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A prospective open-randomized controlled trial comparing postoperative chemoradiotherapy versus chemotherapy for cervical cancer patients with lymph node metastases.

A prospective open-randomized controlled trial comparing postoperative chemoradiotherapy versus chemotherapy for cervical cancer patients with lymph node metastases. - Postoperative radiotherapy for cervical cancer.

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-C000000076
Enrollment
170
Registered
2010-04-01
Start date
2005-02-01
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

Patients who had radical hysterectomy for stage IB-IIB cervical cancer, and were certified to have lymph node mestastases histologocally after radical surgery. Patients with only squamous cell carcinoma were eligible.

Interventions

Concurrent chemoradiotherapy (Group A) Whole pelvic irradiation (50 Gy) and CDDP 70mg/m2, each 4 week, 3 times. Chemotherapy (Group B) CDDP 70mg/m2, each 4 week, 3 times.

Sponsors

Study Group of Postoperative radiotherapy for cervical cancer.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. squamous cell carcinoma of the cervix and clinical stage IB-IIB. 2. radical hysterectomy was performed. 3. with histologically certified lymph node metastases. 4. no abnormal findings in laboratory tests. 5. PS is between 0-2. 6. Age is between 20-75. 7. No chemotherapy for other cancer (except cervical cancer) within recent 3 months.

Exclusion criteria

Exclusion criteria: 1. Past history of pelvic surgery (except appendectomy). 2. past history of pelvic irradiation. 3. Positive surgical margin, or positive paraaortic lymph nodes. 4. Estimaated survival is less than 6 months. 5. Renal dysfunction. 6. Acitve infection (Tuberculosis or mycosis) in the pelvis. 7. Active double cancer. 8. Otehr reasons that is not eligible to this trial.

Design outcomes

Primary

MeasureTime frame
Recurrent rata including distant metastases.

Secondary

MeasureTime frame
Late adverse effect Survival

Countries

Japan

Contacts

Public ContactTakahsi Uno, M.D.

Chiba University, Graduate School of Medicine, Department of Radiology

unotakas@faculty.chiba-u.jp043-226-2100

Outcome results

None listed

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