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Randomized Phase 2 Study Evaluating the Interest of Mid-position Strategy Versus ITV (Internal Target Volume) Strategy in Radiotherapy Treatment for Patients With a Locally Advanced Non-resected Non-small Cell Lung Carcinoma (NSCLC).


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer, Radiation Therapy, Locally Advanced Disease, Non-metastatic Disease, Non-resectable Disease

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Trial Information

Randomized Phase 2 Study Evaluating the Interest of Mid-position Strategy Versus ITV (Internal Target Volume) Strategy in Radiotherapy Treatment for Patients With a Locally Advanced Non-resected Non-small Cell Lung Carcinoma (NSCLC).


Inclusion Criteria:



- patient with a NSCLC, non-resected, non-metastatic including a parenchyma portion

- Age >= 18 years

- PS <=2

- CT-scan within 3 months at inclusion

- PET-scan within 3 months at inclusion

- Respiratory functional exploration within 3 months at inclusion

- estimated V20 (by radiotherapist)< 35% on conventional pre-radiotherapy imaging

- Tumor T1 to T4, M0; N1, N2 ou N3 by isolateral supra-clavicular involvement

- Measurable disease according to RECIST criteria 1.1

- Curative intent Chest conventional radiation therapy

- Radiation indication validated by a multidisciplinary meeting

- Adequate contraceptive method for the whole study duration and for up to 28 days
after the end of radiation

- Mandatory affiliation with a health insurance company

- Patients must provide dated & written consent

Exclusion Criteria:

- Prior surgery for NSCLC

- NSCLC nearby pulmonary apex or strictly intra-thoracic with no intra-parenchyma
portion

- Metastatic disease or N3 contralateral lymph node

- History of chest irradiation

- History of known increased intrinsic radiosensibility

- Hypersensibility to active substance or excipient of fluoro-deoxyglucose-18F

- Life expectancy < 6 months

- Patient with a concurrent malignancy or with a history of malignancy (excepted
adequately treated basal cell skin carcinoma or cervical squamous cell carcinoma or
other malignancies free of the disease for at least 5 years)

- Pregnant or breastfeeding women

- Psychological, sociological or geographical conditions that would limit compliance
with study requirements

- Patient deprived of freedom

- Patient has concomitant participation to an other investigational study

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

1 year Progression Free Survival rate

Outcome Description:

Efficacy evaluation of the midP strategy in comparaison with ITV strategy in patient with locally advanced, non-resected NSCL cancer treated with radiotherapy

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Line CLAUDE, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Léon Bérard, Lyon, FRANCE

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

midP

NCT ID:

NCT01635270

Start Date:

July 2012

Completion Date:

July 2016

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Radiation Therapy
  • Locally Advanced Disease
  • Non-metastatic Disease
  • Non-resectable Disease
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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