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Prospective study of carbon ion radiotherapy in refractory gynecological malignancies

Prospective observational clinical study of carbon ion radiotherapy in refractory gynecological malignancies

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114705
Enrollment
Unknown
Registered
2025-12-16
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Refractory gynecological malignancies

Interventions

Refractory gynecological malignancies:N/A

Sponsors

Zhejiang Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1.Pathologically confirmed gynecological malignant tumors (including cervical cancer, endometrial cancer, vaginal cancer, vulvar cancer, ovarian cancer, and other malignant tumors of special gynecological pathological types); 2.Recurrent/metastatic or advanced primary gynecological malignancies, with lesions unresponsive to conventional photon radiotherapy; 3.The patient's condition has been discussed within the department and with the hospital’s multidisciplinary team (MDT), and carbon ion radiotherapy is indicated; 4.The patient voluntarily agrees to receive carbon ion radiation therapy at Zhejiang Cancer Hospital and assumes the related costs; 5.Pelvic MRI imaging data within 2 weeks before radiotherapy; pelvic MRI imaging data after 20 fractions of external radiotherapy (prior to brachytherapy); pelvic MRI imaging data within 1 month after completion of pelvic radical dose radiotherapy and at 3 months and 6 months post-radiotherapy. 6.Complete clinical and imaging data; 7.The patient is willing to participate in the study and accept questionnaire surveys; 8.The patient is willing to participate in the study and provide tissue and various body fluid samples; 9.The patient is willing to undergo regular follow-up in the hospital’s outpatient department.

Exclusion criteria

Exclusion criteria: 1.Previous history of >=2 pelvic external radiotherapy sessions (pelvic field recurrence); 2.Received any radioactive particle implantation treatment within the treatment area; 3.The dose limits for critical organs cannot meet the preset safety dose; 4.Presence of metal implants along the radiation field path that may affect the accuracy of radiotherapy dose calculation; 5.The patient has had or currently has any other second primary malignancies; 6.Lack of pathological confirmation of the primary lesion; 7.The possibility of double primary or multiple primary tumors cannot be excluded; 8.The patient requests to withdraw from the study.

Design outcomes

Primary

MeasureTime frame
Progression-Free Survival (PFS);

Countries

China

Contacts

Public ContactZhuomin Yin

Zhejiang Cancer Hospital

yinzm@zjcc.org.cn+86 571 88122032

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026