免费获得国外相关药品，最快 1 个工作日回馈药物信息
出境医 / 临床实验 / High Dose PET/CT-guided Intensity Modulated Radiotherapy and Concurrent Chemotherapy in Esophageal Cancer
High Dose PET/CT-guided Intensity Modulated Radiotherapy and Concurrent Chemotherapy in Esophageal Cancer
Study Description
Brief Summary:
To assess the efficacy and feasibility of high-dose intensity-modulated radiotherapy with concurrent weekly paclitaxel and cisplatin for patients with locaregionally esophageal cancer
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Esophageal Cancer | Radiation: high dose radiation therapy with concurrent chemotherapy | Not Applicable |
Detailed Description:
Standard dose chemoradiotherapy (SCRT) results in poor local control for localregionally advanced esopgageal cancer patients. Most local failures occur in the gross tumor volume.[F-18]-fluorodeoxyglucose (FDG) PET/CT can identify residual metabolic disease (RMD). Hyperfractionated radiotherapy allows for delivering a higher dose without increasing late toxicity. Our previous phase I radiation dose escalation trial demonstrated that 86 Gy could be safely delivered to the RMD with concurrent weekly paclitaxel and cisplatin in advanced esophageal cancer.The aim of this phase II study is to examine the efficacy of this regimen.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Trial of High Dose PET/CT-guided Radiation Therapy With Concurrent Weekly Carboplatin and Paclitaxel in Localregionally Advanced Esophageal Cancer |
| Actual Study Start Date : | August 1, 2018 |
| Estimated Primary Completion Date : | August 1, 2021 |
| Estimated Study Completion Date : | April 1, 2022 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: high dose radiochemotherapy
A total dose of 86 Gy to residual metabolic disease with concurrent chemotherapy
|
Radiation: high dose radiation therapy with concurrent chemotherapy
standard dose of 50 Gy concurrent weekly with paclitaxel (45 mg/m2) and carboplatin (area under curve 1.5 ), immediately followed by hyperfractionated radiotherapy boost of 36 Gy in 30 fractions of 1.2 Gy to residual metabolic disease as defined by PET/CT
|
Outcome Measures
Primary Outcome Measures :
- overall survival rate [ Time Frame: one year ]survival time was measured from the date of study enrollment to the date of death or last follow-up
Secondary Outcome Measures :
- acute and late toxicities [ Time Frame: 1 year ]Acute toxicities were graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 4
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients must have FDG-avid and histologically or cytologically proven esophageal cancer.
- 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.
- No prior radiation to the thorax that would overlap with the current treatment field.
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
Contacts and Locations
Contacts
| Contact: Ningning Cheng, MD | 377985364 ext 8119 | ningcnn@163.com | |
| Contact: Yong Liu, MD | 37795364 ext 8119 | drliuyrt@163.com |
Locations
| China | |
| Shanghai General Hospital | Recruiting |
| Shanghai, China | |
| Contact: Ningning Cheng, MD | |
Sponsors and Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
| Study Chair: | Tingfeng Chen, MD | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 1, 2019 | ||||||||
| First Posted Date ICMJE | May 3, 2019 | ||||||||
| Last Update Posted Date | March 18, 2021 | ||||||||
| Actual Study Start Date ICMJE | August 1, 2018 | ||||||||
| Estimated Primary Completion Date | August 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
overall survival rate [ Time Frame: one year ] survival time was measured from the date of study enrollment to the date of death or last follow-up
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
acute and late toxicities [ Time Frame: 1 year ] Acute toxicities were graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 4
|
||||||||
| Original Secondary Outcome Measures ICMJE |
Acute toxicities were graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 4 [ Time Frame: 1 year ] | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | High Dose PET/CT-guided Intensity Modulated Radiotherapy and Concurrent Chemotherapy in Esophageal Cancer | ||||||||
| Official Title ICMJE | Phase II Trial of High Dose PET/CT-guided Radiation Therapy With Concurrent Weekly Carboplatin and Paclitaxel in Localregionally Advanced Esophageal Cancer | ||||||||
| Brief Summary | To assess the efficacy and feasibility of high-dose intensity-modulated radiotherapy with concurrent weekly paclitaxel and cisplatin for patients with locaregionally esophageal cancer | ||||||||
| Detailed Description | Standard dose chemoradiotherapy (SCRT) results in poor local control for localregionally advanced esopgageal cancer patients. Most local failures occur in the gross tumor volume.[F-18]-fluorodeoxyglucose (FDG) PET/CT can identify residual metabolic disease (RMD). Hyperfractionated radiotherapy allows for delivering a higher dose without increasing late toxicity. Our previous phase I radiation dose escalation trial demonstrated that 86 Gy could be safely delivered to the RMD with concurrent weekly paclitaxel and cisplatin in advanced esophageal cancer.The aim of this phase II study is to examine the efficacy of this regimen. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Esophageal Cancer | ||||||||
| Intervention ICMJE | Radiation: high dose radiation therapy with concurrent chemotherapy
standard dose of 50 Gy concurrent weekly with paclitaxel (45 mg/m2) and carboplatin (area under curve 1.5 ), immediately followed by hyperfractionated radiotherapy boost of 36 Gy in 30 fractions of 1.2 Gy to residual metabolic disease as defined by PET/CT
|
||||||||
| Study Arms ICMJE | Experimental: high dose radiochemotherapy
A total dose of 86 Gy to residual metabolic disease with concurrent chemotherapy
Intervention: Radiation: high dose radiation therapy with concurrent chemotherapy
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
50 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | April 1, 2022 | ||||||||
| Estimated Primary Completion Date | August 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Induction chemotherapy is allowed. Exclusion Criteria:
|
||||||||
| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Listed Location Countries ICMJE | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03936179 | ||||||||
| Other Study ID Numbers ICMJE | SGH201921 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
|
||||||||
| IPD Sharing Statement ICMJE |
|
||||||||
| Responsible Party | Chen tingfeng, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | ||||||||
| Study Sponsor ICMJE | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| PRS Account | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | ||||||||
| Verification Date | March 2021 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||
