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Concurrent chemoradiotherapy combined with paclitaxel plus cisplatin for locally advanced esophageal squamous cell carcinoma: a phase II clinical trial of 3DCRT/IMRT

Concurrent chemoradiotherapy combined with paclitaxel plus cisplatin for locally advanced esophageal squamous cell carcinoma: a phase II clinical trial of 3DCRT/IMRT

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017039
Enrollment
Unknown
Registered
2018-07-09
Start date
2019-04-01
Completion date
Unknown
Last updated
2018-07-16

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

Conditions

Esophagus squamous cell carcinoma

Interventions

Case series:Concurrent chemoradiotherapy combined with paclitaxel plus cisplatin with IMRT

Sponsors

Jiangsu Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) signed the informed consent; 2) Aged 18-75 years; 3) histology was diagnosed as esophageal squamous cell carcinoma, initial treatment (unsurgery / radiotherapy / chemotherapy and targeted therapy); 4) locally advanced: T2-4N0M0, TxN1M0 and TxNxM1a (UICC 6th); 5) women who are not pregnant or are breastfeeding are willing to take contraceptive measures in the experiment; 6) no serious hematopoietic function, heart, lung, liver and kidney dysfunction and immune deficiency; 7) organs and bone marrow function normal, defined as follows: white blood cell count > 4, 000/L, hemoglobin more than 9 g/dL (no blood transfusion), neutrophils count > 2, 100/L, platelet count > 100, 000/L, total bilirubin 3 months; 11) there were no other primary tumors or other primary tumors before treatment, but had been under control for more than 5 years; 12) patients who meet the above conditions can be pre enrolled into the group and meet the requirements of the following sub clause (13) after the radiotherapy plan is designed; 13) the limit of normal tissue in the intensity modulated radiation therapy plan accords with the following requirements: the maximum dose of the spinal cord is less than 45 Gy, the double normal lung (double lung -PTV) V20 < 30% and the average dose is less than 15 Gy, and the average dose of the heart is less than 30 Gy.

Exclusion criteria

Exclusion criteria: 1) a complete obstruction of the esophagus can not eat fluid, and there is a deep ulcer or perforation or hematemesis in the esophagus; 2) second primary tumors (cured non malignant melanoma of the skin, papillary thyroid carcinoma, I stage of spermatogonial carcinoma, cervical carcinoma in situ, or other "cured" tumor, except for more than 3 years after treatment; 3) 30 days before randomization, other test drugs or other clinical trials were used; 4) pregnancy, lactation, or fertility, but not contraception; 5) drug addiction, chronic alcoholism, and AIDS patients; 6) myocardial infarction time is less than 6 months. Myocardial infarction time should be detected by TL angiography in >6 months of myocardial infarction; 7) an unexpected seizure or loss of insight due to mental illness; 8) a person with a history of severe allergies or a specific constitution; 9) the researchers think it is not suitable to participate in this experiment; 10) received radiotherapy in this prospective radiotherapy area.

Design outcomes

Primary

MeasureTime frame
2-year local control;

Secondary

MeasureTime frame
Toxic and side effects;

Countries

China

Contacts

Public ContactJinjun Ye

Jiangsu Cancer Hospital

jjye2004@163.com+86 13585175433

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026