Esophageal NeoplasmsPhase 2NCT01670409
Study of Simultaneous Modulated Accelerated Radiation Therapy Concurrent With Chemotherapy to Treat Esophageal Cancer
A Phase 2 study testing SMART and PF in people with Esophageal Neoplasms, run by Chuangzhen Chen at 1 site in China.
Trial summary
The purpose of this study is to evaluate the acute and 2-year late toxicities, the 2-year local control and overall survival rates in patients with esophageal squamous cell carcinoma receiving simultaneous modulated accelerated radiation therapy concurrent with chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Neoplasms
- What is being tested?
- SMART and PF
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- Aug 2012to Aug 2015
- Phase
- Phase 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
- pathological proven diagnosis of primary squamous cell carcinoma of the esophagus
- the primary disease located in cervical, upper or middle thoracic esophagus
- no distant metastases
- zubrod performance status: 0~2
- life expectancy > 6 months; -absence of another malignancy
- adequate liver, renal and bone marrow function
- women of childbearing potential and male participants must practice adequate contraception
- patient must provide study-specific informed consent prior to study entry
Who cannot join
- evidence of tracheoesophageal or Mediastinal-esophageal fistula
- prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years
- prior radiation therapy that would result in overlap of planned radiation therapy fields; - Severe, active comorbidity
- pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
- women who are nursing
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital, Shantou University Medical College
Shantou, Guangdong, 515031
About this study
Official title: A Phase II Study of Simultaneous Modulated Accelerated Radiation Therapy Concurrent With Chemotherapy in Patients With Esophageal Squamous Cell Carcinoma
The purpose of this study is to evaluate the acute and 2-year late toxicities, the 2-year local control and overall survival rates in patients with esophageal squamous cell carcinoma receiving simultaneous modulated accelerated radiation therapy concurrent with chemotherapy.
Read the detailed description
Esophageal cancer is one of the most common malignant diseases in China, especially in Chaoshan region. Concurrent chemoradiotherapy is the standard non-surgical treatment method for this disease and the radiation schedule is about 50.4~60 Gray (Gy) in total, 1.8~2Gy per fraction generally. However, although with such comprehensive method, noncontrol of local disease or recurrence is still the main reason of failure.
Most patients with esophageal cancer suffer from malnutrition. A number of factors including hypoxic, inflammation, radioresistance and accelerated repopulation may contribute to local failures of disease after treatment; therefore a higher radiation biological equivalent dose (BED) will improve the local control probability. Although the intergroup 0123 (INT123) trial had shown that simply increasing total radiation dose could not gain better local control or overall survival rate, however, the ability of this trial to test the potential benefits of higher radiation dose could be compromized by the deficiencies within them, such as, observation bias,large radiated target volume and usage of conventional radiation technique. In other words, the probability that increasing radiation may help improving the control of disease should not be denied.
Modern radiation techniques, such as intensity modulation radiation therapy (IMRT), specially, are able to improve the coverage of target volumes and sparing of critical structures, while increase the total radiation dose. By using simultaneous modulated accelerated radiation therapy (SMART) technique, the doses to the relevant normal organs per fraction could be reduced significantly, while the doses to tumor could be increased to higher than 2Gy. Thus reach the double goal of protection of normal tissues, increasing total radiation Equivalent Uniform Dose (EUD). Dosimetric study has proven the feasibility and superiority of SMART-base IMRT in radiation treatment of esophageal cancer, compared with conventional technique.
Overall, SMART-base IMRT concurrent with chemotherapy may improve the local control and overall survival rate of patients with esophageal cancer; Meanwhile, the acute and late toxicities would be tolerable and slighter than that of conventional technique.
- Conditions
- Esophageal Neoplasms
- Being tested
- SMART, PF
- Keywords
- Esophageal squamous cell carcinoma, SMART, IMRT, Chemotherapy
- Medical subject headings
- Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMARTRadiation
The PTV (planning target volume) of gross tumor will receive radiation dose of 66Gy, 2.2Gy per fraction and the PTV of subclinical disease will receive 54Gy, 1.8Gy per fraction,5 fraction per week.
PFDrug
Also called cisplatin plus 5fluorouracil
Concurrent and adjuvant chemotherapy: Cisplatin, 80mg/m2, intravenous on day 1, 5fluorouracil 0.5/m2, intravenous on d1 to d4. Two cycles during radiation treatment on d1 and d28. Two additional cycles after radiation treatment, 4 weeks per cycle.
| Study group | Role | What they receive |
|---|---|---|
| SMART combined with PF chemotherpay | Experimental | SMART-base IMRT with concurrent and adjuvant chemotherapy(cisplatin and 5-fluorouracil) Receives: Radiation: SMART; Drug: PF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicities
The probabilities of grade ≥ 3 acute toxicities and 2-year late toxicities of esophagus and lungs as assessed by CTCAE 4.0
Measured: The period during treatment and the 2 years after treatment
Secondary outcomes (3)
Local control rate
The percentage of patients without locoregional tumor recurrence 2 years after treatment
Measured: 2 years after treatment
overall survival rate
The percentage of patients that are alive 2 years after treatment
Measured: 2 years after treatment
Complete blood count
The complete blood count as assessed by a Coulter (LH 750 Haematology Analyzer)
Measured: before radiation treatment and after every 5 fraction of radiotherapy (7 time points in total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Esophageal NeoplasmsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chuangzhen Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chuangzhen Chen, Shantou University Medical College
- Investigators
- Chuangzhen Chen, MD, Principal investigator, Cancer Hospital, Shantou University Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670409
- Sponsor's protocol ID
- SUMC-ECA-001
- Other IDs
- ChiCTR-ONC-12002356
- Status last verified
- Dec 2021
- First submitted
- 12 Aug 2012
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Liu W, Zeng C, Wang S, Zhan Y, Huang R, Luo T, Peng G, Wu Y, Qiu Z, Li D, Wu F, Chen C. A combined predicting model for benign esophageal stenosis after simultaneous integrated boost in esophageal squamous cell carcinoma patients (GASTO1072). Front Oncol. 2022 Dec 22;12:1026305. doi: 10.3389/fonc.2022.1026305. eCollection 2022.
PubMed 37078004Zhang WZ, Chen JZ, Li DR, Chen ZJ, Guo H, Zhuang TT, Li DS, Zhou MZ, Chen CZ. Simultaneous modulated accelerated radiation therapy for esophageal cancer: a feasibility study. World J Gastroenterol. 2014 Oct 14;20(38):13973-80. doi: 10.3748/wjg.v20.i38.13973.
PubMed 25320535
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Simultaneous Modulated Accelerated Radiation Therapy Concurrent With Chemotherapy in Patients With Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01670409
- Acronym / sponsor ID
- SUMC-ECA-001
- Conditions
- Esophageal Neoplasms
- Keywords
- Esophageal squamous cell carcinoma, SMART, IMRT, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Chuangzhen ChenUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 22 Aug 2012 (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.
The purpose of this study is to evaluate the acute and 2-year late toxicities, the 2-year local control and overall survival rates in patients with esophageal squamous cell carcinoma receiving simultaneous modulated accelerated radiation therapy concurrent with chemotherapy.
Detailed description
Esophageal cancer is one of the most common malignant diseases in China, especially in Chaoshan region. Concurrent chemoradiotherapy is the standard non-surgical treatment method for this disease and the radiation schedule is about 50.4~60 Gray (Gy) in total, 1.8~2Gy per fraction generally. However, although with such comprehensive method, noncontrol of local disease or recurrence is still the main reason of failure.
Most patients with esophageal cancer suffer from malnutrition. A number of factors including hypoxic, inflammation, radioresistance and accelerated repopulation may contribute to local failures of disease after treatment; therefore a higher radiation biological equivalent dose (BED) will improve the local control probability. Although the intergroup 0123 (INT123) trial had shown that simply increasing total radiation dose could not gain better local control or overall survival rate, however, the ability of this trial to test the potential benefits of higher radiation dose could be compromized by the deficiencies within them, such as, observation bias,large radiated target volume and usage of conventional radiation technique. In other words, the probability that increasing radiation may help improving the control of disease should not be denied.
Modern radiation techniques, such as intensity modulation radiation therapy (IMRT), specially, are able to improve the coverage of target volumes and sparing of critical structures, while increase the total radiation dose. By using simultaneous modulated accelerated radiation therapy (SMART) technique, the doses to the relevant normal organs per fraction could be reduced significantly, while the doses to tumor could be increased to higher than 2Gy. Thus reach the double goal of protection of normal tissues, increasing total radiation Equivalent Uniform Dose (EUD). Dosimetric study has proven the feasibility and superiority of SMART-base IMRT in radiation treatment of esophageal cancer, compared with conventional technique.
Overall, SMART-base IMRT concurrent with chemotherapy may improve the local control and overall survival rate of patients with esophageal cancer; Meanwhile, the acute and late toxicities would be tolerable and slighter than that of conventional technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SMART combined with PF chemotherpay | Experimental | Radiation: SMART, Drug: PFSMART-base IMRT with concurrent and adjuvant chemotherapy(cisplatin and 5-fluorouracil) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- pathological proven diagnosis of primary squamous cell carcinoma of the esophagus
- the primary disease located in cervical, upper or middle thoracic esophagus
- no distant metastases
- zubrod performance status: 0~2
- life expectancy > 6 months; -absence of another malignancy
Key exclusion criteria (5 listed)
- evidence of tracheoesophageal or Mediastinal-esophageal fistula
- prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years
- prior radiation therapy that would result in overlap of planned radiation therapy fields; - Severe, active comorbidity
- pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
- women who are nursing
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 |
|---|---|---|
| SMARTThe PTV (planning target volume) of gross tumor will receive radiation dose of 66Gy, 2.2Gy per fraction and the PTV of subclinical disease will receive 54Gy, 1.8Gy per fraction,5 fraction per week. | Radiation | SMART combined with PF chemotherpay |
| PFAlso: cisplatin plus 5fluorouracilConcurrent and adjuvant chemotherapy: Cisplatin, 80mg/m2, intravenous on day 1, 5fluorouracil 0.5/m2, intravenous on d1 to d4. Two cycles during radiation treatment on d1 and d28. Two additional cycles after radiation treatment, 4 weeks per cycle. | Drug | SMART combined with PF chemotherpay |
Primary outcome
Toxicities
Time frame: The period during treatment and the 2 years after treatment
The probabilities of grade ≥ 3 acute toxicities and 2-year late toxicities of esophagus and lungs as assessed by CTCAE 4.0
3 secondary outcomes
Local control rate
Time frame: 2 years after treatment
overall survival rate
Time frame: 2 years after treatment
Complete blood count
Time frame: before radiation treatment and after every 5 fraction of radiotherapy (7 time points in total)
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 3 Jan 2022.
- Derived from this study: PubMed 37078004Liu W, Zeng C, Wang S, Zhan Y, Huang R, Luo T, Peng G, Wu Y, Qiu Z, Li D, Wu F, Chen C. A combined predicting model for benign esophageal stenosis after simultaneous integrated boost in esophageal squamous cell carcinoma patients (GASTO1072). Front Oncol. 2022 Dec 22;12:1026305. doi: 10.3389/fonc.2022.1026305. eCollection 2022.
- Derived from this study: PubMed 25320535Zhang WZ, Chen JZ, Li DR, Chen ZJ, Guo H, Zhuang TT, Li DS, Zhou MZ, Chen CZ. Simultaneous modulated accelerated radiation therapy for esophageal cancer: a feasibility study. World J Gastroenterol. 2014 Oct 14;20(38):13973-80. doi: 10.3748/wjg.v20.i38.13973.
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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.
Chuangzhen Chen, MD principal investigator
Cancer Hospital, Shantou University Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SMART and PF in people with Esophageal Neoplasms, run by Chuangzhen Chen 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 8 inclusion and 5 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 3 Jan 2022. 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 phase mean?
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?
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?
Toxicities (time frame: The period during treatment and the 2 years after treatment). 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 NCT01670409, which also lists 2 linked publications.
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 3 Jan 2022.