radiotherapeutic dosimetric parameters [mean lung dose and percentage of lung volume receiving at least XGy (Vx)] and biological parameters [interleukin-1α(IL1α),interleukin-1β(IL1β),interleukin-6(IL6),interleukin-7(IL7),transforming growth factor beta (TGFB)] and manganese superoxide dismutase(MnSOD) in predicting radiation pneumonitis, fibrosis, and radiation esophageal injury. Eligibility included pathological or cytological proven thoracic cancer,ECOG performance status [PS] 0-2, no prior thoracic RT or chemotherapy,no distant metastasis and signed informed consent prior to study entry.

Basic pre-treatment information will be collected, which included ECOG PS, UICC/AJCC stage,primary lesion site, history of smoking/coexisting lung disease/surgical resection, and pulmonary function test of FEV1/VC/DLCO. Computed tomography [CT] of the whole lung in treatment position. Blood test of IL1α,IL1β,IL6,IL7,TGFB and MnSOD by ELISA will be done before and weekly during RT. RT must be given by photon energies >=6MV. Radiation lung and esophageal injury will be assessed according to common toxicity criteria adverse effect version3.0 [CTCAE-3.0] during RT and in every follow up visits. Genomic DNA is obtained from the blood drawn during RT. Chi-square test, T test, analysis of variance, logistic regression, and proportional hazard ratio method will be used to investigate whether the parameter(s) can be effective in predicting radiation related sequelae.

Being tested
Thoracic 3-D Conformal Radiotherapy
Keywords
Thoracic Neoplasms, Platinum-based chemotherapy, 3-D Conformal Radiotherapy, Chemo-radiotherapy induced lung injury, Chemo-radiotherapy induced esophagus injury
Medical subject headings
Thoracic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thoracic 3-D Conformal RadiotherapyRadiation

    Also called Thoracic Radiotherapy(TRT)

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

Study groups in NCT00631839
Study groupRoleWhat they receive
1There 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.
Receives: Radiation: Thoracic 3-D Conformal Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2008 (estimated)
  2. Study startJan 2002
  3. Primary completionJan 2006
  4. Study completionOct 2008 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00631839
Sponsor's protocol ID
FDCA002
Status last verified
Oct 2008
First submitted
2 Mar 2008
Last updated
7 Oct 2008
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Thoracic Neoplasms, run by Shanghai Cancer Hospital, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chemo-Radiotherapy induced pneumonitis,fibrosis and esophagus injury assessed with common toxicity criteria adverse effect version3.0 [CTCAE-3.0] (time frame: from the begining of treatment to the end of follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00631839.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2008.

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