Radiotherapy Dose Complement in the Treatment of Hypoxic Lesions Patients With Stage III Non-small-cell Lung Cancer

NCT01576796 | Unknown Phase 2

• 1 other identifier: CHB11-01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the efficacy and safety of a radiotherapy dose complement (boost) in the treatment of hypoxic lesions, measured by F-miso PET/CT, in patients with stage III NSCLC not amenable to surgery and candidate for chemoradiotherapy. Preliminary studies in head and neck cancers have demonstrated the feasibility and support the medical benefit of this novel approach. The aim of the study is to assess the efficacy and safety of a radiotherapy dose complement (boost) in this difficult medical condition for which only limited treatment options are available.

Conditions

Stage III Non-small-cell Lung Cancer

Keywords

Radiotherapy; Fmiso; FDG PETSCAN; FMISO PETSCAN; complement dose; lung cancer; NSCLC; hypoxic lesion

Outcome Measures

Primary Outcomes (1)

• Evaluate the rate of local control

  to evaluate the rate of local control after dose complement in hypoxic lesions \[maximum dose without the fraction of total lung volume receiving more that 20 Gy exceeding 30% of the lung (V20)\], as determined by F-miso PET/CT.

  3 month

Secondary Outcomes (4)

• 3 months and 1 year toxicity

  1 year

• Percentage of patients for whom the RT dose could be increased

  3 years

• Simultaneous variation of the glucose metabolism and hypoxia during radiotherapy

  3 years

• Predictive value on 1-year survival

  1 year

Interventions

Radiotherapy RADIATION

No additional dose (patients negative F-miso) * Radiation therapy is conducted under standard conditions of conformal radiotherapy: * The total dose was 66-70 Gy delivered in daily fractions of 2 Gy, 5 days a-week With additional dose (patients positive for F-miso) The dose in the PTVmiso increased until the maximum tolerable radiation by the lung.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with stage III non-small-cell lung cancer candidate for curative radio-chemotherapy

You may not qualify if:

• Other cancer
• no evaluable tumor target
• Absence of binding to FDG-PET tests before primary chemotherapy
• Patients for which radiotherapy with curative intent is not indicated
• History of neoplastic disease of less than 5 years or progressive
• Patient already included in another clinical trial
• Pregnant, likely to be or during breastfeeding
• performance index OMS ≥2
• Indicating renal insufficiency against Cisplatin treatment
• Protected adults
• Unable to submit to medical study for reasons geographical, social or physical
• Patients with poorly controlled diabetes blood sugar ≥10 mmol/L
• hypersensitivity to FDG or any excipients of the radiopharmaceutical
• hypersensitivity to Fmiso or any excipients of the radiopharmaceutical
• Patients unable to understand the study (language ...)

Sponsors & Collaborators

• Centre Henri Becquerel: lead

Study Sites (1)

Centre Henri Becquerel

Rouen, 76000, France

Location

Related Publications (3)

• Ganem J, Thureau S, Gardin I, Modzelewski R, Hapdey S, Vera P. Delineation of lung cancer with FDG PET/CT during radiation therapy. Radiat Oncol. 2018 Nov 12;13(1):219. doi: 10.1186/s13014-018-1163-2.

  PMID: 30419929 DERIVED

• Thureau S, Dubray B, Modzelewski R, Bohn P, Hapdey S, Vincent S, Anger E, Gensanne D, Pirault N, Pierrick G, Vera P. FDG and FMISO PET-guided dose escalation with intensity-modulated radiotherapy in lung cancer. Radiat Oncol. 2018 Oct 23;13(1):208. doi: 10.1186/s13014-018-1147-2.

  PMID: 30352608 DERIVED

• Vera P, Thureau S, Chaumet-Riffaud P, Modzelewski R, Bohn P, Vermandel M, Hapdey S, Pallardy A, Mahe MA, Lacombe M, Boisselier P, Guillemard S, Olivier P, Beckendorf V, Salem N, Charrier N, Chajon E, Devillers A, Aide N, Danhier S, Denis F, Muratet JP, Martin E, Riedinger AB, Kolesnikov-Gauthier H, Dansin E, Massabeau C, Courbon F, Farcy Jacquet MP, Kotzki PO, Houzard C, Mornex F, Vervueren L, Paumier A, Fernandez P, Salaun M, Dubray B. Phase II Study of a Radiotherapy Total Dose Increase in Hypoxic Lesions Identified by 18F-Misonidazole PET/CT in Patients with Non-Small Cell Lung Carcinoma (RTEP5 Study). J Nucl Med. 2017 Jul;58(7):1045-1053. doi: 10.2967/jnumed.116.188367. Epub 2017 Mar 2.

  PMID: 28254869 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2012
• First Posted: April 12, 2012
• Study Start: March 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: June 1, 2017
• Last Updated: July 28, 2016

Record last verified: 2016-07

Locations

FR (1)