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Completed

NCT Number: NCT01635270

Phase 2 Study Evaluating Mid-position Strategy in Radiotherapy Treatment for Patients With a Locally Advanced Non-small Cell Lung Carcinoma

The purpose of this study is to establish on the market and to clinically evaluate a new strategy of treatment for patients with locally advanced non-small cell lung cancer using deformable repositioning of 4D imaging.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Locally Advanced Disease Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-metastatic Disease Non-resectable Disease Radiation Therapy Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Léon Bérard

Lyon, 69373, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 T0 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

Treatment and study plan

mid-position radiation strategy

Radiation

The midP strategy defines the target as the time weighted average tumor position (mid-position) plus an additional margin, computed specifically for each patient, that takes into account the tumor motion in each direction. This strategy can help to safely reduce toxicity while preserving treatment efficacy

ITV

Radiation

The ITV strategy is the conventional one. It consists in defining the target as the volume covering the whole tumor motion.

Primary outcomes

  1. 1 year Progression Free Survival rate

    Time frame: 1 year

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

Secondary outcomes

  1. Local tumor control rate

    Time frame: 1 year and 2 years after the end of irradiation

  2. Overall survival

    Time frame: 1 year and 2 years post irradiation

  3. To determine acute and late pulmonary toxicity in the 2 arms, including respiratory functional exploration

    Time frame: Week1; Week 2; Week3; Week4; Week5; Week6; Week7 during the radiation, then 4 weeks, 3 months; 6 months ,one year and 2 years after the irradiation beginning

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Collaborators

  • CREATIS Laboratory

Registry information

Official study title

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).

Acronym: midP

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Jul 9, 2012
Registry last updated
Feb 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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