Subsection 1: General provisions

The cancer treatment activity mentioned in 18° of article R. 6122-25 consists of treating malignant solid tumours or haematological malignancies. This treatment is medical, surgical, or carried out by external radiotherapy or brachytherapy.

Authorisation for a cancer treatment activity is granted for one or more of the following procedures: 1° Oncological surgery; 2° External radiotherapy, brachytherapy; 3° Systemic medicinal treatments for cancer.

Oncological surgery is a curative treatment of a cancerous tumour carried out in an interventional sector. It includes conservative surgery, lymph node dissection, radical surgery, macroscopically complete tumour resection in the case of peritoneal carcinosis, surgery to treat metastases, non-percutaneous tumour destruction techniques, immediate reconstruction surgery performed at the same time as the resection, and recurrence surgery.

The “Oncological surgery” modality comprises the following entries: I.-Category A providing oncology surgery in adults for one or more of the following seven tumour locations, mentioned in the authorisation, and excluding complex surgery mentioned in category B: 1° A1: Visceral and digestive oncology surgery; 2° A2: Thoracic oncology surgery; 3° A3: Otorhinolaryngeal, cervicofacial and maxillofacial oncological surgery, including thyroid cancer surgery; 4° A4 : Urological oncological surgery; 5° A5 :…

External radiotherapy is a cancer treatment method that uses ionising radiation to destroy cancer cells using rays produced by a linear particle accelerator, while sparing peripheral healthy tissue as much as possible with the aid of an imaging device. Brachytherapy is a radiotherapy technique in which sealed radioactive sources are implanted inside the body of a cancer patient, either directly into the tumour or in contact with it.

The “External radiotherapy, brachytherapy” modality comprises the following entries: 1° Entry A providing external radiotherapy treatment for adults; 2° Entry B providing brachytherapy treatment for adults; 3° Option C providing the same treatments for children and adolescents under the age of eighteen, in addition to external radiotherapy or brachytherapy treatments for adults.

Systemic drug treatments for cancer include chemotherapy, targeted therapies, immunotherapy and advanced therapy drugs, whatever the route of administration.

The “Systemic drug treatments for cancer” modality comprises the following entries: 1° Entry A providing systemic drug treatments for cancer in adults, excluding intensive chemotherapy mentioned in entry B; 2° Entry B providing, in addition to systemic drug treatments for cancer in adults, intensive chemotherapy leading to foreseeable aplasia of more than eight days and the management of this foreseeable aplasia; 3° Mention C providing systemic medicinal treatments for cancer…

Establishments are not subject to authorisation for cancer treatment when they provide: 1° Surgery to diagnose cancer; 2° For patients with an established cancer diagnosis, surgery to treat or alleviate a complication linked to the consequences of cancer or its treatment, without attempting to remove the tumour; 3° An emergency operation for another indication, leading to the discovery of a malignant tumour. The operation is then carried out without attempting…

I.- Authorisation holders for medicine, surgery, interventional radiology, medical care and rehabilitation or home hospitalisation may be associated with an authorisation holder for cancer treatment using systemic medicinal treatments. II.-Within the framework of a formalised organisation with this authorisation holder, and without being subject to the cancer treatment authorisation, these establishments may: 1° Apply systemic cancer drug treatments decided upon and first prescribed by the authorisation holder for systemic cancer…