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Locally Advanced Esophageal Cancer Treated with Photon Radiotherapy Combined With Carbon Ion Radiotherapy Local Boost: Phase III Clinical Trial

Locally Advanced Esophageal Cancer Treated with Photon Radiotherapy Combined With Carbon Ion Radiotherapy Local Boost: Phase III Clinical Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048397
Enrollment
Unknown
Registered
2021-07-06
Start date
2021-07-06
Completion date
Unknown
Last updated
2022-03-14

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

Conditions

Esophageal cancer

Interventions

Experimental group:Photon radiotherapy combined with carbon ion radiotherapy

Sponsors

Gansu Wuwei Tumor Hospital Heavy Ion Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.The pathology confirmed squamous or adenocarcinoma; 2.AJCC 2017 8th Edition CT1-4 any N M0 (Table 5.1); 3.Renal function, liver function and bone marrow function were basically normal (serum creatinine 9.5 g/dL. White blood cell count,>=3000 / ml; Platelet count >= 100,000 /mL); 7.Aged 18 to 80 years; 8.Good physical condition, ECOG (Eastern United States Collaborative Oncology Group) =6 months; 10.Prior to radiotherapy, the patient or his/her legal representative has signed the informed consent.

Exclusion criteria

Exclusion criteria: 1.Patients with esophageal tracheal fistula or who have been judged by physicians to be at high risk of esophageal tracheal fistula: 2.Weight loss of more than 20% within six months; 3.Pregnancy (confirmed by serum or urine ß-HCG test) or lactation period; 4.Drug or alcohol abuse; 5.AIDS patients; 6.Concomitant with uncontrolled systemic, pulmonary or heart disease; 7.Concomitant serious comorbidities, including uncontrolled comorbidities (pulmonary insufficiency, cardiovascular, lung, liver, kidney, diabetes, etc.), addiction, and/or mental illness that prevent the trial regimen from proceeding smoothly; 8.Implant pacemaker or other metal prosthesis enough to affect radiotherapy; 9.Patients with poor compliance, including the possibility of failing to complete the treatment plan or receiving the required follow-up and testing; 10.Previous experience with other malignant tumors (except non-malignant melanoma skin cancer or non-invasive cervical cancer); 11.Simultaneously receiving systemic immunotherapy or corticosteroid therapy; 12.Serum creatinine clearance rate < 30ml/ min; 13.Contraindications to radiotherapy; 14.Participated in other drug clinical trials within 30 days prior to inclusion in this study; 15.Incapacity or limited capacity for civil conduct; 16.Any medical history that, in the investigator's judgment, may interfere with trial results or increase patient risk; 17.Any circumstances in which the physician deems it inappropriate to participate in the trial; 18.Distant metastasis to solid organs; 19.Received radiation therapy for esophageal cancer.

Design outcomes

Primary

MeasureTime frame
Local control rate of tumor;Tumor response rate;

Secondary

MeasureTime frame
Median progression-free survival;Median survival;Distant metastasis rate;

Countries

China

Contacts

Public ContactZhang Yanshan

Gansu Wuwei Tumor Hospital Heavy Ion Center

13830510999@163.com+86 13830510999

Outcome results

None listed

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