Esophageal Cancer Clinical Trial
Official title:
Phase II Study of High-dose (86 Gy)Intensity Modulated Radiotherapy and Concurrent Paclitaxel and Cisplatin in Locoregionally Advanced Esophageal Cancer
NCT number | NCT03535207 |
Other study ID # | SGH201802 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2018 |
Est. completion date | June 30, 2022 |
To assess the efficacy and feasibility of high-dose intensity-modulated radiotherapy with concurrent weekly paclitaxel and cisplatin for patients with locoregionally advanced esophageal cancer
Status | Recruiting |
Enrollment | 50 |
Est. completion date | June 30, 2022 |
Est. primary completion date | December 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Histologically confirmed primary squamous cell carcinoma of the esophagus - Age 1 8-75. - Patients must be deemed unresectable disease or patient is not deemed operable due to medical reasons. - Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 - No prior radiation to the thorax that would overlap with the current treatment field. - Patients with nodal involvement are eligible - Adequate bone marrow, renal and hepatic functions as assessed by the following: Hemoglobin >/= 10.0 g/dl, Platelet count >/= 1 00,000/ mm^3,absolute granulocyte count (AGC) =2 × 10^9 cells/L,bilirubin and Aspartate transaminase =1.5 ×upper limit of normal (ULN), Creatinine </ =1 .5 times ULN. - A signed informed consent must be obtained prior to therapy. - Induction chemotherapy is allowed Exclusion Criteria: - The presence of a fistula. - Prior radiotherapy that would overlap the radiation fields. - gastroesophageal junction cancer or the lower third esophageal cancer invading the gastric wall. - Uncontrolled concurrent illness including, but not limited to: Chronic Obstructive Pulmonary Disease(COPD) exacerbation or other respiratory illness, serious uncontrolled infection, symptomatic congestive heart failure (CHF),unstable angina pectoris, uncontrolled hypertension,or psychiatric illness/social situations that would limit compliance with the study requirements. - Known hypersensitivity to paclitaxel. - Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study. - Acquired Immune Deficiency Syndrome. - Conditions precluding medical follow-up and protocol compliance |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Genernal Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine |
China,
Cooper JS, Guo MD, Herskovic A, Macdonald JS, Martenson JA Jr, Al-Sarraf M, Byhardt R, Russell AH, Beitler JJ, Spencer S, Asbell SO, Graham MV, Leichman LL. Chemoradiotherapy of locally advanced esophageal cancer: long-term follow-up of a prospective rand — View Citation
Herskovic A, Martz K, al-Sarraf M, Leichman L, Brindle J, Vaitkevicius V, Cooper J, Byhardt R, Davis L, Emami B. Combined chemotherapy and radiotherapy compared with radiotherapy alone in patients with cancer of the esophagus. N Engl J Med. 1992 Jun 11;326(24):1593-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | overall survival rate | survival time was measured from the date of study enrollment to the date of death or last follow-up | one year | |
Secondary | toxicities | Acute toxicities were graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 4. | 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Terminated |
NCT01624090 -
Mithramycin for Lung, Esophagus, and Other Chest Cancers
|
Phase 2 | |
Recruiting |
NCT05787522 -
Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk
|
||
Not yet recruiting |
NCT05542680 -
Study on the Design and Application of Special Semi Recumbent Cushion for Postoperative Patients With Esophageal Cancer
|
N/A | |
Completed |
NCT03384511 -
The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.
|
Phase 4 | |
Completed |
NCT00003864 -
Docetaxel Plus Carboplatin in Treating Patients With Advanced Cancer of the Esophagus
|
Phase 2 | |
Recruiting |
NCT05491616 -
Nivolumab During Active Surveillance After Neoadjuvant Chemoradiation for Esophageal Cancer: SANO-3 Study
|
Phase 2 | |
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Completed |
NCT00199849 -
NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine
|
Phase 1 | |
Completed |
NCT03756597 -
PAN-study: Pan-Cancer Early Detection Study (PAN)
|
||
Completed |
NCT00400114 -
Sutent Following Chemotherapy, Radiation and Surgery For Resectable Esophageal Cancer
|
Phase 2 | |
Completed |
NCT03652077 -
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
|
Phase 1 | |
Recruiting |
NCT04615806 -
The Value of Lymph Node Dissection of Indocyanine Green-guided Near-infrared Fluorescent Imaging in Esophagectomy
|
N/A | |
Active, not recruiting |
NCT04566367 -
Blue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer
|
N/A | |
Active, not recruiting |
NCT03962179 -
Feasibility and Efficacy of a Combination of a SEMS and Vacuum Wound Treatment (VACStent)
|
N/A | |
Terminated |
NCT01446874 -
Prevention of Post-operative Pneumonia (POPP)
|
Phase 2/Phase 3 | |
Completed |
NCT03468634 -
Raman Probe for In-vivo Diagnostics (During Oesophageal) Endoscopy
|
N/A | |
Active, not recruiting |
NCT02869217 -
Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors
|
Phase 1 | |
Completed |
NCT02810652 -
Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection
|
N/A | |
Recruiting |
NCT01404156 -
Preoperative Chemotherapy vs. Chemoradiation in Esophageal / GEJ Adenocarcinoma
|
Phase 2/Phase 3 |