Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000124
Status:
UNKNOWN
Last Update Posted:
2006-06-02
First Post:
1999-09-23
Brief Title:
Collaborative Ocular Melanoma Study COMS
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2002-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate therapeutic interventions for patients who have choroidal melanoma the most common primary eye cancer affecting adults and to assess the potential life-preserving as well as sight-preserving role of radiation therapy
To determine which of two standard treatments removal of the eye or brachytherapy is more likely to prolong survival of eligible patients with medium-sized choroidal melanoma
To determine whether preoperative radiation prolongs life for patients whose eyes with large choroidal melanoma are enucleated
To determine which of two standard treatments removal of the eye or brachytherapy is more likely to prolong survival of eligible patients with medium-sized choroidal melanoma
To determine whether preoperative radiation prolongs life for patients whose eyes with large choroidal melanoma are enucleated
Detailed Description:
For more than 100 years removal of the eye enucleation has been the standard treatment for choroidal melanoma Before the COMS was initiated in 1986 interest in radiation therapy had increased because of the potential for saving the eye and perhaps some vision However the merits of radiation with respect to prolonging patient survival were unknown The best data from nonrandomized studies suggested that there was no difference in length of remaining life between patients treated with radiation and those whose eyes were enucleated Thus it was appropriate and necessary to conduct a randomized controlled clinical trial in which a large number of patients would be followed for many years in order to compare enucleation and radiation with respect to relative success in prolonging survival of choroidal melanoma patients
The Collaborative Ocular Melanoma Study COMS is a set of long-term multicenter randomized controlled trials In the trial for patients with tumors of medium size enucleation and irradiation with an iodine-125 episcleral plaque are compared on the basis of length of remaining life All randomized patients will be followed for 5 to 15 years or until death For patients randomly assigned to enucleation the eye was removed following a standard procedure For patients assigned to plaque irradiation the margins of the tumor were located and the dimensions of the tumor were measured by the ophthalmic surgeon A gold plaque with a plastic seed carrier that contained the proper dosage and configuration of radioactive iodine seeds was sutured to the outside sclera of the eye over the base of the tumor This procedure made possible the delivery of a high dose of radiation to a very localized area 85 Gy TG-43 to the tumor apex The plaque typically was removed from the eye after three to seven days Enrollment was completed in this trial in July 1998 with 1317 patients enrolled Clinical follow-up of patients will end in July 2003
In the COMS trial of preoperative radiation patients with large tumors were randomized to enucleation alone or to enucleation preceded by 20 Gy of external beam radiation The two randomly assigned groups of patients were followed for at least five years or until death and have been compared on the basis of length of remaining life and other outcomes Enrollment in this trial was completed in December 1994 with 1003 patients enrolled Clinical follow-up of all patients in this trial ended in July 2000
Accrual to a nonrandomized pilot study to assess the feasibility of a randomized trial for small tumors was halted in 1989 Additional followup of those 204 patients was carried out from 1994 to 1996
The COMS is conducted in 43 clinical centers located in major population areas of the United States and Canada Six resource centers participate and have major roles in quality assurance for the study Information gathered and analyzed includes time to death from all causes time to death from cancer whether metastatic choroidal melanoma or not diagnosis of other tumors complications of radiation and changes in visual acuity A parallel study of quality of life for patients enrolled in the trial of radioactive plaque was initiated in January 1995 From November 1986 through July 1998 8712 patients with choroidal melanoma of all sizes were screened for eligibility for a COMS clinical trial
The Collaborative Ocular Melanoma Study COMS is a set of long-term multicenter randomized controlled trials In the trial for patients with tumors of medium size enucleation and irradiation with an iodine-125 episcleral plaque are compared on the basis of length of remaining life All randomized patients will be followed for 5 to 15 years or until death For patients randomly assigned to enucleation the eye was removed following a standard procedure For patients assigned to plaque irradiation the margins of the tumor were located and the dimensions of the tumor were measured by the ophthalmic surgeon A gold plaque with a plastic seed carrier that contained the proper dosage and configuration of radioactive iodine seeds was sutured to the outside sclera of the eye over the base of the tumor This procedure made possible the delivery of a high dose of radiation to a very localized area 85 Gy TG-43 to the tumor apex The plaque typically was removed from the eye after three to seven days Enrollment was completed in this trial in July 1998 with 1317 patients enrolled Clinical follow-up of patients will end in July 2003
In the COMS trial of preoperative radiation patients with large tumors were randomized to enucleation alone or to enucleation preceded by 20 Gy of external beam radiation The two randomly assigned groups of patients were followed for at least five years or until death and have been compared on the basis of length of remaining life and other outcomes Enrollment in this trial was completed in December 1994 with 1003 patients enrolled Clinical follow-up of all patients in this trial ended in July 2000
Accrual to a nonrandomized pilot study to assess the feasibility of a randomized trial for small tumors was halted in 1989 Additional followup of those 204 patients was carried out from 1994 to 1996
The COMS is conducted in 43 clinical centers located in major population areas of the United States and Canada Six resource centers participate and have major roles in quality assurance for the study Information gathered and analyzed includes time to death from all causes time to death from cancer whether metastatic choroidal melanoma or not diagnosis of other tumors complications of radiation and changes in visual acuity A parallel study of quality of life for patients enrolled in the trial of radioactive plaque was initiated in January 1995 From November 1986 through July 1998 8712 patients with choroidal melanoma of all sizes were screened for eligibility for a COMS clinical trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None