Stage II Esophageal CancerPhase 2NCT02959385
A Phase II Trial to Compare Efficacy and Safety of CRT VS Neo-CRT in Patients Who Achieved CCR for Esophageal Cancer
A Phase 2 study testing Definitive Radiochemotherapy and Neoadjuvant Radiochemotherapy in people with Stage II Esophageal Cancer and Stage III Esophageal Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
Neoadjuvant chemoradiotherapy(Neo-CRT) plus surgery has been regarded as a standard of care for patients with resectable locally advanced oesophageal cancer. Many studies suggest that definitive Radiochemotherapy(CRT) has similar efficacy as neoadjuvant chemoradiotherapy plus surgery for esophageal cancers who respond… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stage II Esophageal Cancer, Stage III Esophageal Cancer
- What is being tested?
- Definitive Radiochemotherapy and Neoadjuvant Radiochemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Sep 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Thoracic esophageal cancer patients or esophagocardial cancer patients, with locally advanced resectable tumor, clinically identified before treatment as T1-3N+M0 according to UICC(International Union Against Cancer) TNM(primary tumor, regional nodes, metastasis) Classification of Malignant Tumours, 7th ed.
- Untreated patients who have not received any antitumor therapy
- Life expectancy >6 months
- Age: 18-70 years
- White blood cell count ≥4.0×109/l, ANC(absolute neutrophil count) ≥1.5×109/l, thrombocyte count ≥1011/l, hemoglobin ≥90 g/l; normal liver and kidney functions
- WHO PS(Performance Status): 0-1
- Patients who understood the study and gave signed informed consent
Who cannot join
- Patients who have already received antitumor therapy, including chemotherapy, radiotherapy or surgery;
- Patients with hemorrhage or complicated hemorrhage
- Other uncontrollable patients who are not suitable for surgery
- Pregnant or lactating women
- Patients who agree without acknowledgement as a result of psychological, family or social factors
- Patients with CTCAE(Common Terminology Criteria Adverse Events Version 4.0) grade ≥2 peripheral neuropathy
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- Patients who have ever had malignant tumors other than esophageal cancer
- Patients with a history of diabetes for >10 years with unsatisfactory control of blood glucose level
- Patients with serious heart, lung, liver or kidney dysfunction, hematopathy, immune system disease or cachexia who therefore cannot tolerate chemotherapy or surgery
- Others.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Radiation Oncology, Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, 300060
QING SONG PANG, M.D, +86-22-23340123-1314, pangqingsong@yahoo.com.cn
About this study
Official title: A Phase II Trial to Compare Efficacy and Safety of Definitive Radiochemotherapy VS Neoadjuvant Radiochemotherapy Plus Surgery in Patients Who Achieved Clinical Complete Response After Neoadjuvant Treatment for Stage II-III Esophageal Cancer
Neoadjuvant chemoradiotherapy(Neo-CRT) plus surgery has been regarded as a standard of care for patients with resectable locally advanced oesophageal cancer. Many studies suggest that definitive Radiochemotherapy(CRT) has similar efficacy as neoadjuvant chemoradiotherapy plus surgery for esophageal cancers who respond to chemoradiation. Herein, a single center prospective randomized phase II clinical trial will be carried out to compare efficacy and safety of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection in patients who achieved clinical complete response(CCR) after neoadjuvant radiochemotherapy for stage II-III esophageal Cancer.
Read the detailed description
- Compare progression-free survival (PFS) and overall survival (OS) of definitive radiochemotherapy versus(VS) neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who achieved clinical complete response after neoadjuvant treatment;
- Compare the toxic and side effects of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who achieved clinical complete remission after neoadjuvant treatment;
- Compare the relationship and consistency between pathological complete response of endoscopic biopsy specimens after neoadjuvant treatment and pathological complete response of surgical specimens in neoadjuvant radiochemotherapy plus radical resection group;
- Assess impact of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection on quality of life of patients.
Clinical Complete Response After Neoadjuvant Treatment: Endoscope biopsy pathologic diagnosis indicate pathologic complete response after Neoadjuvant treatment; upper gastrointestinal/chest CT and symptom assessment indicate clinical complete response after Neoadjuvant treatment (Concurrent Radiochemotherapy: Radiotherapy, Intensity Modulation Radiation Therapy(IMRT), 40Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2), 1st/8th/15th/22nd day
- Being tested
- Definitive Radiochemotherapy, Neoadjuvant Radiochemotherapy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Definitive RadiochemotherapyRadiation
Radiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day
Neoadjuvant RadiochemotherapyProcedure or surgery
Concurrent Radiochemotherapy: Radiotherapy,IMRT, 40Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day; Receive radical surgery 4 to 6 weeks later.
| Study group | Role | What they receive |
|---|---|---|
| Definitive Radiochemotherapy | Experimental | Concurrent Radiochemotherapy:
Radiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day. Receives: Radiation: Definitive Radiochemotherapy; Procedure: Neoadjuvant Radiochemotherapy |
| Neoadjuvant Radiochemotherapy | Active comparator | Concurrent Radiochemotherapy:
Radiotherapy,IMRT, 40Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day; Receive radical surgery 4 to 6 weeks later. Receives: Radiation: Definitive Radiochemotherapy; Procedure: Neoadjuvant Radiochemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Compare overall survival of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who achieved clinical complete response after neoadjuvant radiochemotherapy
Measured: 5 years
Secondary outcomes (5)
Progression-free survival
Compare progression-free survival of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who achieved clinical complete response after neoadjuvant radiochemotherapy.
Measured: 3 years
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
grade 3 or 4 toxicity of leukocytes, febrile neutropenia, thrombocytes, hemoglobin, nausea/vomiting, diarrhea, stomatitis, esophagitis, cardiovascular.
Measured: 5 years
Comparison of pathological diagnosis between specimens of endoscopic biopsy and surgically resected in esophageal cancer
In the group of neoadjuvant radiochemotherapy plus surgery, we will compare the pathological diagnosis between specimens of endoscopic biopsy after neoadjuvant treatment and surgically resected.
Measured: 2 years
Comparison between gross tumor volume (GTV) delineated with ultrasonic endoscopically placed titanium clips and GTV with conventional contouring method in thoracic esophageal cancer
patients undergo titanium clips placement on tumor boundaries under ultrasonic endoscopy before radiotherapy CT simulation. According to the clips, the reference GTVs are contoured by one experienced radiation oncologist. With the help of Eclipse treatment planning system, clips on CT are concealed. Two other radiation oncologists of expertise in oesophageal cancer delineate GTVs, defined as conventional GTVs, on the basis of endoscopy and oesophageal barium radiography. The two sets of GTVs are compared and analysed.
Measured: 1 year
Determination of internal target volume (ITV) of thoracic esophageal cancer by evaluating movement of ultrasonic endoscopically placed titanium clips, with or without swallowing, during radiotherapy simulation
after titanium clips placement adjacent to esophageal cancer under ultrasonic endoscopy, clips movements in different borders and different directions are observed during radiotherapy simulation to determine the ITV of esophageal cancer, with or without swallowing.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2018 (estimated)
- Study completionSep 2021 (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 Stage II Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qingsong Pang, Doctor, Study chair, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959385
- Sponsor's protocol ID
- CIH-PQS-2016090001
- Status last verified
- Oct 2016
- First submitted
- 29 Oct 2016
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Qian D, Chen X, Shang X, Wang Y, Tang P, Han D, Jiang H, Chen C, Zhao G, Zhou D, Cao F, Er P, Zhang W, Li X, Zhang T, Zhang B, Guan Y, Wang J, Yuan Z, Yu Z, Wang P, Pang Q. Definitive chemoradiotherapy versus neoadjuvant chemoradiotherapy followed by surgery in patients with locally advanced esophageal squamous cell carcinoma who achieved clinical complete response when induction chemoradiation finished: A phase II random. Radiother Oncol. 2022 Sep;174:1-7. doi: 10.1016/j.radonc.2022.06.015. Epub 2022 Jun 25.
PubMed 35764191
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial to Compare Efficacy and Safety of Definitive Radiochemotherapy VS Neoadjuvant Radiochemotherapy Plus Surgery in Patients Who Achieved Clinical Complete Response After Neoadjuvant Treatment for Stage II-III Esophageal Cancer
- ClinicalTrials.gov ID
- NCT02959385
- Acronym / sponsor ID
- CIH-PQS-2016090001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 9 Nov 2016 (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.
Neoadjuvant chemoradiotherapy(Neo-CRT) plus surgery has been regarded as a standard of care for patients with resectable locally advanced oesophageal cancer. Many studies suggest that definitive Radiochemotherapy(CRT) has similar efficacy as neoadjuvant chemoradiotherapy plus surgery for esophageal cancers who respond to chemoradiation. Herein, a single center prospective randomized phase II clinical trial will be carried out to compare efficacy and safety of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection in patients who achieved clinical complete response(CCR) after neoadjuvant radiochemotherapy for stage II-III esophageal Cancer.
Detailed description
- Compare progression-free survival (PFS) and overall survival (OS) of definitive radiochemotherapy versus(VS) neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who achieved clinical complete response after neoadjuvant treatment;
- Compare the toxic and side effects of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who achieved clinical complete remission after neoadjuvant treatment;
- Compare the relationship and consistency between pathological complete response of endoscopic biopsy specimens after neoadjuvant treatment and pathological complete response of surgical specimens in neoadjuvant radiochemotherapy plus radical resection group;
- Assess impact of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection on quality of life of patients.
Clinical Complete Response After Neoadjuvant Treatment: Endoscope biopsy pathologic diagnosis indicate pathologic complete response after Neoadjuvant treatment; upper gastrointestinal/chest CT and symptom assessment indicate clinical complete response after Neoadjuvant treatment (Concurrent Radiochemotherapy: Radiotherapy, Intensity Modulation Radiation Therapy(IMRT), 40Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2), 1st/8th/15th/22nd day
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Definitive Radiochemotherapy | Experimental | Radiation: Definitive Radiochemotherapy, Procedure: Neoadjuvant RadiochemotherapyConcurrent Radiochemotherapy: Radiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day. |
| Neoadjuvant Radiochemotherapy | Active comparator | Radiation: Definitive Radiochemotherapy, Procedure: Neoadjuvant RadiochemotherapyConcurrent Radiochemotherapy: Radiotherapy,IMRT, 40Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day; Receive radical surgery 4 to 6 weeks later. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Thoracic esophageal cancer patients or esophagocardial cancer patients, with locally advanced resectable tumor, clinically identified before treatment as T1-3N+M0 according to UICC(International Union Against Cancer) TNM(primary tumor, regional nodes, metastasis) Classification of Malignant Tumours, 7th ed.
- Untreated patients who have not received any antitumor therapy
- Life expectancy >6 months
- Age: 18-70 years
- White blood cell count ≥4.0×109/l, ANC(absolute neutrophil count) ≥1.5×109/l, thrombocyte count ≥1011/l, hemoglobin ≥90 g/l; normal liver and kidney functions
Key exclusion criteria (10 listed)
- Patients who have already received antitumor therapy, including chemotherapy, radiotherapy or surgery;
- Patients with hemorrhage or complicated hemorrhage
- Other uncontrollable patients who are not suitable for surgery
- Pregnant or lactating women
- Patients who agree without acknowledgement as a result of psychological, family or social factors
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 |
|---|---|---|
| Definitive RadiochemotherapyRadiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day | Radiation | Definitive Radiochemotherapy, Neoadjuvant Radiochemotherapy |
| Neoadjuvant RadiochemotherapyConcurrent Radiochemotherapy: Radiotherapy,IMRT, 40Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day; Receive radical surgery 4 to 6 weeks later. | Procedure or surgery | Definitive Radiochemotherapy, Neoadjuvant Radiochemotherapy |
Primary outcome
Overall survival
Time frame: 5 years
Compare overall survival of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who achieved clinical complete response after neoadjuvant radiochemotherapy
5 secondary outcomes
Progression-free survival
Time frame: 3 years
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time frame: 5 years
Comparison of pathological diagnosis between specimens of endoscopic biopsy and surgically resected in esophageal cancer
Time frame: 2 years
Comparison between gross tumor volume (GTV) delineated with ultrasonic endoscopically placed titanium clips and GTV with conventional contouring method in thoracic esophageal cancer
Time frame: 1 year
Determination of internal target volume (ITV) of thoracic esophageal cancer by evaluating movement of ultrasonic endoscopically placed titanium clips, with or without swallowing, during radiotherapy simulation
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
- Derived from this study: PubMed 35764191Qian D, Chen X, Shang X, Wang Y, Tang P, Han D, Jiang H, Chen C, Zhao G, Zhou D, Cao F, Er P, Zhang W, Li X, Zhang T, Zhang B, Guan Y, Wang J, Yuan Z, Yu Z, Wang P, Pang Q. Definitive chemoradiotherapy versus neoadjuvant chemoradiotherapy followed by surgery in patients with locally advanced esophageal squamous cell carcinoma who achieved clinical complete response when induction chemoradiation finished: A phase II random. Radiother Oncol. 2022 Sep;174:1-7. doi: 10.1016/j.radonc.2022.06.015. Epub 2022 Jun 25.
- 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.
Qingsong Pang, Doctor study chair
Tianjin Medical University Cancer Institute and Hospital
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 Definitive Radiochemotherapy and Neoadjuvant Radiochemotherapy in people with Stage II Esophageal Cancer and Stage III Esophageal Cancer, run by Tianjin Medical University Cancer Institute and Hospital 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 7 inclusion and 10 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 18 Jul 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong Qian, Doctor (+862223341405, qiankeyu1984@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 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 NCT02959385, 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 18 Jul 2017.