Treatment of Opioid-refractory Pain (WHO Level III) by Pituitary Radiosurgery

NCT ID: NCT02637479

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2025-12-31

Brief Summary

80% of palliative care cancer patients suffer from severe pain. The management of these pain improves the quality of life of these patients. The management of opioid pain refractory to date remains a difficulty for caregivers. Hypophysectomy performed to try to control hormone-dependent neoplasia also help relieve pain associated with lesions secondary cancer. The surgical hypophysialis radio Gamma Knife ® was recently performed on a small number of patients. She would have the advantage of reducing the risk of complications compared to other techniques and achieve similar analgesic effect on diffuse, or mixed nociceptive pain associated with metastases on average in 2 days and would reduce or stop opiates most often responsible for side effects impairing the quality of life. The objective of this clinical trial, multicenter, prospective, randomized controlled is to evaluate the effectiveness of surgical hypophysialis radio for patients in palliative situations with refractory cancer pain in opioid level III. The type of pain "cancer pain" was done in order to optimize the recruitment and homogenization of the study population: patients cared for in palliative care units are mostly patients cancer (70-80%). This study is therefore part of a palliative setting and the results of this test can be extrapolated to other populations of palliative patients with refractory pain.

Conditions

Any Cancer With Multiple Bone Metastases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pituitary radiosurgery group

Subjects will receive a pituitary radiosurgery by GammaKnife® during a brief hospitalization associated with standards of care for pain according to recommendations (Standards, Options and Recommendations about drug analgesic treatments for nociceptive cancer pain in adults)

Group Type: EXPERIMENTAL

GammaKnife®

Intervention Type: DEVICE

18F-2-fluoro-2-deoxy-D-glucose - positron emission tomography (FDG-PET)

Intervention Type: DEVICE

MRI

Intervention Type: DEVICE

Control group

Subject will receive standards of care for pain according to recommendations (Standards, Options and Recommendations about drug analgesic treatments for nociceptive cancer pain in adults)

Group Type: ACTIVE_COMPARATOR

18F-2-fluoro-2-deoxy-D-glucose - positron emission tomography (FDG-PET)

Intervention Type: DEVICE

Interventions

GammaKnife®

Intervention Type: DEVICE

18F-2-fluoro-2-deoxy-D-glucose - positron emission tomography (FDG-PET)

Intervention Type: DEVICE

MRI

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Man or woman, aged 18 years or older;
• Subject suffering from nociceptive or mixed pain, not related to acts, refractory to standard opioid therapy
• Subject having a cancer defined by histology whatever the origin of the primitive cancer,
• Subject having multiple bone metastases
• Subject in palliative care state according to the definition given by the French Society of Palliative Care and Support
• Subject supported by structures of palliative care, pain or cancer involved in the study
• Inpatient and outpatient
• Subject without a curative cancer treatment and with or without palliative anticancer treatment;
• Subject non in "ultimate" phase (estimated survival superior at 48 h by a physician)
• Subject with acceptable general condition (Karnofsky performance Status Scale superior at 40
• Subject with a preserved vigilance defined from the Epworth scale
• Subject with preserved cognition according to the scale Basic Test Concentration, Memory and Guidance (TELECOM)
• Subject which can fill in a questionnaire, able to read or to understand the French language;
• Subject who signed an informed consent;
• Subject affiliated to the French health insurance system.

Exclusion Criteria

• Subject with a curative cancer treatment
• Subject in "ultimate" phase (estimated by the physician of survival less than 48 hours)
• History of whole brain radiation
• History of radiosurgery of pituitary lodge
• Subject treated there less than a month by external or metabolic radiotherapy analgesic, surgical analgesic technic
• Subject minor, pregnant or breastfeeding, subject not being affiliated to the French health insurance system or private about freedom;
• Subject refusing to participate in the study or not signing the informed consent.
• Subject allergic to any component of Fludeoxyglucose (18F)
• Subject allergic to gadolinium salts.
• Subject with severe renal impairment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Assistance Publique Hôpitaux de Marseille

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

DESALBRES Urielle, Director

Role: CONTACT

drci@ap-hm.fr

0491382747

DHORNE Jean, Manager

Role: CONTACT

jean.dhorne@ap-hm.fr

0491381475

Facility Contacts

DESALBRES Urielle, Director

Role: primary

drci@ap-hm.fr

0491382747

Other Identifiers

2015-A00616-43

Identifier Type: REGISTRY

Identifier Source: secondary_id

RCAPHM15_0022

Identifier Type: OTHER

Identifier Source: secondary_id

2014-51

Identifier Type: -

Identifier Source: org_study_id