Esophageal CancerPhase 1/2NCT01843049
Dose Escalation by Boosting Radiation Dose Within the Primary Tumor Using 18FDG-PET/CT for Unresectable Thoracic Esophageal Cancer
A Phase 1/2 study testing Radiotherapy and Chemotherapy (5-FU+DDP) in people with Esophageal Cancer, run by Fudan University at 1 site in China.
Trial summary
Most local failures after definitive chemoradiation for unresectable esophageal cancer occur in the gross tumor volume (GTV). And the metabolic active areas post-treatment were located in the high FDG uptake areas prior to the radiotherapy. 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?
- Radiotherapy and Chemotherapy (5-FU+DDP)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Dec 2015
- Phase
- Phase 1/2
- 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
- Histopathologically proven diagnosis of esophageal squamous cell carcinoma.
- ECOG performance status 0-1.
- Able to swallow semifluid diet.
- Patients must not have received either radiotherapy or chemotherapy.
- Technically unresectable, medically inoperable, or surgery declined by the patient.
- SUVmax in the pre-treatment FDG-PET scan > 5 for the primary tumor and the length of the primary tumor ≤10cm.
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- Normal liver and renal function and adequate bone marrow reservation.
- Meet the requirements of the dose limitation to the critical organ: V20≤25%，Dmean≤15Gy for lung; Dmax ≤45Gy for spinal cord，Dmean ≤20Gy for liver.
- Written, signed informed consent.
Who cannot join
- Other malignancy histology.
- Any evidence of visceral metastases.
- Prior radiotherapy to the thorax or systemic therapy for esophageal cancer.
- Evidence of deep esophageal ulcer or esophageal perforation.
- Weight loss ≥10% within half year or cachexia.
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
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- History of cardiac disease: congestive heart failure > NYHA class 2, active CAD, cardiac arrythmias requiring anti-arrhythmic therapy or uncontrolled hypertension within the last 12 months.
- Concurrent uncontrolled medical conditions.
- Pregnant or lactating women.
- Drug addiction, alcoholism or AIDS.
- Uncontrolled seizures or psychiatric, behavioural disorders.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
About this study
Official title: Dose Escalation Using a Simultaneous Integrated Boost Technique Based on 18FDG-PET/CT for Unresectable Thoracic Esophageal Cancer: a Phase I/II Trial
Most local failures after definitive chemoradiation for unresectable esophageal cancer occur in the gross tumor volume (GTV). And the metabolic active areas post-treatment were located in the high FDG uptake areas prior to the radiotherapy. The hypothesis is that selective dose boost to the esophageal GTV could be safely delivered using a simultaneous integrated boost (SIB) technique, and that boosting the high 18F-deoxyglucose (FDG) uptake areas of the esophageal GTV defined prior to treatment may improve local tumor control.
- Conditions
- Esophageal Cancer
- Being tested
- Radiotherapy, Chemotherapy (5-FU+DDP)
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Patients will receive from 5 to 6 weeks 5 days a week radiations. The dose of radiation will depend on the level they will be included.
Chemotherapy (5-FU+DDP)Drug
Patients will receive 2 cycles of concurrent chemotherapy (cisplatin 25mg/m2 IV daily on Days 1-3 and 29-31 plus 5-FU 500mg/m2 IV continuous infusion over 24h daily on Days 1-4 and 29-32) during radiotherapy period. Consolidation chemotherapy (cisplatin 25mg/m2 IV daily on Days 1-3 plus 5-FU 600mg/m2 IV daily on Days 1-5, cycled every 4 weeks) will be given for 2 cycles one month after the end of radiochemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| radiotherapy+chemotherapy | Experimental | Radiotherapy:
LEVEL 1: dose given at PTV-G and PTV-C will be 64Gy/32 fractions and 50Gy/25 fractions.
LEVEL 2: dose given at PTV-G and PTV-C will be 63Gy/28 fractions and 50.4Gy/28 fractions.
LEVEL 3: dose given at PTV-GR (with an integrated boost to the 50% SUVmax area of the primary tumor of the pre-treatment 18FDG-PET/CT scan), PTV-G and PTV-C will be 70Gy/28 fractions, 63Gy/28 fractions and 50.4Gy/28 fractions.
LEVEL 4: dose given at PTV-GR (with an integrated boost to the 50% SUVmax area of the primary tumor of the pre-treatment 18FDG-PET/CT scan), PTV-G and PTV-C will be 70Gy/25 fractions, 62.5Gy/25 fractions and 50Gy/25 fractions.
Chemotherapy:
Concurrent chemotherapy: Cisplatin 25mg/m2 IV daily on Days 1-3 and 29-31 plus 5-FU 500mg/m2 IV continuous infusion over 24 hours daily on Days 1-4 and 29-32.
Consolidation chemotherapy: Cisplatin 25mg/m2 IV daily on Days 1-3 plus 5-FU 600mg/m2 IV daily on Days 1-5, cycled every 4 weeks for 2 cycles. Receives: Radiation: Radiotherapy; Drug: Chemotherapy (5-FU+DDP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity(DLT)
Measured: 3 months after the finish of the radiotherapy
Secondary outcomes (4)
Overall survival (OS)
Measured: 3 years
Progression-free survival (PFS)
Measured: 3 years
Failure patterns
Measured: 3 years
Late toxicity
Esophageal perforation, esophageal bleeding or late radiation-induced lung or heart injury of grade 3 or above(CTCAE3.0)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaolong Fu, Fudan University
- Investigators
- Xiaolong Fu, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843049
- Sponsor's protocol ID
- 2013ESO_FU_01
- Status last verified
- Apr 2013
- First submitted
- 24 Apr 2013
- Last updated
- 30 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yu W, Cai XW, Liu Q, Zhu ZF, Feng W, Zhang Q, Zhang YJ, Yao ZF, Fu XL. Safety of dose escalation by simultaneous integrated boosting radiation dose within the primary tumor guided by (18)FDG-PET/CT for esophageal cancer. Radiother Oncol. 2015 Feb;114(2):195-200. doi: 10.1016/j.radonc.2014.12.007. Epub 2015 Jan 10.
PubMed 25586952
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Escalation Using a Simultaneous Integrated Boost Technique Based on 18FDG-PET/CT for Unresectable Thoracic Esophageal Cancer: a Phase I/II Trial
- ClinicalTrials.gov ID
- NCT01843049
- Acronym / sponsor ID
- 2013ESO_FU_01
- Conditions
- Esophageal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (estimated)
- First posted
- 30 Apr 2013 (estimated)
- 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.
Most local failures after definitive chemoradiation for unresectable esophageal cancer occur in the gross tumor volume (GTV). And the metabolic active areas post-treatment were located in the high FDG uptake areas prior to the radiotherapy. The hypothesis is that selective dose boost to the esophageal GTV could be safely delivered using a simultaneous integrated boost (SIB) technique, and that boosting the high 18F-deoxyglucose (FDG) uptake areas of the esophageal GTV defined prior to treatment may improve local tumor control.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| radiotherapy+chemotherapy | Experimental | Radiation: Radiotherapy, Drug: Chemotherapy (5-FU+DDP)Radiotherapy: LEVEL 1: dose given at PTV-G and PTV-C will be 64Gy/32 fractions and 50Gy/25 fractions. LEVEL 2: dose given at PTV-G and PTV-C will be 63Gy/28 fractions and 50.4Gy/28 fractions. LEVEL 3: dose given at PTV-GR (with an integrated boost to the 50% SUVmax area of the primary tumor of the pre-treatment 18FDG-PET/CT scan), PTV-G and PTV-C will be 70Gy/28 fractions, 63Gy/28 fractions and 50.4Gy/28 fractions. LEVEL 4: dose given at PTV-GR (with an integrated boost to the 50% SUVmax area of the primary tumor of the pre-treatment 18FDG-PET/CT scan), PTV-G and PTV-C will be 70Gy/25 fractions, 62.5Gy/25 fractions and 50Gy/25 fractions. Chemotherapy: Concurrent chemotherapy: Cisplatin 25mg/m2 IV daily on Days 1-3 and 29-31 plus 5-FU 500mg/m2 IV continuous infusion over 24 hours daily on Days 1-4 and 29-32. Consolidation chemotherapy: Cisplatin 25mg/m2 IV daily on Days 1-3 plus 5-FU 600mg/m2 IV daily on Days 1-5, cycled every 4 weeks for 2 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histopathologically proven diagnosis of esophageal squamous cell carcinoma.
- ECOG performance status 0-1.
- Able to swallow semifluid diet.
- Patients must not have received either radiotherapy or chemotherapy.
- Technically unresectable, medically inoperable, or surgery declined by the patient.
Key exclusion criteria (11 listed)
- Other malignancy histology.
- Any evidence of visceral metastases.
- Prior radiotherapy to the thorax or systemic therapy for esophageal cancer.
- Evidence of deep esophageal ulcer or esophageal perforation.
- Weight loss ≥10% within half year or cachexia.
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 |
|---|---|---|
| RadiotherapyPatients will receive from 5 to 6 weeks 5 days a week radiations. The dose of radiation will depend on the level they will be included. | Radiation | radiotherapy+chemotherapy |
| Chemotherapy (5-FU+DDP)Patients will receive 2 cycles of concurrent chemotherapy (cisplatin 25mg/m2 IV daily on Days 1-3 and 29-31 plus 5-FU 500mg/m2 IV continuous infusion over 24h daily on Days 1-4 and 29-32) during radiotherapy period. Consolidation chemotherapy (cisplatin 25mg/m2 IV daily on Days 1-3 plus 5-FU 600mg/m2 IV daily on Days 1-5, cycled every 4 weeks) will be given for 2 cycles one month after the end of radiochemotherapy. | Drug | radiotherapy+chemotherapy |
Primary outcome
Dose limiting toxicity(DLT)
Time frame: 3 months after the finish of the radiotherapy
4 secondary outcomes
Overall survival (OS)
Time frame: 3 years
Progression-free survival (PFS)
Time frame: 3 years
Failure patterns
Time frame: 3 years
Late toxicity
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2013.
- Derived from this study: PubMed 25586952Yu W, Cai XW, Liu Q, Zhu ZF, Feng W, Zhang Q, Zhang YJ, Yao ZF, Fu XL. Safety of dose escalation by simultaneous integrated boosting radiation dose within the primary tumor guided by (18)FDG-PET/CT for esophageal cancer. Radiother Oncol. 2015 Feb;114(2):195-200. doi: 10.1016/j.radonc.2014.12.007. Epub 2015 Jan 10.
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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.
Xiaolong Fu, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Radiotherapy and Chemotherapy (5-FU+DDP) in people with Esophageal Cancer, run by Fudan University 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 11 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: status not confirmed, as of the sponsor's last update on 30 Apr 2013. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen Yu, MD, PHD (8621-64175590 ext. 1505, yuzhiwen0827@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity(DLT) (time frame: 3 months after the finish of the radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01843049, which also lists 1 linked publication.
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 30 Apr 2013.