A phase I/II study of concurrent chemoradiotherapy with irinotecan for advanced or recurrent uterine cancer

A phase I/II study of concurrent chemoradiotherapy with irinotecan for advanced or recurrent uterine cancer - CCRT with CPT-11

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000148

Enrollment

Registered

2005-09-09

Start date

2002-08-01

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

uterine cancer (squamous cell carcinoma, adeno- and/or adenosquamous cell carcinoma, endometrial carcinoma, carcinosarcoma)

Interventions

In chemoradiotherapy with Irinotecan (CPT-11), the determination of its maximum torelated dose and/or recommended dose and the estimation of its effecacy for advanced/recurrent uterine cancer.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: (1) Histologically and/or clinically confirmed uterinecancer newly diagnosed and recurrent cases.(2)disease with measurable lesion.(3) pelvic/para aortic lyphnodes metastases (4)No lung metastases,(5)previous treatments were as follows: chemotherapy(including immune therapy using biological response modifier) and radiotherapy mustnot be done within 4 weeks before recruitment(6)ECOG Performance Status 0-1, (7)Expected survival time is more than 3months (8) Adequate bone marrow function,no severe complications on heart, lung, liver, kidney functions:a)WBC>3,000/mm3, b) platelets >100,000/mm3, c) Hemoglobin >9.5 g/dl, d) AST, ALT 60 Torr, h) ECG normal, 9) fully written informed consent will be obtained

Exclusion criteria

Exclusion criteria: Exclusion criteria (1)the patients with prior radiotherapy whose treatment area of irradiation will be overlaid to ex-treatment area (2)co-existence of active other malignancies (3)severe complications, such as a)infections, diarrhea (watery), ileus, interstistial pneumonitis, lung fibrosis b)too much pleural effusion, ascitic or abdominal ascites c)uncontrollable diabetis mellitus d)other complications which suffer from progressing study (4) pregnant or expected to be pregnant and breast feeding mother (5)known severe hypersensitivity to agent (6)whom the investigator think unappropriate as a candidate

Design outcomes

Primary

Measure	Time frame
adverse events feasibility response	—

Secondary

Measure	Time frame
progression free survival overall survival	—

Countries

Japan

Contacts

Public ContactSatoshi Takeuchi

Natinonal Hospital Organization Kobe Medical Center Gynecologic Oncology

s-take-kmc@zeus.eonet.ne.jp078-791-0111

Outcome results

None listed

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