Positron Emission Tomography and Computed Tomography in Planning Treatment for Patients Undergoing 3-Dimensional Conformal Radiation Therapy for Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery. ICORG 06-35

This study has been terminated.
(Low levels of recruitment)
Sponsor:
Information provided by (Responsible Party):
ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00958321
First received: August 12, 2009
Last updated: April 16, 2014
Last verified: January 2014
  Purpose

RATIONALE: Diagnostic procedures, such as positron emission tomography and computed tomography, may help learn the extent of disease and allow doctors to plan 3-dimensional conformal radiation therapy.

PURPOSE: This phase II trial is studying the side effects of positron emission tomography and computed tomography and to see how well it works in planning treatment for patients undergoing 3-dimensional conformal radiation therapy for non-small cell lung cancer that cannot be removed by surgery.

This is a clinical study, as the patient will be treated using the PET-CT-GTV: - The pilot study is investigating the technological feasibility - The Phase II study will be a 2-stage Phase II study


Condition Intervention Phase
Lung Cancer
Metastatic Cancer
Procedure: computed tomography
Radiation: 3-dimensional conformal radiation therapy
Radiation: fludeoxyglucose F 18
Radiation: radiation therapy treatment planning/simulation
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prospective Evaluation of PET-CT Scan in Patients With Non-operable or Non-resectable NSCLC Treated by Radical 3-Dimensional Conformal Radiation Therapy

Resource links provided by NLM:


Further study details as provided by ICORG- All Ireland Cooperative Oncology Research Group:

Primary Outcome Measures:
  • Rate of successful delivery of PET-CT scan based 3-D conformal radiotherapy (Pilot) [ Time Frame: 2016 ] [ Designated as safety issue: No ]
  • Rate of loco-regional recurrence outside the PET-CT planning target volume (PTV) but within conventional 3-D PTV (Phase II) [ Time Frame: 2016 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acute and long-term radiation-induced toxicity [ Time Frame: 2016 ] [ Designated as safety issue: Yes ]
  • Comparison of dose delivery to organs at risk, according to planning method [ Time Frame: 2016 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2007
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3-DCRT
Patients will receive a total dose of 60-66 Gy in 30-33 fractions with 3-DCRT
Procedure: computed tomography Radiation: 3-dimensional conformal radiation therapy Radiation: fludeoxyglucose F 18 Radiation: radiation therapy treatment planning/simulation

Detailed Description:

Pilot Study- Primary Objectives:

  • Prospective evaluation of the technical feasibility of integrating PET-CT fusion in St Luke's Hospital
  • Rate of PET-CT Scan based treatment delivery

Pilot Study- Secondary Objectives:

-Comparison of GTV, PTV and OAR DVHs between conventional 3-DCRT plan and PET-CT based 3-DCRT plan.

Phase II Study- Primary Objective:

-The safety of PET-CT scan based radiotherapy, with regard to loco-regional disease control.

Phase II Study- Secondary Objectives:

-Comparison of GTV, PTV and OAR DVHs between conventional 3-DCRT plan and PET-CT based 3-DCRT plan.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven (biopsy or cytology) NSCLC (SCC, Adenocarcinoma, Large Cell)
  • TNM clinical non-operable stage I/II and non-resectable stage IIIa/b without pleural effusion
  • Measurable disease
  • No other malignancy, except non-melanomatous skin cancer, within 5 years prior to participation in this study; the disease-free interval from any prior carcinoma must be continuous
  • Patient suitable for radical 3-DCRT
  • ECOG-Performance status ≤ 2 / KPS > or equal to 60
  • Weight loss <10% within the 3 months prior to diagnosis
  • No prior radiotherapy to the thorax
  • Patient is suitable for lung-board immobilisation
  • No chemotherapy received prior to planning PET-CT scan
  • Age 18 and over
  • Provision of written informed consent

Exclusion Criteria:

  • Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial or if it is felt by the research / medical team that the patient may not be able to comply with the protocol.
  • FEV1 < 1
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00958321

Locations
Ireland
St Luke's Radiation Oncology Network
Dublin, Ireland, 6
Sponsors and Collaborators
ICORG- All Ireland Cooperative Oncology Research Group
Investigators
Principal Investigator: Pierre Thirion, MD Saint Luke's Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier: NCT00958321     History of Changes
Other Study ID Numbers: CDR0000639298, ICORG-06-35, EU-20925
Study First Received: August 12, 2009
Last Updated: April 16, 2014
Health Authority: Ireland: Research Ethics Committee

Keywords provided by ICORG- All Ireland Cooperative Oncology Research Group:
adenocarcinoma of the lung
large cell lung cancer
squamous cell lung cancer
malignant pleural effusion
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IA non-small cell lung cancer
stage IB non-small cell lung cancer
stage IIA non-small cell lung cancer
stage IIB non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Fluorodeoxyglucose F18
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014