Esophageal Squamous Cell Carcinoma Clinical Trial
Official title:
A Phase III Study of Comparing 61.2 Gy Radiotherapy Dose Versus 50.4 Gy Radiotherapy Dose for Locally Advanced Esophageal Carcinoma
Verified date | August 2023 |
Source | Fudan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determined the best definitive radiotherapy dosage for patients with locally advanced esophageal squamous cell carcinoma.
Status | Recruiting |
Enrollment | 646 |
Est. completion date | October 15, 2025 |
Est. primary completion date | October 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Joined the study voluntarily and signed informed consent form; - Age 18-75 years; both genders - Esophageal squamous cell carcinoma confirmed by pathology. - No radiotherapy, chemotherapy or other treatments prior to enrollment - Locally advanced esophageal squamous cell carcinoma (T1N1-3M0, T2-4NxM0, TxNxM1 (supraclavicular lymph node metastasis only) (AJCC 8th) - Use of an effective contraceptive for adults to prevent pregnancy. - No severely abnormal hematopoietic, cardiac, pulmonary, renal, or hepatic function. No immunodeficiency. - WBC = 3.5*109/L, Hemoglobin = 9 g/dL, Neutrophils = 1·5*109/L, Platelet count = 100*109/L, ALAT and ASAT < 2·5 * ULN, TBIL < 1·5 * ULN, and Creatinine < 1·5 *ULN. - ECOG 0-2. - Life expectancy of more than 3 months. - Agreement of PET/CT accessment at 25-28 radiotherapy fraction. Exclusion Criteria: - Total radiotherapy dose cannot reach 61.2Gy/34Fx in the condition of the nomal tissue dose complying to the standard criteria. - Esophageal perforation, or hematemesis. - History of radiotherapy or chemotherapy for esophageal cancer. - History of surgery within 28 days before Day 1. - History of prior malignancies (other than skin basal cell carcinoma or cervical carcinoma in situ with a disease-free survival of at least 3 years). - Participation in other interventional clinical trials within 30 days. - Pregnant or breast-feeding women or fertile patients who refused to use contraceptives. - Drug addiction, alcoholism or AIDS. - Uncontrolled seizures or psychiatric disorders. - Any other condition which in the investigator's opinion would not make the patient a good candidate for the clinical trial. |
Country | Name | City | State |
---|---|---|---|
China | Jiangsu Cancer Hospital | Nanjing | Jiangsu |
China | Fudan Universtiy Shanghai Cancer Center | Shanghai | Shanghai |
China | Huadong Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Fudan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival in PET/CT non-responders | The time between the start of the study treatment (Day 1) and death from any cause or last follow-up for patients alive at the end of the study. | 2 years | |
Primary | Overall survival in ITT population | The time between the start of the study treatment (Day 1) and death from any cause or last follow-up for patients alive at the end of the study. | 2 years | |
Secondary | Local control rate | The time between the start of the study treatment (Day 1) and local reccurence (included the primary tumor and regional lymph node failure) | 2 years | |
Secondary | Progression-free survival | (defined as the time between Day 1 and the first event of local failure, metastatic recurrence, progression or death) | 2 years | |
Secondary | Overall survival in PET/CT responders | Overall survival in patients who have SUV = 4 in PET/CT analysis in 25-28 radiotherapy fractions. | 2 years | |
Secondary | Questionnaire EORTC-QLQ-C30 | A quality of life score is obtained according to the answers to the questionnaires. | 2 years | |
Secondary | Questionnaire EORTC-QLQ-OES18 | A quality of life score is obtained according to the answers to the questionnaires. | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06056336 -
Perioperative Tislelizumab Plus Chemotherapy for Resectable Thoracic Oesophageal Squamous Cell Carcinoma
|
Phase 2 | |
Suspended |
NCT04084158 -
A Study of Toripalimab Combined With Concurrent Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma.
|
Phase 2 | |
Active, not recruiting |
NCT04242199 -
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
|
Phase 1 | |
Not yet recruiting |
NCT05561699 -
Sequential Preoperative Penpulimab Combined With Chemoradiotherapy(CRT) for Locally Advanced Esophageal Squamous Cell Cancer
|
N/A | |
Active, not recruiting |
NCT04543617 -
A Study of Atezolizumab With or Without Tiragolumab in Participants With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy
|
Phase 3 | |
Recruiting |
NCT06190782 -
Local Therapy for Oligometastatic ESCC Patients Treated With PD-1 Inhibitor
|
Phase 3 | |
Completed |
NCT05557955 -
Identification of Breath Biomarkers in Esophageal Cancer
|
||
Recruiting |
NCT04045496 -
A First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT04584008 -
Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics
|
N/A | |
Not yet recruiting |
NCT03766178 -
Study of Anti-PD-1 Antibody SHR-1210 Plus Nimotuzumab in the Treatment of Advanced Esophageal Squamous Cell Carcinoma
|
Phase 2 | |
Recruiting |
NCT02913066 -
S-1 IMRT Versus S-1 and Cisplatin Concurrent IMRT in Inoperable Esophageal Squamous Cell Carcinoma
|
Phase 2 | |
Completed |
NCT02399306 -
Chemoradiotherapy With or Without Enteral Nutrition for Locally Advanced Thoracic Esophageal Carcinoma
|
Phase 3 | |
Completed |
NCT01605305 -
Study on FOLFOX6 as First-line Therapy to Treat Recurrent or Metastatic Esophageal Cancer
|
Phase 2 | |
Not yet recruiting |
NCT05552651 -
Envafolimab Combined With Chemotherapy in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma
|
Phase 2 | |
Recruiting |
NCT05520619 -
Combination of Tislelizumab and Chemoradiotherapy in Esophageal Cancer (EC-CRT-002)
|
Phase 2 | |
Terminated |
NCT03251417 -
Apatinib and Irinotecan Combination Treatment in Unresectable or Metastatic Esophageal Squamous Cell Carcinoma
|
Phase 2 | |
Recruiting |
NCT05990231 -
Cadonilimab/Anlotinib in Locally Advanced or Relapsed/Metastatic ESCC Patients After Failure of PD-1 Combined With Platinum-containing Chemotherapy
|
Phase 2 | |
Recruiting |
NCT04644250 -
Combination of Toripalimab and Neoadjuvant Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma
|
Phase 2 | |
Completed |
NCT02916511 -
Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy Concurrent With Chemotherapy for Esophageal Squamous Cell Carcinoma
|
Phase 2 | |
Terminated |
NCT04032704 -
A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors
|
Phase 2 |