Folic acid for Metastatic renal cell carcinoma

Inclusion criteria

• {"criterion_text":"- 1. Patients displaying CTCAE ≥2 mucositis during TKI or mTOR inhibitor or IT treatment.\n- 2. Signed written informed consent obtained prior to any study specific procedures.\n- 3. Patient must be willing and able to comply with the protocol.\n- 4. Age ≥ 18\n- 5. Biopsy proven locally advanced or metastatic renal cell carcinoma.\n- 6. Females with a negative serum pregnancy test unless childbearing potential can be otherwise excluded (postmenopausal, hysterectomy or oophorectomy) and not lactating.\n- 7. Fertile women of childbearing potential (<2 years after last menstruation) and men must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgical sterilization).\n- 8. Karnofsky Performance status ≥ 60%."}

Exclusion criteria

• {"criterion_text":"- Known hypersensitivity to folic acid.\n- Use of prednisolone more than 10 mg daily."}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the degree of CTCAE mucositis (nasal, oral, pharyngeal, anal, or genital) according to the Common Terminology Criteria for Adverse Events v. 4.0 (CTCAE).","definition_or_measurement_approach":"Measured as degree of mucositis according to Common Terminology Criteria for Adverse Events v.4.0 (CTCAE)."}

Secondary endpoints

• {"endpoint_text":"- The frequency and degree of mucositis (nasal, oral, pharyngeal, anal, or genital) according to patient-reported outcomes (PRO) by self assessment questionnaire using National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (NCCN-FACT FKSI-19) and a modified version of the M.D. Anderson Symptom Inventory (MDASI) for RCC.","definition_or_measurement_approach":"Patient-reported outcomes (PRO) via NCCN-FACT FKSI-19 and modified MDASI for RCC; frequency and degree assessed by these questionnaires."}
• {"endpoint_text":"- The median time to effect of study drug according to CTCAE 4.0 and PRO.","definition_or_measurement_approach":"Time-to-effect measured per CTCAE v4.0 grading and PRO assessments."}
• {"endpoint_text":"- The frequency of TKI/mTOR dose reductions in the two groups","definition_or_measurement_approach":"Frequency of dose reductions of concomitant TKI/mTOR therapies recorded and compared between groups."}
• {"endpoint_text":"- The frequency of TKI/mTOR/IT treatment discontinuations in the two groups","definition_or_measurement_approach":"Frequency of discontinuations of TKI/mTOR/immune therapy treatments recorded and compared."}
• {"endpoint_text":"- The frequency of TKI/mTOR/IT treatment withdrawals in the two groups","definition_or_measurement_approach":"Frequency of treatment withdrawals of TKI/mTOR/immune therapy recorded and compared."}
• {"endpoint_text":"- The frequency and degree of GI adverse events in the two groups according to CTCAE v. 4.0 and PRO.","definition_or_measurement_approach":"Gastrointestinal adverse events graded by CTCAE v4.0 and assessed by PRO instruments."}
• {"endpoint_text":"- The frequency and degree of hand-foot syndrome in the two groups according to CTCAE v. 4.0 and PRO.","definition_or_measurement_approach":"Hand-foot syndrome graded by CTCAE v4.0 and assessed by PRO."}
• {"endpoint_text":"- The quality of life in the two groups according to NCCN-FACT FKSI-19 and the M.D. Anderson Symptom Inventory for RCC.","definition_or_measurement_approach":"Quality of life measured by NCCN-FACT FKSI-19 and MDASI for RCC instruments."}

Denmark

Earliest CTIS Part Ii Submission Date

28-08-2024

Latest Decision Or Authorization Date

10-09-2024

Processing Time Days

13

Number Of Sites

2

Number Of Participants

100

Primary sponsor

Full Name

Region Midtjylland

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Educational Institution"}