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Phase II prospective multicenter clinical study for pulsed low-dose rate intensity-modulated radiotherapy for local recurrent esophageal squamous cell carcinoma after radiotherapy

Phase II prospective multicenter clinical study for pulsed low-dose rate intensity-modulated radiotherapy for local recurrent esophageal squamous cell carcinoma after radiotherapy

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900020609
Enrollment
Unknown
Registered
2019-01-10
Start date
2019-01-01
Completion date
Unknown
Last updated
2019-01-14

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

Conditions

esophageal squamous cell carcinoma

Interventions

Case series:pulsed low-dose rate intensity-modulated radiotherapy

Sponsors

Mianyang Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years male and female; 2. The patient was confirmed by pathology as esophageal squamous cell carcinoma. 3. For esophageal squamous cell carcinoma patients with local recurrence and/or lymph node metastasis in the original irradiation field after radiotherapy and chemotherapy; 4. The physical condition of the patients was scored 0-2 according to ECOG (WHO) standard; 5. The patient can not tolerate surgery or the tumor can not be resected by surgery; 6. Consciousness, can cooperate with placement and treatment; 7. Previous radiotherapy information can be obtained, including total dose of target area, partition mode, dose distribution, radiation dose to normal tissue and isodose curve, etc.; 8. There must be measurable solid tumors (efficacy evaluation criteria: RECIST 1.1); 9. Women of childbearing age must be in a non-pregnant state (pregnancy test is negative, menopausal women are considered infertile after 12 months of menopause). Women and men of childbearing age should take effective contraceptive measures during the study period and within 3 months after the end of the study; 10. Absolute neutrophil count (ANC) > 1.0 * 10 ^ 9 / L;Platelet (PLT) > 75*10^9/L; 11. Subjects must sign a written informed consent and be willing to participate in and complete the study and follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients with other malignant tumors or distant metastasis; 2. Patients who underwent overirradiation in the target area within 4 weeks before entering this study; 3. History of telangiectatic ataxia or other radiosensitivity reactions has been reported in the past; 4. Scleroderma or active connective tissue disease; 5. Severe uncontrollable infectious diseases; 6. Diseases such as epilepsy with cardio-cerebrovascular complications associated with severe mental disorders or mental disorders may limit the understanding, implementation and treatment compliance of informed consent.

Design outcomes

Primary

MeasureTime frame
Esophageal fistula;Objective remission rate;

Countries

China

Contacts

Public ContactZhao ZhenHua

Mianyang Central Hospital

lijie.7181@163.com+86 15228324561

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 21, 2026