Study protocol: randomized phase III trial of neo-adjuvant and adjuvant chemotherapy vs. immediate surgery and adjuvant chemotherapy for localized soft tissue sarcoma: Japan Clinical Oncology Group study JCOG2102 (NACLESS)
The optimal timing of surgery and the number of courses of perioperative chemotherapy for high-risk soft tissue sarcoma patients are still controversial. Tumour growth during neoadjuvant chemotherapy led to limb amputation in some patients. This study aims to confirm the non-inferiority of surgery and three courses of adjuvant chemotherapy with adriamycin (30 mg/m2, days 1 and 2) plus ifosfamide (2 g/m2, days 1-5) compared with our standard treatment of three courses of neoadjuvant chemotherapy and surgery followed by two courses of adjuvant chemotherapy with adriamycin plus ifosfamide for localized high-risk soft tissue sarcoma patients. This is a multi-center, two-arm, open-label, randomized phase III trial. The primary aim is to confirm the non-inferiority in overall survival (margin: hazard ratio of 1.61). This is the first randomized controlled trial to compare neoadjuvant chemotherapy and immediate surgery for soft tissue sarcoma. This trial was initiated on 16 November 2022 and registered with the Japan Clinical Trials Registry (jRCTs031220446).
Authors
- Kazutaka Kikuta (ORCID: https://orcid.org/0000-0001-8054-9738)
- Toshifumi Ozaki (ORCID: https://orcid.org/0000-0003-1732-9307)
- Y. Sano (ORCID: https://orcid.org/0000-0001-7753-8712)
- Yuki Funauchi (ORCID: https://orcid.org/0000-0001-7031-672X)
- Toshiyuki Kunisada (ORCID: https://orcid.org/0000-0002-1775-850X)
- Akihito Nagano (ORCID: https://orcid.org/0000-0003-0261-480X)
- Kazuhiro Tanaka (ORCID: https://orcid.org/0000-0002-5138-8952)
- Satoshi Tsukushi (ORCID: https://orcid.org/0000-0002-2181-0702)
- Haruhiko Fukuda (ORCID: https://orcid.org/0000-0002-6332-4745)
- Koji Hiraoka (ORCID: https://orcid.org/0009-0008-0401-9960)
- Makoto Endo (ORCID: https://orcid.org/0000-0002-7956-2190)
- Yoshinao Oda (ORCID: https://orcid.org/0000-0001-9636-1182)
- Hiroaki Hiraga (ORCID: https://orcid.org/0000-0003-1825-1070)
- Tsukasa Yonemoto (ORCID: https://orcid.org/0000-0002-5390-7496)
- Tetsuya Sekita (ORCID: https://orcid.org/0000-0002-4000-6891)
- Ryunosuke Machida (ORCID: https://orcid.org/0000-0002-3734-6203)
- Akio Sakamoto (ORCID: https://orcid.org/0000-0002-7518-1606)
- Akira Kawai (ORCID: https://orcid.org/0000-0002-1040-3706)
- Keisuke Ae
Institutions
- Kurume University (JP)
- Tokyo Medical and Dental University (JP)
- Kyushu University (JP)
- Okayama University (JP)
- Oita University (JP)
- Kyoto University (JP)
- Cancer Institute (WIA) (IN)
- Fukuoka University (JP)
- National Cancer Center (US)
- National Hospital Organization Hokkaido Medical Center (JP)
- Chiba Cancer Center (JP)
- Tochigi Cancer Center (JP)
- Aichi Cancer Center (JP)
- Japan Clinical Cancer Research Organization (JP)
- Sapporo National Hospital (JP)
- Gifu University (JP)
- Japanese Foundation For Cancer Research (JP)
- The University of Tokyo (JP)
Publication Details
- Journal
- Japanese Journal of Clinical Oncology
- Published
- 2024-11-05
- DOI
- https://doi.org/10.1093/jjco/hyae160
- Citations
- 2
- Primary Topic
- Sarcoma Diagnosis and Treatment
- Type
- article
- Field-Weighted Citation Impact
- 0.84
Funders
- Teikyo University School of Medicine
- Keio University
- University of Fukui