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The study for risk factors and potential mechanism of pelvic insufficiency fracture for pelvic malignant tumors after treatment with modern radiotherapy technique

The study for risk factors and potential mechanism of pelvic insufficiency fracture for pelvic malignant tumors after treatment with modern radiotherapy technique

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900024018
Enrollment
Unknown
Registered
2019-06-22
Start date
2019-07-01
Completion date
Unknown
Last updated
2019-06-26

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

Conditions

Gynecological tumor and rectum cancer

Interventions

Rectum cancer group:N/A
Gynecological cancer group:N/A

Sponsors

Jiangmen Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18 to 80 years, PS 0-2.(2) The pathology was diagnosed as rectal adenocarcinoma or cervical squamous cell carcinoma/adenocarcinoma or endometrioid adenocarcinoma/serous carcinoma/clear cell carcinoma within 1 month before inclusion. For rectal cancer, clinical stage T3-4/N+, with no distant metastasis, patients needing preoperative chemoradiotherapy or postoperative chemoradiotherapy. And for cervical cancer / endometrial cancer, patients needing postoperative chemoradiotherapy or radical chemoradiotherapy.(3) One month before inclusion, patients need to complete physical examination, medical history collection, blood routine, blood chemistry, tumor-related markers, TSH, FSH, PTH, ACTH, 25-hydroxy vitamin D, procollagen type I N-terminal propeptide (PINP), CROSSL, osteocalcin, bone mineral density and pelvic MRI, etc. (4) All patients signed the informed consent of inclusion in the clinical trial.

Exclusion criteria

Exclusion criteria: (1) Patients once received pelvic pretreatment radiotherapy before concurrent chemoradiotherapy. (2) Patients with severe comorbidities which make them not tolerate any chemoradiotherapy. (3) Patients with severe obstructive disease. (4) Patients with rheumatoid arthritis; (5) Patients with long-term use of dexamethasone or prednisone.(6) Patients with a history of pelvic trauma and pain.

Design outcomes

Primary

MeasureTime frame
Incidence and location of insufficiency fracture;Dose and volume parameters of pelvic bone marrow;

Secondary

MeasureTime frame
Bone metabolism related hormones, related biochemical markers and bone mineral density;

Countries

China

Contacts

Public ContactXiao Lin

Jiangmen Central Hospital, Jiangmen, Guangdong

xiaolin7966165@126.com+86 13929058809

Outcome results

None listed

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