• Q

    When is the timing for measuring lymphatic-related complications?


    è  As per Protocol section 7.4 'Timing of Measurement for Lymphatic-Related Complications', the assessment timings include: at the time of screening, within 30 days after lymph node dissection (applicable to the experimental group only), at 3 months after completion of CCRT treatment, and once a year when the participant reports symptoms of lymphatic-related complications.

  • Q

    Until how many weeks can the administration of the anticancer agent be postponed in case of adverse reactions?


    è  The administration of the anticancer agent can be delayed for a maximum of 2 weeks, and if the delay exceeds 3 weeks, consideration should be given to adjusting the cisplatin dosage. Chemotherapy can be initiated if the following criteria are satisfied. If any of these criteria are not met, the administration of the anticancer agent should be postponed.


    Within 7 days prior to anticancer agent administration - Hematological findings.

     [1] Neutrophil: 1,000/mm³, Grade 2 or higher

     [2] Platelet count: ≥75,000/mm³, Grade 1 or higher

     [3] SGOT: 100 U/L

     [4] SGPT: 100 U/L

     [5] Total bilirubin: ≤2.0 mg/dL

     [6] Creatinine: ≤1.2 mg/dL

     (However, for the first cycle of chemotherapy, results up to within 4 weeks can be utilized.)


    One day prior to chemotherapy drug administration.

     [1] No peripheral motor or sensory neuropathy of Grade 2 or higher.

     [2] No auditory impairment of grade 2 or higher

     [3] No diarrhea of grade 3 or higher.

     [4] No nausea or vomiting or loss of appetite of grade 3 or higher.

     [5] No fever due to infection exceeding 38

     [6] No non-hematologic toxicity of grade 3 or higher related to treatment.


  • Q

    When should cisplatin chemotherapy for cancer be initiated?


    è  According to protocol 5.6.2, regarding the guidelines for the initiation and dosage adjustment of chemotherapy, cisplatin should be commenced within 7 days before or after radiation therapy. It should be administered at a dosage of 40mg/m2 (maximum 70mg) every 1 week for 5-6 cycles. The 6th cycle may be omitted based on the investigator's discretion.

  • Q

    If the radiation therapy dose given to the participant differs from the dose recommended by the Debulk study protocol and is administered at a different level, should the participant be excluded from this study, or is it permissible to document an infringement report and continue with the study?


    è  If a different dosage is prescribed, it constitutes a protocol violation; however, it doesn't necessarily mandate an immediate dropout from the study.