Study Assessing Two Models of Hypofractionated Protontherapy on Large Choroidal Melanomas

NCT02602756 | Terminated DMC

• 1 other identifier: 2015/02
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Melanoma

Keywords

Choroid Melanoma

Outcome Measures

Primary Outcomes (1)

• local control rate without severe complications 2 years after.

  up to 60 months

Secondary Outcomes (5)

• Enucleation rate

  up to 60 months

• Tumoral transretinien endoresection by unplanned vitrectomy in inclusion (emergency procedure)

  up to 60 months

• Number of months without metastases evaluation

  up to 60 months

• Number of months of Specific global survival evaluation

  up to 60 months

• Complications and toxicity evaluation (number of subjects with adverse events related to treatment)

  up to 60 months

Study Arms (2)

A

ACTIVE COMPARATOR

Protontherapy : 4 sessions of 13 Gy, total dosis 52 Gy

Radiation: Protontherapy

B

EXPERIMENTAL

Protontherapy : 8 sessions of 6.5 Gy, total dosis 52 Gy

Radiation: Protontherapy

Interventions

Protontherapy RADIATION

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).

A; B

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead

Study Sites (1)

Centre Antoine Lacassagne

Nice, 06000, France

Location

Related Links

• Related Info

MeSH Terms

Conditions

Melanoma; Uveal Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Uveal Neoplasms; Eye Neoplasms; Eye Diseases; Uveal Diseases

Study Officials

• Juliette THARIAT, md

  Centre Antoine Lacassagne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study with 2 differents dosages of proton therapy

Study Record Dates

• First Submitted: November 9, 2015
• First Posted: November 11, 2015
• Study Start: November 2, 2015
• Primary Completion: September 1, 2018
• Study Completion: November 30, 2022
• Last Updated: December 14, 2022

Record last verified: 2022-12

Locations

FR (1)