Phase II study of Concurrent Chemoradiotherapy using Nedaplatin for Locally Advanced Uterine Cervical Carcinoma: Kitasato Gynecologic Radiation Oncology Group 0501 (KGROG0501)

Phase II study of Concurrent Chemoradiotherapy using Nedaplatin for Locally Advanced Uterine Cervical Carcinoma: Kitasato Gynecologic Radiation Oncology Group 0501 (KGROG0501) - Phase II study of Concurrent Chemoradiotherapy using Nedaplatin for Locally Advanced Uterine Cervical Carcinoma: KGROG0501

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025688

Enrollment

Registered

2017-01-15

Start date

2005-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Uterine Cervical Carcinoma

Interventions

chemoradiotherapy

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1)pathologically proven squamous cell carcinoma or adenocarcinoma, 2)clinical FIGO stage Ib, IIa, IIb with bulky tumor (40mm and/or more assessed by magnetic resonance imaging) or pelvic lymph node sweelling (10mm and/or more assessed by computed tomography); Clinical FIGO stage IIIa, IIIb or IVa, 3)Age: 20-75 years, 4) Pefomance status (Eastern Cooperative Oncology Group): 0-2, 5)No prior radiatoin therapy for abdomen and pelvis, 6)Adequate functoin of bone marrow, kidney and liver (white blood cell count >= 2500 mm3, neutrophil >= 1000 mm3, hemoglobin >= 8.0g/dl, platelet count >= 75,000 mm3, creatinine <= 2.0 mg/dl, 24h-Ccr >= 60 ml/min, GOT and GPT <= 2 times of the upper limit of normal value at our institution, T.Bil < 2 times of the upper limit of normal at our institution), 7) Written informed consent

Exclusion criteria

Exclusion criteria: 1)Active other cancers except carcinoma in situ or contorolled for more than 2 years, 2)Use of long-term and continuous steroid, 3)Serios complications (heart disease within 3 months, chronic heart failure, neurovascular disease wtih 3 months, uncontrolled disease), 4) para-aortic lymph node swelling (>= 10mm assessed by abdominal computed tomography), 5)Judged to be ineligible for this protocol by the attending physicians

Design outcomes

Primary

Measure	Time frame
3-year overall survival	—

Secondary

Measure	Time frame
initial tumor response, protocol completion rate, 2-year overall survival rate, 2- and 3-year overall survival rate, 3-year loco-regional contorol rate, pattern of failure(initial site), acute adverse events(based on CTCAE ver3.0: hematological and non-hematological), late adverse events (based on RTOG/EORTC late radiatoin morbidity scoring schema: small instestine/colon, rectum, bladder)	—

Countries

Japan

Contacts

Public ContactYuzuru Niibe

Kitasato University School of Medicine Dept. of Radiology and Radiation Oncology

joe-n@hkg.odn.ne.jp042-778-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026