Esophageal Squamous Cell CarcinomaPhase 3NCT03273647
Adjuvant Radiotherapy for Esophageal Squamous Cell Carcinoma With Positive Circumstantial Resection Margin
A Phase 3 study testing radiation in people with Esophageal Squamous Cell Carcinoma and Positive Circumferential Resection Margin, run by Fudan University.
Trial summary
The purpose of this study is to determine the efficacy of adjuvant radiotherapy for esophageal squamous cell carcinoma with positive circumstantial resection margin. Read more about this study
- Who is it for?
- Ages 18 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma, Positive Circumferential Resection Margin
- What is being tested?
- radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2017to 1 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 18 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with esophageal cancer who received R0 operations in Fudan University Shanghai Cancer Center and postoperative pathology: squamous cell cancer,positive Circumferential Resection Margin(CRM)+
- KPS≥70 before radiotherapy;
- Did not receive neoadjuvant or adjuvant treatment;
- No clear recurrent or metastatic lesions before radiotherapy;
- Intensity modulated radiation therapy(IMRT) is accepted;
- Regular follow-up.
Who cannot join
- Exploratory thoracotomy or palliative surgery;
- No clear recurrent or metastatic sites;
- Recurrence or metastasis is not certain;
- death of no definite cause.
- Irregular follow-up;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Adjuvant Radiotherapy for T3N0M0 Esophageal Squamous Cell Carcinoma With Positive Circumstantial Resection Margin(a Randomized Controlled Trial)
The purpose of this study is to determine the efficacy of adjuvant radiotherapy for esophageal squamous cell carcinoma with positive circumstantial resection margin.
Read the detailed description
Although preoperative chemoradiation therapy followed by surgery is the most common approach for patients with resectable esophageal cancer, the considerable number of esophageal cancer patients received operation as the first treatment modality. Accordingly, postoperative treatments have been playing an important role because of the poor survival rates of the patients who have been treated with resection alone. The existing data shows that the 5-yeal survival rate of stage T2-3N0M0(UICC 7th edition) of thoracic esophageal squamous cell carcinoma(TESCC) after surgery is about 50% ,and locoregional lymph nodes metastases is responsible for the main cause of failure while distal metastases account for relatively less ratio. Therefore, the subclinical residual tumor is affirmative even if the early disease has been undergone curable excision and local adjuvant treatment may be essential. In rectal cancer, the involvement of the circumferential resection margin (CRM) is one of the key factors for local recurrence and poor prognosis,based on reports in which CRM with < 1mm was found to be prognostically significant, whereas the clinical and prognostic significance of the CRM involvement in EC has been investigated only in a few series showing conflicting results, as some studies suggest a significant influence of CRM. There is lack of clear evidence for prophylactic radiation therapy in positive Circumferential Resection Margin(CRM) patients of TESCC now. In view of this, the randomized controlled trial will determine the clinical efficacy and toxicity of adjuvant radiotherapy in positive Circumferential Resection Margin(CRM) for thoracic esophageal squamous cell carcinoma.
- Being tested
- radiation
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiationRadiation
A total dose of 40Gy will be delivered in 20 fractions at 2.0Gy/fraction, 5 fractions per week in 4 weeks.
The CTV encompassed the bilateral supraclavicular region, all mediastinal lymph nodes, the anastomosis site, and the left gastric and Celiac nodes.
| Study group | Role | What they receive |
|---|---|---|
| surgery plus radiation | Experimental | adjuvant radiotherapy is developed in this arm Receives: Radiation: radiation |
| surgery alone | No intervention | No adjuvant radiotherapy,that is surgery alone is developed in this arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival time
including survival time from randomization to locoregional recurrence and to distal metastasis
Measured: up to 3 years
Secondary outcomes (1)
overall survival time
survival time from randomization to death
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start1 Dec 2017 (estimated)
- Primary completion1 Dec 2019 (estimated)
- Study completion1 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 Squamous Cell CarcinomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiaqing Xiang, Fudan University
- Investigators
- Jiaqing Xiang, MD, Principal investigator, professor of Department of Thoracic Surgery, Fudan University Shanghai Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273647
- Sponsor's protocol ID
- ESO-CRM
- Status last verified
- Oct 2017
- First submitted
- 4 Sep 2017
- Last updated
- 19 Oct 2017
- 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 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Radiotherapy for T3N0M0 Esophageal Squamous Cell Carcinoma With Positive Circumstantial Resection Margin(a Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT03273647
- Acronym / sponsor ID
- ESO-CRM
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 6 Sep 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 purpose of this study is to determine the efficacy of adjuvant radiotherapy for esophageal squamous cell carcinoma with positive circumstantial resection margin.
Detailed description
Although preoperative chemoradiation therapy followed by surgery is the most common approach for patients with resectable esophageal cancer, the considerable number of esophageal cancer patients received operation as the first treatment modality. Accordingly, postoperative treatments have been playing an important role because of the poor survival rates of the patients who have been treated with resection alone. The existing data shows that the 5-yeal survival rate of stage T2-3N0M0(UICC 7th edition) of thoracic esophageal squamous cell carcinoma(TESCC) after surgery is about 50% ,and locoregional lymph nodes metastases is responsible for the main cause of failure while distal metastases account for relatively less ratio. Therefore, the subclinical residual tumor is affirmative even if the early disease has been undergone curable excision and local adjuvant treatment may be essential. In rectal cancer, the involvement of the circumferential resection margin (CRM) is one of the key factors for local recurrence and poor prognosis,based on reports in which CRM with < 1mm was found to be prognostically significant, whereas the clinical and prognostic significance of the CRM involvement in EC has been investigated only in a few series showing conflicting results, as some studies suggest a significant influence of CRM. There is lack of clear evidence for prophylactic radiation therapy in positive Circumferential Resection Margin(CRM) patients of TESCC now. In view of this, the randomized controlled trial will determine the clinical efficacy and toxicity of adjuvant radiotherapy in positive Circumferential Resection Margin(CRM) for thoracic esophageal squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery plus radiation | Experimental | Radiation: radiationadjuvant radiotherapy is developed in this arm |
| surgery alone | No intervention | –No adjuvant radiotherapy,that is surgery alone is developed in this arm |
Who may qualify
- Ages
- 18 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients with esophageal cancer who received R0 operations in Fudan University Shanghai Cancer Center and postoperative pathology: squamous cell cancer,positive Circumferential Resection Margin(CRM)+
- KPS≥70 before radiotherapy;
- Did not receive neoadjuvant or adjuvant treatment;
- No clear recurrent or metastatic lesions before radiotherapy;
- Intensity modulated radiation therapy(IMRT) is accepted;
Key exclusion criteria (5 listed)
- Exploratory thoracotomy or palliative surgery;
- No clear recurrent or metastatic sites;
- Recurrence or metastasis is not certain;
- death of no definite cause.
- Irregular follow-up;
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 |
|---|---|---|
| radiationA total dose of 40Gy will be delivered in 20 fractions at 2.0Gy/fraction, 5 fractions per week in 4 weeks. The CTV encompassed the bilateral supraclavicular region, all mediastinal lymph nodes, the anastomosis site, and the left gastric and Celiac nodes. | Radiation | surgery plus radiation |
Primary outcome
Disease-free survival time
Time frame: up to 3 years
including survival time from randomization to locoregional recurrence and to distal metastasis
1 secondary outcome
overall survival time
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
- Individual participant dataSharing planned: No
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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.
Jiaqing Xiang, MD principal investigator
professor of Department of Thoracic Surgery, Fudan University Shanghai Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing radiation in people with Esophageal Squamous Cell Carcinoma and Positive Circumferential Resection Margin, run by Fudan University.
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 6 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: status not confirmed, as of the sponsor's last update on 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Jiaqing Xiang, MD (+86 13901992249, j.q.xiang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival time (time frame: up to 3 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 19 Oct 2017.