Esophageal CancerPhase 3SUMC-EC-002NCT02556762
Simultaneous Modulated Accelerated Boost Versus Standard Dose Radiotherapy in Esophageal Cancer
A Phase 3 study testing Radiotherapy with simultaneous modulated accelerated boost, Standard dose radiotherapy and PF in people with Esophageal Cancer, run by Chuangzhen Chen at 1 site in China.
Trial summary
This randomized phase III trial is to compare simultaneous modulated accelerated boost with standard dose radiotherapy given together with chemotherapy in treating patients with esophageal squamous cell carcinoma. 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 with simultaneous modulated accelerated boost, Standard dose radiotherapy and PF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteChina
- Study dates
- Aug 2015to 31 Dec 2024
- Phase
- Phase 3
- 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
- Histologic proof of primary squamous cell carcinoma of the esophagus.
- Primary disease at cervical, upper or middle thoracic esophagus
- T1-4, N any, M0 (except supraclavicular lymph node).
- Age≥18 \& ≤75.
- ECOG score 0-2.
- Platelets ≥ 150,000, Hgb ≥ 10 gm%, ANC ≥ 1500, serum creatinine ≤ 1.5 mg/dl.
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- Adequate liver function.
- Patients with prior malignancy are eligible if disease-free ≥ 5 years.
- No prior chest radiotherapy, systemic chemotherapy or major esophageal surgery.
- Signed study-specific informed consent form prior to study entry.
Who cannot join
- Patients with tracheo-esophageal fistula.
- Patients with invasion into mucosa of trachea or major bronchi.
- Patients with uncontrolled serious medical or mental illnesses.
- Prior RT that would result in overlap of planned RT fields.
- Pregnancy or women of childbearing potential and men who are sexually active
- Women who are breastfeeding a baby.
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: Phase III Randomized Controlled Trial of Definite Chemoradiotherapy in Patients With Esophageal Cancer: Simultaneous Modulated Accelerated Boost Versus Standard Dose Radiotherapy
This randomized phase III trial is to compare simultaneous modulated accelerated boost with standard dose radiotherapy given together with chemotherapy in treating patients with esophageal squamous cell carcinoma.
- Conditions
- Esophageal Cancer
- Being tested
- Radiotherapy with simultaneous modulated accelerated boost, Standard dose radiotherapy, PF
- Keywords
- Esophageal cancer, Simultaneous modulated accelerated boost, Standard dose radiotherapy, Chemotherapy, Survival
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy with simultaneous modulated accelerated boostRadiation
Also called SIB
Radiotherapy: 66Gy/30F to the gross tumor and 50Gy/25 to subclinical diseases
Standard dose radiotherapyRadiation
Radiotherapy: 50Gy/25F to both gross tumor and subclinical disease
PFDrug
Chemotherapy: Cisplatin and 5fluorouracil
| Study group | Role | What they receive |
|---|---|---|
| SMART boost | Experimental | Radiotherapy with simultaneous modulated accelerated boost Receives: Radiation: Radiotherapy with simultaneous modulated accelerated boost; Drug: PF |
| Standard dose RT | Active comparator | Standard dose radiotherapy Receives: Radiation: Standard dose radiotherapy; Drug: PF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 2 years
Secondary outcomes (7)
Local-regional control
Measured: 2 years
Distant metastasis-free survival
Measured: 2 years
Disease-free survival
Measured: 2 years after randomization
Acute and late toxicities using CTCAE v4.0
The probabilities of grade ≥ 3 acute toxicities and 2-year late toxicities of esophagus and lungs.
Measured: 2 years
Quality of life as assessed with FACT-E
FACT-E score
Measured: 2 years
Quality of life as measured with EQ-5D
The score of EQ-5D questionnaire
Measured: 2 years
Biomarkers
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 posted22 Sep 2015 (estimated)
- Study startAug 2015
- Primary completion1 Mar 2022
- Study completion31 Dec 2024 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 202 participants (estimated)
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
- NCT02556762
- Sponsor's protocol ID
- SUMC-EC-002
- Acronym
- SUMC-EC-002
- Status last verified
- Feb 2024
- First submitted
- 17 Sep 2015
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Controlled Trial of Definite Chemoradiotherapy in Patients With Esophageal Cancer: Simultaneous Modulated Accelerated Boost Versus Standard Dose Radiotherapy
- ClinicalTrials.gov ID
- NCT02556762
- Acronym / sponsor ID
- SUMC-EC-002 / SUMC-EC-002
- Conditions
- Esophageal Cancer
- Keywords
- Esophageal cancer, Simultaneous modulated accelerated boost, Standard dose radiotherapy, Chemotherapy, Survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Chuangzhen ChenUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Sep 2015 (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.
This randomized phase III trial is to compare simultaneous modulated accelerated boost with standard dose radiotherapy given together with chemotherapy in treating patients with esophageal squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMART boost | Experimental | Radiation: Radiotherapy with simultaneous modulated accelerated boost, Drug: PFRadiotherapy with simultaneous modulated accelerated boost |
| Standard dose RT | Active comparator | Radiation: Standard dose radiotherapy, Drug: PFStandard dose radiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologic proof of primary squamous cell carcinoma of the esophagus.
- Primary disease at cervical, upper or middle thoracic esophagus
- T1-4, N any, M0 (except supraclavicular lymph node).
- Age≥18 \& ≤75.
- ECOG score 0-2.
Key exclusion criteria (6 listed)
- Patients with tracheo-esophageal fistula.
- Patients with invasion into mucosa of trachea or major bronchi.
- Patients with uncontrolled serious medical or mental illnesses.
- Prior RT that would result in overlap of planned RT fields.
- Pregnancy or women of childbearing potential and men who are sexually active
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 |
|---|---|---|
| Radiotherapy with simultaneous modulated accelerated boostAlso: SIBRadiotherapy: 66Gy/30F to the gross tumor and 50Gy/25 to subclinical diseases | Radiation | SMART boost |
| Standard dose radiotherapyRadiotherapy: 50Gy/25F to both gross tumor and subclinical disease | Radiation | Standard dose RT |
| PFChemotherapy: Cisplatin and 5fluorouracil | Drug | SMART boost, Standard dose RT |
Primary outcome
Overall survival
Time frame: 2 years
7 secondary outcomes
Local-regional control
Time frame: 2 years
Distant metastasis-free survival
Time frame: 2 years
Disease-free survival
Time frame: 2 years after randomization
Acute and late toxicities using CTCAE v4.0
Time frame: 2 years
Quality of life as assessed with FACT-E
Time frame: 2 years
Quality of life as measured with EQ-5D
Time frame: 2 years
Biomarkers
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
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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 3 study testing Radiotherapy with simultaneous modulated accelerated boost, Standard dose radiotherapy and PF in people with Esophageal Cancer, 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 10 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: status not confirmed, as of the sponsor's last update on 6 Feb 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
Overall survival (time frame: 2 years). 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 6 Feb 2024.