Table of Contents
- Trial overview
- Ovarian cancer studies
- Kidney protection study
- Calcinosis cutis study
- Hearing loss prevention study
- Pediatric liver cancer study
- Main endpoints and what they mean
Trial overview
Several interventional studies are testing Sodium Thiosulfate in different patient groups.[1][2][3][4][5][6] The studies include both Phase 2 and Phase 3 trials, and most are already authorised.[1][2][3][4][5][6]
The research questions are different across trials: some studies test whether Sodium Thiosulfate improves survival in cancer, while others test whether it helps prevent kidney damage, hearing loss, or skin lesion progression.[1][2][3][4][5][6]
Ovarian cancer studies
Two Phase 3 trials are studying Sodium Thiosulfate in ovarian cancer settings.[1][2] One trial includes epithelial ovarian cancer, fallopian tube ovarian cancer, and peritoneal ovarian cancer, and it compares standard surgery care with or without HIPEC, which means heated chemotherapy given inside the abdomen during surgery.[1]
That study measures disease-free survival, which is the time after randomization until the disease comes back, gets worse, or the patient dies from any cause.[1] The trial includes 352 people and is authorised.[1]
The second ovarian cancer trial is OVHIPEC-2, which studies FIGO stage III ovarian cancer in people who are eligible for primary cytoreductive surgery, meaning surgery aimed at removing as much visible cancer as possible.[2] This study looks at whether adding HIPEC changes overall survival, which is the time from randomization until death from any cause.[2]
OVHIPEC-2 includes 538 participants and is also authorised.[2] Sodium Thiosulfate is listed among the study drugs in this trial.[2]
Kidney protection study
One Phase 2 trial compares cilastatin with Sodium Thiosulfate for renal protection in patients having debulking surgery with intraoperative HIPEC using cisplatin.[3] The study is focused on acute kidney injury, which means sudden kidney damage after treatment or surgery.[3]
The main endpoint is the percentage of patients with renal failure at 7 days, with follow-up up to postoperative day 14 if kidney damage occurs.[3] Kidney failure is measured using creatinine values, urine output, and the KDIGO classification, which is a standard system for grading kidney injury.[3]
This study includes 90 participants and is authorised.[3] It is designed as a non-inferiority study, meaning it tests whether one option is not worse than the other by more than a set amount.[3]
Calcinosis cutis study
One Phase 3 randomized study is looking at intralesional Sodium Thiosulfate in people with calcinosis cutis in systemic sclerosis.[4] Calcinosis cutis means calcium deposits in the skin or soft tissue.[4]
The study aims to find out whether treatment can lead to complete or partial remission of calcinosis lesions between week 0 and week 28.[4] Complete remission is defined as removal of total calcinosis volume on scans and/or full clinical clearance, while partial remission means some reduction in calcinosis or improvement in patient-reported assessment.[4]
The trial includes 75 participants and is described as prospective, multi-centre, and investigator-initiated.[4] It also evaluates safety, according to the brief summary.[4]
Hearing loss prevention study
The SOUND trial is a Phase 3 randomized multicenter study testing transtympanic Sodium Thiosulfate in people with head and neck squamous cell carcinoma.[5] Transtympanic injection means the treatment is given through the eardrum into the middle ear.[5]
This study is looking at whether Sodium Thiosulfate can reduce cisplatin-related hearing loss, also called platinum-related ototoxicity.[5] The main outcome is the percent of patients with a clinically relevant benefit, defined by hearing threshold changes at 3 months after treatment.[5]
The trial includes 100 participants and is authorised.[5]
Pediatric liver cancer study
Another Phase 3 trial is studying children and adolescents with primary malignant liver cancer, including hepatoblastoma and hepatocarcinoma.[6] Sodium Thiosulfate appears in the intervention list under the brand name Pedmark.[6]
This study is broad and looks at several outcomes depending on the study group, including event-free survival, overall survival, adherence to surgical guidelines, chemotherapy-related toxicity, hearing loss, response, failure-free survival, and surgical resectability.[6] Surgical resectability means whether the tumor can be removed by surgery.[6]
The trial includes 60 participants and is authorised.[6] It is designed to help individualize treatment and possibly reduce side effects without lowering cure rates.[6]
Main endpoints and what they mean
Across these trials, the main endpoints are survival, disease control, kidney safety, hearing outcomes, and lesion remission.[1][2][3][4][5][6] Endpoints are the main results researchers plan to measure to judge whether a treatment works.[1][2][3][4][5][6]
In the ovarian cancer studies, the most important endpoints are disease-free survival and overall survival.[1][2] In the kidney study, the endpoint is renal failure within the first 7 days, with longer follow-up if needed.[3]
In the calcinosis cutis study, the endpoint is complete or partial remission of calcinosis lesions over 28 weeks.[4] In the hearing loss study, the endpoint is a clinically relevant hearing benefit measured by hearing threshold changes.[5] In the pediatric liver cancer study, the endpoints are broader and include survival, toxicity, and surgery-related outcomes.[6]
