FAQ(English)

  • Q

    [SABR] When should SABR be performed in Arm 2 patients?

    A

    • In principle, SABR is performed after the completion of standard salvage treatment, but SABR can be performed even before standard salvage treatment according to the reseacher's discretion.

    • If standard salvage treatment for recurrence is completed within 60 days before registration, only SABR can be performed and follow-up is possible. (※ Refer to p.18 of the protocol)

    • If SABR is performed after cytotoxic chemotherapy, it is recommended to perform it at least 2 weeks afterwards. (※ Refer to p.28 of the protocol)​
  • Q

    [SABR] In case of Arm 2 subject who need to receive another SABR for the lesion that overlap with the previous SABR field, how long the treatment interval should be between these two SABRs?

    A

    In this case, there are several things to consider.

    The probability of tumor control and complicaiton with this treatment may be influenced by total dose and fractional dose used at the previous treatment, how much the treatment area overlaps, how large the current treatment area is, and how close it is to surrounding normal organs. 

    Generally, an interval of at least 6 months is recommended.
  • Q

    [SABR] In case of Arm 2 subject who need to receive another SABR for the lesion that does not overlap with the previous SABR field, how long the treatment interval should be between these two SABRs?

    A

     If the two fields do not overlap, you can proceed with SABR.
  • Q

    [SABR] Is SABR treatment possible for subjects registered in Arm 1?

    A

    In Arm 1, SABR is prohibited. 

    However, radiation therapy is only allowed to advanced lesions that cause symptoms such as bleeding, neurological deficits, pain, intestinal obstruction, and respiratory difficulties. 

    Preventive treatment of asymptomatic metastatic sites without imminent risk is not permitted (violation).

    (※ Refer to p.28 of the protocol)​ 
  • Q

    [Registration] When should I enroll the patient regarding the timing of systemic chemotherapy?

    A

    Enrolling patient is possible at any time after recurrence is confirmed. 

    In other words, you can do immediate after diagnosis of recurrence or completion of standard salvage treatment. 
  • Q

    [Eligibility criteria] Regarding exclusion criterion 3.4 ‘if you have previously received radiation therapy’, are subjects who received radiation therapy in areas other than the current recurrence area also subject to the exclusion criteria?

    A

    It is okay to treat multiple areas after registration, but those with a history of previous radiotherapy belong to in the exclusion criteria. 
  • Q

    [Eligibility criteria] Selection criteria 2.3 ‘Number of permitted metastatic sites: 10 or less However, in relation to 'multiple lesions within a defined anatomical region can be included within one radiation treatment plan and counted as one', is this different from the actual metastatic site?

    A

    Target lesions and nontarget lesions do not distinguish between targets to be treated and those not, but target lesions and nontarget lesions are determined (according to size, etc.) based on RECIST 1.1. 

    A lesion that is subject to radiation therapy does not mean that it is a target lesion or that it is a nontarget lesion. 

    In study plan 2.3, the phrase “multiple lesions in an anatomical region can be included in one radiotherapy plan and counted as one lesion” is used only when evaluating whether the selection criteria are met.