Esophageal Squamous Cell CarcinomaPhase 2NCT02384811
Phase II Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy for Esophageal Squamous Cell Carcinoma
A Phase 2 study testing radiation in people with Esophageal Squamous Cell Carcinoma, run by Fudan University at 2 sites in China.
Trial summary
The primary object of this trial is to evaluate the 2-year local control rate adding extensive clinical target volumes in postoperative radiotherapy for esophageal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- 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
- 70 participants
- Where
- 2 sitesChina
- Study dates
- Dec 2014to Jul 2019
- 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
- Joined the study voluntarily and signed informed consent form;
- Age 18-75；ECOG 0-2
- Esophageal squamous cell carcinoma , radical surgery ≤3 months,R0 resection. The operative incision healed well.
- T3-4N0M0, T1-4N1-3M0 (according to AJCC2009)
- No radiotherapy, chemotherapy or other treatments pre(post)surgery
- PS ECOG 0-2
Show all 10Show fewer
- Life expectancy of more than 3 months
- Hemoglobin(Hb)≥9 g/dL • WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L • platelet count (Pt) ≥100x 109/L • Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL<1.5 x ULN • Renal function: creatinine < 1.5 x ULN
- No immuno-deficiency
- Use of an effective contraceptive for adults to prevent pregnancy.
Who cannot join
- Complete esophageal obstruction after surgery, Esophageal perforation, Haematemesis
- Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years
- Participation in other interventional clinical trials within 30 days
- Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
- Drug addiction, Alcoholism or AIDS
- Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
- Unsuitable to be enrolled in the trial in the opinion of the investigators
Trial locations and contacts
2 sites in 1 country.
China2 sites
Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000
Cancer hospital Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Phase II Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy for Esophageal
The primary object of this trial is to evaluate the 2-year local control rate adding extensive clinical target volumes in postoperative radiotherapy for esophageal squamous cell carcinoma.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- radiation
- Keywords
- Esophageal squamous cell carcinoma, postoperative radiotherapy
- 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 |
|---|---|---|
| Radiation group | Experimental | Radiation therapy Receives: Radiation: radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control rate
Measured: 2 years
Secondary outcomes (2)
Overall survival
Measured: 5 year
Safety: Frequencies of treatment-related adverse event categories by NCI-CTC
Frequencies of treatment-related adverse event categories by NCI-CTC including Esophagitis,Pneumonitis/Bronchitis,Skin reaction in radiation fields,Nausea/vomiting,Leucopenia,Thrombocytopenia,Anemia,Fatigue.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startDec 2014
- Primary completionJul 2017
- Study completionJul 2019 (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 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiaqing Xiang, Fudan University
- Investigators
- Jia-qing Xiang, M.M, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384811
- Sponsor's protocol ID
- 2014-86-882
- Status last verified
- Sep 2017
- First submitted
- 2 Mar 2015
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang X, Ai D, Wang J, Chen Y, Liu Q, Deng J, Yang H, Nie Y, Chen W, Zhao W, Zhao K. The Prognosis and Feasibility of Extensive Clinical Target Volume in Postoperative Radiotherapy for Esophageal Squamous Cell Carcinoma: A Phase II Clinical Trial. Front Oncol. 2021 Jul 2;11:669575. doi: 10.3389/fonc.2021.669575. eCollection 2021.
PubMed 34295813
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy for Esophageal
- ClinicalTrials.gov ID
- NCT02384811
- Acronym / sponsor ID
- 2014-86-882
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- Esophageal squamous cell carcinoma, postoperative radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2019 (estimated)
- First posted
- 10 Mar 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.
The primary object of this trial is to evaluate the 2-year local control rate adding extensive clinical target volumes in postoperative radiotherapy for esophageal squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation group | Experimental | Radiation: radiationRadiation therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Joined the study voluntarily and signed informed consent form;
- Age 18-75；ECOG 0-2
- Esophageal squamous cell carcinoma , radical surgery ≤3 months,R0 resection. The operative incision healed well.
- T3-4N0M0, T1-4N1-3M0 (according to AJCC2009)
- No radiotherapy, chemotherapy or other treatments pre(post)surgery
Key exclusion criteria (7 listed)
- Complete esophageal obstruction after surgery, Esophageal perforation, Haematemesis
- Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years
- Participation in other interventional clinical trials within 30 days
- Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
- Drug addiction, Alcoholism or AIDS
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 | Radiation group |
Primary outcome
Local control rate
Time frame: 2 years
2 secondary outcomes
Overall survival
Time frame: 5 year
Safety: Frequencies of treatment-related adverse event categories by NCI-CTC
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
- Derived from this study: PubMed 34295813Zhang X, Ai D, Wang J, Chen Y, Liu Q, Deng J, Yang H, Nie Y, Chen W, Zhao W, Zhao K. The Prognosis and Feasibility of Extensive Clinical Target Volume in Postoperative Radiotherapy for Esophageal Squamous Cell Carcinoma: A Phase II Clinical Trial. Front Oncol. 2021 Jul 2;11:669575. doi: 10.3389/fonc.2021.669575. eCollection 2021.
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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.
Jia-qing Xiang, M.M principal investigator
Fudan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing radiation in people with Esophageal Squamous Cell Carcinoma, run by Fudan University at 2 sites 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 7 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 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Local control rate (time frame: 2 years). 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 NCT02384811, 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 7 Sep 2017.