Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this trial is to find the maximum tolerable dose of radiation that can be delivered combined with chemotherapy (DDP & Paclitaxel) in patients with inoperable or medically unresectable esophageal cancer.
The RTOG 8501 has established concurrent radiochemotherapy as the standard of care for cancer of the esophagus.However, locoregional remain problematic, with 25% of patients having persistence and 20% relapse of locoregional disease following the combined modality approach. New regimen is urgently needed for improving localregional control and survival.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| radiochemotherapy 1 | Experimental | Patients will be treated with radiation therapy 57.2 Gy. |
|
| radiochemotherapy 2 | Experimental | Patients will be treated with radiation therapy 64.4 Gy. |
|
| radiochemotherapy 3 | Experimental | Patients will be treated with radiation therapy 71.6 Gy. |
|
| radiochemotherapy 4 | Experimental | Patients will be treated with radiation therapy 78.8 Gy. |
|
| radiochemotherapy 5 | Experimental | Patients will be treated with radiation therapy 86 Gy. |
|
| radiochemotherapy 6 | Experimental | Patients will be treated with radiation therapy 93.2 Gy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiochemotherapy 1 | Radiation | concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 7.2 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2, weekly; paclitaxel, 45-50 mg/m2, weekly |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Dose Limiting Toxicities (DLTs) Occurring in Participants | The DLTs were defined as grade >/=4 esophatitis, any other grade >/=3 nonhematological toxicity (except nausea and vomiting), or grade >/=4 hematological toxicity lasting more than 7 days, which are possibly, probably, or definitely associated with protocol treatment occurring during and after completion of the HFRT boost treatment. | 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Local Failure | Local failure will be assessed radiographically using endoscopy with biopsy, CT scan, and a positron emission computed tomography-CT scan. which was defined as persistence /recurrence of the tumor in the radiation therapy field. | 15 months |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tingfeng Chen, MD | the ethic committee of shanghai genernal hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Ethic Committee of Shanghai General Hospital | Shanghai | Shanghai Municipality | 210000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10235156 | Background | 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 randomized trial (RTOG 85-01). Radiation Therapy Oncology Group. JAMA. 1999 May 5;281(17):1623-7. doi: 10.1001/jama.281.17.1623. | |
| 1584260 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Radiochemotherapy 1 | Patients will be treated with radiation therapy 57.2 Gy. radiochemotherapy 1: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 7.2 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2, weekly; paclitaxel, 45-50 mg/m2, weekly |
| FG001 | Radiochemotherapy 2 | Patients will be treated with radiation therapy 64.4 Gy. radiochemotherapy 2: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly |
| FG002 | Radiochemotherapy 3 | Patients will be treated with radiation therapy 71.6 Gy. radiochemotherapy 3: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 21.6 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly |
| FG003 | Radiochemotherapy 4 | Patients will be treated with radiation therapy 78.8 Gy. radiochemotherapy 4: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 28.8 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly |
| FG004 | Radiochemotherapy 5 | Patients will be treated with radiation therapy 86 Gy. radiochemotherapy 5: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 36 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly; |
| FG005 | Radiochemotherapy 6 | Patients will be treated with radiation therapy 93.2 Gy. radiochemotherapy 6: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 43.2 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Radiochemotherapy 1 | 3 Patients will be treated with radiation therapy 57.2 Gy. radiochemotherapy 1: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 7.2 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2, weekly; paclitaxel, 45-50 mg/m2, weekly |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Dose Limiting Toxicities (DLTs) Occurring in Participants | The DLTs were defined as grade >/=4 esophatitis, any other grade >/=3 nonhematological toxicity (except nausea and vomiting), or grade >/=4 hematological toxicity lasting more than 7 days, which are possibly, probably, or definitely associated with protocol treatment occurring during and after completion of the HFRT boost treatment. | Posted | Number | dose limiting toxicity | 15 months |
|
15 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Radiochemotherapy 1 | Patients will be treated with radiation therapy 57.2 Gy. radiochemotherapy 1: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 57.2 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| grade 3 pneumotitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr tingfeng Chen | Department of Radiation Oncology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China | 86-021-37798364 | tingfeng138138@163.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 20, 2020 | Apr 28, 2020 | Prot_SAP_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
open label
Not provided
|
|
| radiochemotherapy 2 | Radiation | concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly |
|
|
| radiochemotherapy 3 | Radiation | concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 21.6 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly |
|
|
| radiochemotherapy 4 | Radiation | concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 28.8 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly |
|
|
| radiochemotherapy 5 | Radiation | concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 36 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly; |
|
|
| radiochemotherapy 6 | Radiation | concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 43.2 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly |
|
|
| Background |
| 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. doi: 10.1056/NEJM199206113262403. |
| Radiochemotherapy 2 |
3 Patients will be treated with radiation therapy 64.4 Gy. radiochemotherapy 2: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly |
| BG002 | Radiochemotherapy 3 | 3 Patients will be treated with radiation therapy 71.6 Gy. radiochemotherapy 3: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 21.6 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly |
| BG003 | Radiochemotherapy 4 | 6 Patients will be treated with radiation therapy 78.8 Gy. radiochemotherapy 4: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 28.8 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly |
| BG004 | Radiochemotherapy 5 | 13 Patients will be treated with radiation therapy 86 Gy. radiochemotherapy 5: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 36 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly; |
| BG005 | Radiochemotherapy 6 | 3 Patients will be treated with radiation therapy 93.2 Gy. radiochemotherapy 6: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 43.2 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Eastern Cooperative Oncology Group, ECOG performance status 0-1 | GRADE ECOG PERFORMANCE STATUS 0 Fully active, able to carry on all pre-disease performance without restriction
| Count of Participants | Participants |
|
| Arm 2: Radiochemotherapy 2 |
Patients will be treated with radiation therapy 64.4 Gy. radiochemotherapy 2: concurrent radiochemotherapy: radiotherapy dose level 2: 50 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly; |
| OG002 | Arm 3：Radiochemotherapy 3 | Patients will be treated with radiation therapy 71.6 Gy. radiochemotherapy 3: concurrent radiochemotherapy: radiotherapy dose level 3: 50 Gy at 2 Gy/Fx/d, then 21.6 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly; |
| OG003 | Arm 4: Radiochemotherapy 4 | Patients will be treated with radiation therapy 78.8 Gy. radiochemotherapy 4: concurrent radiochemotherapy: radiotherapy dose level 4: 50 Gy at 2 Gy/Fx/d, then 28.8 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly; |
| OG004 | Arm 5: Radiochemotherapy 5 | Patients will be treated with radiation therapy 86 Gy. radiochemotherapy 5: concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 36 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly; |
| OG005 | Arm 6: Radiochemotherapy 6 | Patients will be treated with radiation therapy 93.2 Gy. radiochemotherapy 6: concurrent radiochemotherapy: radiotherapy dose level 6: 50 Gy at 2 Gy/Fx/d, then 43.2 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly; |
|
|
| Secondary | Local Failure | Local failure will be assessed radiographically using endoscopy with biopsy, CT scan, and a positron emission computed tomography-CT scan. which was defined as persistence /recurrence of the tumor in the radiation therapy field. | the patients who completed the protocol treatment | Posted | Count of Participants | Participants | 15 months |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | Arm 2: Radiochemotherapy 2 | Patients will be treated with radiation therapy 64.4 Gy. radiochemotherapy 2: concurrent radiochemotherapy: radiotherapy dose level 2: 50 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly | 0 | 3 | 0 | 3 | 3 | 3 |
| EG002 | Arm 3: Radiochemotherapy 3 | Patients will be treated with radiation therapy 71.6 Gy. radiochemotherapy 3: concurrent radiochemotherapy: radiotherapy dose level 3: 50 Gy at 2 Gy/Fx/d, then 21.6 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly | 0 | 3 | 0 | 3 | 3 | 3 |
| EG003 | Arm 4: Radiochemotherapy 4 | Patients will be treated with radiation therapy 78.8Gy. radiochemotherapy 4: concurrent radiochemotherapy: radiotherapy dose level 4: 50 Gy at 2 Gy/Fx/d, then 28.8 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly | 0 | 6 | 0 | 6 | 5 | 6 |
| EG004 | Arm 5: Radiochemotherapy | Patients will be treated with radiation therapy 36 Gy. radiochemotherapy 5: concurrent radiochemotherapy: radiotherapy dose level 5: 50 Gy at 2 Gy/Fx/d, then 36 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly | 0 | 13 | 0 | 13 | 11 | 13 |
| EG005 | Arm 6: Radiochemotherapy 6 | Patients will be treated with radiation therapy 93.2 Gy. radiochemotherapy 6: concurrent radiochemotherapy: radiotherapy dose level 6: 50 Gy at 2 Gy/Fx/d, then 43.2 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly | 1 | 3 | 2 | 3 | 1 | 3 |
| grade 5 esophageal fistula | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
Not provided
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|