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Study Assessing Two Models of Hypofractionated Protontherapy on Large Choroidal Melanomas (HYGROMEL)

This study is currently recruiting participants.
Verified June 2016 by Centre Antoine Lacassagne
Sponsor:
ClinicalTrials.gov Identifier:
NCT02602756
First Posted: November 11, 2015
Last Update Posted: July 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Antoine Lacassagne
  Purpose

Ocular melanomas have been treated for a long time by enucleation, with an unfavorable major impact on the patient's quality of life, social life, self-image, how they feel about others and about living with this disability. As a matter of fact, classical radiation therapy by photons is not accurate enough to deliver a sufficiently high dose to eradicate a melanoma without causing irreversible ocular brain complications since these tumors are " relatively radio resistant ". The possibility of delivering high doses due to the precision of protons ("Bragg peak") has allowed to overcome this limitation. The conservative uveal melanoma treatment has become a standard after the Collaborative Ocular Melanoma Study (COMS) indicating an equivalent rate of metastases and a non-impaired survival rate with a conservative treatment when compared to immediate enucleation. The quality of life benefits due to a conservative treatment has been demonstrated. Protontherapy dose has been defined in an empirical manner, it is probably excessive even if it applies to radio-resistant tumors. In France, radiotherapy by protons for choroidal melanomas delivers a dose of 60 Gy cobalt equivalent (that is 52 measured Gy, or " Physical dose") in 4 fractions and 4 days.

Referential treatment of ocular melanomas (other than conjunctiva) indicates proton-therapy for T1, T2, T3 < 40% of ocular volume, and T4 only if extra scleral extension ≤ 2mm. However, there is an enucleation indication for T3 > 40% of ocular volume and T4.

Our purpose is to override this relative contraindication, choroidal melanoma volume ≥ 40% of ocular volume. As a matter of fact, the investigators observe an increasing demand from ophthalmologists and patients for not performing primary enucleation. Also, during the last five years treatment of complications have improved and a less " hard " hypo fractionation (6.5 Gy per fraction) has equivalent local control results as for " hard " fractionation (13 Gy per fraction).


Condition Intervention Phase
Melanoma Radiation: Protontherapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Phase II Trial, Randomized, Under Single-blind Conditions, Assessing Two Models of Modified Hypofractionated Proton-therapy on Patients With Large Choroidal Melanomas

Resource links provided by NLM:


Further study details as provided by Centre Antoine Lacassagne:

Primary Outcome Measures:
  • local control rate without severe complications 2 years after. [ Time Frame: up to 60 months ]

Secondary Outcome Measures:
  • Enucleation rate [ Time Frame: up to 60 months ]
  • Tumoral transretinien endoresection by unplanned vitrectomy in inclusion (emergency procedure) [ Time Frame: up to 60 months ]
  • Number of months without metastases evaluation [ Time Frame: up to 60 months ]
  • Number of months of Specific global survival evaluation [ Time Frame: up to 60 months ]
  • Complications and toxicity evaluation (number of subjects with adverse events related to treatment) [ Time Frame: up to 60 months ]

Estimated Enrollment: 82
Study Start Date: November 2015
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Protontherapy : 4 sessions of 13 Gy, total dosis 52 Gy
Radiation: Protontherapy
Proton-therapy consists in four consecutive sessions. The experimental arm consists in eight sessions. Irradiation is administered over two weeks, delivering a total dose of 60 Cobalt Gris Equivalent (CGE is the physical Gray dose multiplied by a biological factor of relative efficiency of 1.1 for protons compared to photons).
Experimental: B
Protontherapy : 8 sessions of 6.5 Gy, total dosis 52 Gy
Radiation: Protontherapy
Proton-therapy consists in four consecutive sessions. The experimental arm consists in eight sessions. Irradiation is administered over two weeks, delivering a total dose of 60 Cobalt Gris Equivalent (CGE is the physical Gray dose multiplied by a biological factor of relative efficiency of 1.1 for protons compared to photons).

Detailed Description:

A more fractioned proton-therapy treatment, with doses per fraction of 6.5 Gy rather than 13 Gy, can limit the rate and the severity of complications degrading the quality of life by complications (pain, diminished visual acuity) and treatments (intra-ocular injections...).

In this study, patients will receive a total dose of 52 Gy in four 13 Gy sessions for the standard arm and in eight 6.5 Gy sessions for the experimental arm.

The investigators expect an identical local control rate within 2 year's time with a decrease in rate and severity of severe complications due to adapted fractionation (eight sessions with lower doses instead of four fractions with very high doses as it is usually recommended in the guidelines for small to medium melanomas).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient diagnosed with choroidal melanoma by an ophthalmologist and proton-therapy treatment proposed by the multi-disciplinary board meeting
  • Patient over 18 years old, male or female
  • Performance status ≤ 2
  • Size and/or thickness greater than those proposed on proton-therapy appendix indications (tumor volume/ocular globe > 40% and/or thickness ≥ 12 mm and/or diameter ≥ 18 mm or thickness ≥ 10 mm and diameter ≥ 15 mm). Possible ophthalmological follow-up examinations at 6 months, one year, 18 months and two years.
  • No contraindication for adjuvant chemotherapy
  • Authorized technique to preserve the optic nerve
  • Patient having undergone the required medical procedures:

    • Ophthalmological examination
    • Clip positioning
    • Proton-therapy treatment (localization CT, first simulation, second simulation, final simulation)
  • Patient reads information note and signs consent form

Exclusion Criteria:

  • Exclusive iris damage
  • Exclusive conjunctival damage
  • First melanoma surgery
  • Enucleation planned post-proton-therapy
  • Exentration indication
  • Life expectancy < 2 years
  • Scleral exteriorisation > 2 mm
  • Absolute radiotherapy contraindication (ataxia-telangiectasia)
  • Cancer history, except for complete remission cancers of over 5 years, basocellular skin carcinomas completely resected, in-situ carcinomas or treated in situ cervical epithelioma
  • Presence of metastases other than hepatic (endoresection authorized)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602756


Contacts
Contact: Juliette THARIAT, Md +33492031618 juliette.thariat@nice.unicancer.fr
Contact: Christine LOVERA +33492031618 christine.lovera@nice.unicancer.fr

Locations
France
Centre Antoine Lacassagne Recruiting
Nice, France, 06000
Contact: Juliette THARIAT, md    +33492031618    juliette.thariat@nice.unicancer.fr   
Contact: Christine LOVERA    +33492031618    christine.lovera@nice.unicancer.fr   
Sponsors and Collaborators
Centre Antoine Lacassagne
Investigators
Principal Investigator: Juliette THARIAT, md Centre Antoine Lacassagne
  More Information

Additional Information:
Responsible Party: Centre Antoine Lacassagne
ClinicalTrials.gov Identifier: NCT02602756     History of Changes
Other Study ID Numbers: 2015/02
First Submitted: November 9, 2015
First Posted: November 11, 2015
Last Update Posted: July 26, 2016
Last Verified: June 2016

Keywords provided by Centre Antoine Lacassagne:
Choroid Melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas