Esophageal CancerNCT03113214
PET/CT-directed Hyperfractionated Radiation Dose Escalation in Esophageal Cancer
A study testing radiochemotherapy 1, radiochemotherapy 2 and radiochemotherapy 3 in people with Esophageal Cancer, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The goal of this study is to find the maximum tolerable dose of radiation that can be delivered with concurrent chemotherapy (carboplatin \& paclitaxel) in patients with esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- radiochemotherapy 1, radiochemotherapy 2 and radiochemotherapy 3
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2017to 2 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patients with distant metastasis and life expectancy >/= 3 months are eligible.
- Zubrod performance status 0 to 2
- No prior radiation to the thorax that would overlap with the current treatment field.
Show all 9Show fewer
- 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. 1 0. Induction chemotherapy is allowed
Who cannot join
- The presence of a fistula.
- Prior radiotherapy that would overlap the radiation fields.
- gastroesophageal junction cancer.
- Uncontrolled concurrent illness including, but not limited to: Chronic 5.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.
- 6.Known hypersensitivity to paclitaxel. 7.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. 8.Conditions precluding medical follow-up and protocol compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of PET/CT-directed Hyperfractionated Radiation Dose Escalation With Concurrent Weekly Carboplatin and Paclitaxel in Esophageal Cancer
The goal of this study is to find the maximum tolerable dose of radiation that can be delivered with concurrent chemotherapy (carboplatin \& paclitaxel) in patients with esophageal cancer.
Read the detailed description
Concurrent chemoradiotherapy is the standard of care for esophageal cancer based on the results of phase III randomised trials. The current standard radiation therapy dose has remained 50 Gy at -2 Gy/fraction for decades.However, locoregional control 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.Investigators hypothesize that hyperfractionated radiation dose escalation to residual tumor volumes after standard chemoradiotherapy as defined by positron emission tomography (PET) /computed tomography (CT) would improve local control and overall survival while reducing the acute and late normal tissue toxicity.
- Conditions
- Esophageal Cancer
- Being tested
- radiochemotherapy 1, radiochemotherapy 2, radiochemotherapy 3, radiochemotherapy 4, radiochemotherapy 5
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiochemotherapy 1Radiation
Also called concurrent 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 to residual tumor volume as defined by PET/CT; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2, weekly; paclitaxel, 45-50 mg/m2, weekly
radiochemotherapy 2Radiation
Also called concurrent 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 to residual tumor volume as defined by PET/CT;
radiochemotherapy 3Radiation
Also called concurrent chemoradiotherapy regimen 3
concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 21.6 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT;
radiochemotherapy 4Radiation
Also called concurrent chemoradiotherapy regimen 4
concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 28.8 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT;
radiochemotherapy 5Radiation
Also called concurrent chemoradiotherapy regimen 5
concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 36 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT;
radiochemotherapy 6Radiation
Also called concurrent chemoradiotherapy regimen 6
concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 43.2 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT;
| Study group | Role | What they receive |
|---|---|---|
| radiochemotherapy 1 | Experimental | Patients will be treated with radiation therapy 57.2 Gy. Receives: Radiation: radiochemotherapy 1 |
| radiochemotherapy 2 | Experimental | Patients will be treated with radiation therapy 64.4 Gy. Receives: Radiation: radiochemotherapy 2 |
| radiochemotherapy 3 | Experimental | Patients will be treated with radiation therapy 71.6 Gy. Receives: Radiation: radiochemotherapy 3 |
| radiochemotherapy 4 | Experimental | Patients will be treated with radiation therapy 78.8 Gy. Receives: Radiation: radiochemotherapy 4 |
| radiochemotherapy 5 | Experimental | Patients will be treated with radiation therapy 86 Gy. Receives: Radiation: radiochemotherapy 5 |
| radiochemotherapy 6 | Experimental | Patients will be treated with radiation therapy 93.2 Gy. Receives: Radiation: radiochemotherapy 6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
Maximum Tolerated Dose is defined as CTCAE 4 grade 3 acute radiation-related toxicity
Measured: 1 year
Secondary outcomes (1)
Time to Local Failure
Local control will be assessed radiographically using endoscopy with biopsy and a positron emission computed tomography-CT scan
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start2 Feb 2017
- Primary completion10 Jan 2019
- Study completion2 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen tingfeng, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Tingfeng Chen, MD, Study director, the ethic committee of shanghai genernal hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113214
- Sponsor's protocol ID
- SGH201713
- Status last verified
- Apr 2018
- First submitted
- 10 Apr 2017
- Last updated
- 5 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of PET/CT-directed Hyperfractionated Radiation Dose Escalation With Concurrent Weekly Carboplatin and Paclitaxel in Esophageal Cancer
- ClinicalTrials.gov ID
- NCT03113214
- Acronym / sponsor ID
- SGH201713
- Conditions
- Esophageal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 2 Feb 2019 (actual)
- First posted
- 13 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to find the maximum tolerable dose of radiation that can be delivered with concurrent chemotherapy (carboplatin \& paclitaxel) in patients with esophageal cancer.
Detailed description
Concurrent chemoradiotherapy is the standard of care for esophageal cancer based on the results of phase III randomised trials. The current standard radiation therapy dose has remained 50 Gy at -2 Gy/fraction for decades.However, locoregional control 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.Investigators hypothesize that hyperfractionated radiation dose escalation to residual tumor volumes after standard chemoradiotherapy as defined by positron emission tomography (PET) /computed tomography (CT) would improve local control and overall survival while reducing the acute and late normal tissue toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| radiochemotherapy 1 | Experimental | Radiation: radiochemotherapy 1Patients will be treated with radiation therapy 57.2 Gy. |
| radiochemotherapy 2 | Experimental | Radiation: radiochemotherapy 2Patients will be treated with radiation therapy 64.4 Gy. |
| radiochemotherapy 3 | Experimental | Radiation: radiochemotherapy 3Patients will be treated with radiation therapy 71.6 Gy. |
| radiochemotherapy 4 | Experimental | Radiation: radiochemotherapy 4Patients will be treated with radiation therapy 78.8 Gy. |
| radiochemotherapy 5 | Experimental | Radiation: radiochemotherapy 5Patients will be treated with radiation therapy 86 Gy. |
| radiochemotherapy 6 | Experimental | Radiation: radiochemotherapy 6Patients will be treated with radiation therapy 93.2 Gy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Patients with distant metastasis and life expectancy >/= 3 months are eligible.
- Zubrod performance status 0 to 2
Key exclusion criteria (6 listed)
- The presence of a fistula.
- Prior radiotherapy that would overlap the radiation fields.
- gastroesophageal junction cancer.
- Uncontrolled concurrent illness including, but not limited to: Chronic 5.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.
- 6.Known hypersensitivity to paclitaxel. 7.Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiochemotherapy 1Also: concurrent radiochemotherapy 1concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 7.2 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2, weekly; paclitaxel, 45-50 mg/m2, weekly | Radiation | radiochemotherapy 1 |
| radiochemotherapy 2Also: concurrent radiochemotherapy 2concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT; | Radiation | radiochemotherapy 2 |
| radiochemotherapy 3Also: concurrent chemoradiotherapy regimen 3concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 21.6 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT; | Radiation | radiochemotherapy 3 |
| radiochemotherapy 4Also: concurrent chemoradiotherapy regimen 4concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 28.8 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT; | Radiation | radiochemotherapy 4 |
| radiochemotherapy 5Also: concurrent chemoradiotherapy regimen 5concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 36 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT; | Radiation | radiochemotherapy 5 |
| radiochemotherapy 6Also: concurrent chemoradiotherapy regimen 6concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 43.2 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT; | Radiation | radiochemotherapy 6 |
Primary outcome
Maximum Tolerated Dose
Time frame: 1 year
Maximum Tolerated Dose is defined as CTCAE 4 grade 3 acute radiation-related toxicity
1 secondary outcome
Time to Local Failure
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Esophageal Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tingfeng Chen, MD study director
the ethic committee of shanghai genernal hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiochemotherapy 1, radiochemotherapy 2 and radiochemotherapy 3 in people with Esophageal Cancer, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2019.