Esophageal CancerPhase 2NCT02938195
Phase II Study of Neo-adjuvant Chemoradiotherapy for Squamous Cell Esophageal Cancer
A Phase 2 study testing radiotherapy and Surgery in people with Esophageal Cancer and Chemoradiation, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
The investigators designed a new preoperative chemoradiotherapy regimen to focus on the most important radiation area and hope to reduce the radiation volume and try to reduce the postoperative mortality and treatment-related mortality. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal Cancer, Chemoradiation, Surgery
- What is being tested?
- radiotherapy and Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Jan 2018
- 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
- Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage IIB or III, which is potentially resectable.
- Patients must not have received any prior anticancer therapy.
- More than 6 months of expected survival.
- Age ranges from 18 to 70 years.
- Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney.
- Karnofsky performance status (KPS) of 90 or more.
- Signed informed consent document on file.
Who cannot join
- Patients are diagnosed or suspected to be allergic to cisplatin or 5-Fu.
- Patients with concomitant hemorrhagic disease.
- Pregnant or breast feeding.
- Inability to use gastric conduit after esophagectomy because of a prior surgery.
- Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more.
- Have a prior malignancy other than esophageal carcinoma, carcinoma in situ of the cervix, nonmelanoma skin cancer or cured early stage of prostate cancer.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Jun Liu, Doctor, +862122200000 ext. 3602, drjunliu@qq.com
About this study
Official title: Phase II Study of Optimum Design of Neo-adjuvant Chemoradiotherapy Followed by Surgery for Squamous Cell Esophageal Cancer
The investigators designed a new preoperative chemoradiotherapy regimen to focus on the most important radiation area and hope to reduce the radiation volume and try to reduce the postoperative mortality and treatment-related mortality.
Read the detailed description
Esophageal cancer (EC) is the eighth most common cancers in the world, with more than 480,000 new cases and 400,000 deaths occurred annually worldwide. In China, either new cases or deaths account for more than half of the world. Morever, over 90% of Chinese patients have esophageal squamous cell carcinoma (ESCC).
Surgery is the main treatment of this disease, but the prognosis of patients with locally advanced esophageal cancer is rather poor. As a result of surgery alone, the 5-year survival rate of about 25% has not changed significantly in several decades.
Neo-adjuvant chemoradiotherapy followed by surgery seems hopeful to improve the survival of EC. Recently, the CROSS trial has demonstrated that preoperative chemoradiotherapy can significantly increased the overall survival of patients with EC compared with surgery alone. However,a recent meta-analysis has indicated that an increased risk of postoperative mortality and treatment-related mortality was apparent in ESCC with the treatment of neo-adjuvant chemoradiotherapy.
Compare to surgery alone,the advantage of neoadjuvant chemoradiotherapy is reflected in the significantly higher percentage of R0 resections and higher rate of pathological complete response.
Thus,the investigators designed a new preoperative chemoradiotherapy regimen to focus on the most important radiation area and hope to reduce the radiation volume and try to reduce the postoperative mortality and treatment-related mortality.
Radiotherapy:Patients will be conducted CT simulation, and three-dimensional radiation therapy or Intensity-modulated radiation therapy was performed. 1.8Gy/fraction, 5 fractions a week, with a total dose of 4140cgy will be delivered for all patients by 6-MV-X-ray of linear accelerator.
Chemotherapy:Patients will be concurrently administered with irradiation every 4 weeks with PF regimen (cis-platinum of 25 mg/m2/d, d1-3; 5-fluorouracil of 500mg/m2/d, d1-4) for 2 cycles.
Surgery:Patients will receive operation 4-8 weeks after chemoradiotherapy.
- Conditions
- Esophageal Cancer, Chemoradiation, Surgery
- Being tested
- radiotherapy, Surgery
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapyRadiation
The clinical target volume of radiotherapy only includes the visible tumor and lymph nodes and the investigators wouldn't do any prophylactic radiation treatment.
SurgeryProcedure or surgery
Surgery would be done 4-8 weeks after neoadjuvant chemoradiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| experimental arm | Experimental | PF regimen (cis-platinum of 25 mg/m2/d, d1-3; 5-fluorouracil of 500mg/m2/d, d1-4) every 4 weeks for 2 cycles concurrently with three-dimensional radiation therapy or intensity-modulated radiotherapy followed by surgery 4-8weeks after neoadjuvant therapy in a standard manner. Receives: Radiation: radiotherapy; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients completing adjuvant chemoradiotherapy and surgery
Measured: 4-8weeks after surgery
Secondary outcomes (2)
Percentage of R0 resection
Measured: 4-8weeks after surgery
Percentage of pathological complete response
Measured: 4-8weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Chest 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Liu, Shanghai Chest Hospital
- Investigators
- Xiaolong Fu, Ph.D, Study director, Department of Radiation Oncology,Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938195
- Sponsor's protocol ID
- SCHEC001
- Status last verified
- Oct 2016
- First submitted
- 15 Oct 2016
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Shapiro J, van Lanschot JJB, Hulshof MCCM, van Hagen P, van Berge Henegouwen MI, Wijnhoven BPL, van Laarhoven HWM, Nieuwenhuijzen GAP, Hospers GAP, Bonenkamp JJ, Cuesta MA, Blaisse RJB, Busch ORC, Ten Kate FJW, Creemers GM, Punt CJA, Plukker JTM, Verheul HMW, Bilgen EJS, van Dekken H, van der Sangen MJC, Rozema T, Biermann K, Beukema JC, Piet AHM, van Rij CM, Reinders JG, Tilanus HW, Steyerberg EW, van der Gaast A; CROSS study group. Neoadjuvant chemoradiotherapy plus surgery versus surgery alone for oesophageal or junctional cancer (CROSS): long-term results of a randomised controlled trial. Lancet Oncol. 2015 Sep;16(9):1090-1098. doi: 10.1016/S1470-2045(15)00040-6. Epub 2015 Aug 5.
PubMed 26254683van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. doi: 10.1056/NEJMoa1112088.
PubMed 22646630Huang TC, Hsu CH, Lin CC, Tu YK. Systematic review and network meta-analysis: neoadjuvant chemoradiotherapy for locoregional esophageal cancer. Jpn J Clin Oncol. 2015 Nov;45(11):1023-8. doi: 10.1093/jjco/hyv119. Epub 2015 Aug 5.
PubMed 26246479Martinek J, Akiyama JI, Vackova Z, Furnari M, Savarino E, Weijs TJ, Valitova E, van der Horst S, Ruurda JP, Goense L, Triadafilopoulos G. Current treatment options for esophageal diseases. Ann N Y Acad Sci. 2016 Oct;1381(1):139-151. doi: 10.1111/nyas.13146. Epub 2016 Jul 8.
PubMed 27391867Ikebe M, Morita M, Yamamoto M, Toh Y. Neoadjuvant therapy for advanced esophageal cancer: the impact on surgical management. Gen Thorac Cardiovasc Surg. 2016 Jul;64(7):386-94. doi: 10.1007/s11748-016-0655-y. Epub 2016 May 10.
PubMed 27165288Purwar P, Bambarkar S, Jiwnani S, Karimundackal G, Laskar SG, Pramesh CS. Multimodality management of esophageal cancer. Indian J Surg. 2014 Dec;76(6):494-503. doi: 10.1007/s12262-014-1163-x. Epub 2014 Sep 11.
PubMed 25614726Kumagai K, Rouvelas I, Tsai JA, Mariosa D, Klevebro F, Lindblad M, Ye W, Lundell L, Nilsson M. Meta-analysis of postoperative morbidity and perioperative mortality in patients receiving neoadjuvant chemotherapy or chemoradiotherapy for resectable oesophageal and gastro-oesophageal junctional cancers. Br J Surg. 2014 Mar;101(4):321-38. doi: 10.1002/bjs.9418. Epub 2014 Feb 3.
PubMed 24493117
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Optimum Design of Neo-adjuvant Chemoradiotherapy Followed by Surgery for Squamous Cell Esophageal Cancer
- ClinicalTrials.gov ID
- NCT02938195
- Acronym / sponsor ID
- SCHEC001
- Conditions
- Esophageal Cancer, Chemoradiation, Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 19 Oct 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.
The investigators designed a new preoperative chemoradiotherapy regimen to focus on the most important radiation area and hope to reduce the radiation volume and try to reduce the postoperative mortality and treatment-related mortality.
Detailed description
Esophageal cancer (EC) is the eighth most common cancers in the world, with more than 480,000 new cases and 400,000 deaths occurred annually worldwide. In China, either new cases or deaths account for more than half of the world. Morever, over 90% of Chinese patients have esophageal squamous cell carcinoma (ESCC).
Surgery is the main treatment of this disease, but the prognosis of patients with locally advanced esophageal cancer is rather poor. As a result of surgery alone, the 5-year survival rate of about 25% has not changed significantly in several decades.
Neo-adjuvant chemoradiotherapy followed by surgery seems hopeful to improve the survival of EC. Recently, the CROSS trial has demonstrated that preoperative chemoradiotherapy can significantly increased the overall survival of patients with EC compared with surgery alone. However,a recent meta-analysis has indicated that an increased risk of postoperative mortality and treatment-related mortality was apparent in ESCC with the treatment of neo-adjuvant chemoradiotherapy.
Compare to surgery alone,the advantage of neoadjuvant chemoradiotherapy is reflected in the significantly higher percentage of R0 resections and higher rate of pathological complete response.
Thus,the investigators designed a new preoperative chemoradiotherapy regimen to focus on the most important radiation area and hope to reduce the radiation volume and try to reduce the postoperative mortality and treatment-related mortality.
Radiotherapy:Patients will be conducted CT simulation, and three-dimensional radiation therapy or Intensity-modulated radiation therapy was performed. 1.8Gy/fraction, 5 fractions a week, with a total dose of 4140cgy will be delivered for all patients by 6-MV-X-ray of linear accelerator.
Chemotherapy:Patients will be concurrently administered with irradiation every 4 weeks with PF regimen (cis-platinum of 25 mg/m2/d, d1-3; 5-fluorouracil of 500mg/m2/d, d1-4) for 2 cycles.
Surgery:Patients will receive operation 4-8 weeks after chemoradiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Experimental | Radiation: radiotherapy, Procedure: SurgeryPF regimen (cis-platinum of 25 mg/m2/d, d1-3; 5-fluorouracil of 500mg/m2/d, d1-4) every 4 weeks for 2 cycles concurrently with three-dimensional radiation therapy or intensity-modulated radiotherapy followed by surgery 4-8weeks after neoadjuvant therapy in a standard manner. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage IIB or III, which is potentially resectable.
- Patients must not have received any prior anticancer therapy.
- More than 6 months of expected survival.
- Age ranges from 18 to 70 years.
- Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney.
Key exclusion criteria (6 listed)
- Patients are diagnosed or suspected to be allergic to cisplatin or 5-Fu.
- Patients with concomitant hemorrhagic disease.
- Pregnant or breast feeding.
- Inability to use gastric conduit after esophagectomy because of a prior surgery.
- Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more.
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 |
|---|---|---|
| radiotherapyThe clinical target volume of radiotherapy only includes the visible tumor and lymph nodes and the investigators wouldn't do any prophylactic radiation treatment. | Radiation | experimental arm |
| SurgerySurgery would be done 4-8 weeks after neoadjuvant chemoradiotherapy. | Procedure or surgery | experimental arm |
Primary outcome
Percentage of patients completing adjuvant chemoradiotherapy and surgery
Time frame: 4-8weeks after surgery
2 secondary outcomes
Percentage of R0 resection
Time frame: 4-8weeks after surgery
Percentage of pathological complete response
Time frame: 4-8weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
- Background: PubMed 26254683Shapiro J, van Lanschot JJB, Hulshof MCCM, van Hagen P, van Berge Henegouwen MI, Wijnhoven BPL, van Laarhoven HWM, Nieuwenhuijzen GAP, Hospers GAP, Bonenkamp JJ, Cuesta MA, Blaisse RJB, Busch ORC, Ten Kate FJW, Creemers GM, Punt CJA, Plukker JTM, Verheul HMW, Bilgen EJS, van Dekken H, van der Sangen MJC, Rozema T, Biermann K, Beukema JC, Piet AHM, van Rij CM, Reinders JG, Tilanus HW, Steyerberg EW, van der Gaast A; CROSS study group. Neoadjuvant chemoradiotherapy plus surgery versus surgery alone for oesophageal or junctional cancer (CROSS): long-term results of a randomised controlled trial. Lancet Oncol. 2015 Sep;16(9):1090-1098. doi: 10.1016/S1470-2045(15)00040-6. Epub 2015 Aug 5.
- Background: PubMed 22646630van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. doi: 10.1056/NEJMoa1112088.
- Background: PubMed 26246479Huang TC, Hsu CH, Lin CC, Tu YK. Systematic review and network meta-analysis: neoadjuvant chemoradiotherapy for locoregional esophageal cancer. Jpn J Clin Oncol. 2015 Nov;45(11):1023-8. doi: 10.1093/jjco/hyv119. Epub 2015 Aug 5.
- Background: PubMed 27391867Martinek J, Akiyama JI, Vackova Z, Furnari M, Savarino E, Weijs TJ, Valitova E, van der Horst S, Ruurda JP, Goense L, Triadafilopoulos G. Current treatment options for esophageal diseases. Ann N Y Acad Sci. 2016 Oct;1381(1):139-151. doi: 10.1111/nyas.13146. Epub 2016 Jul 8.
- Background: PubMed 27165288Ikebe M, Morita M, Yamamoto M, Toh Y. Neoadjuvant therapy for advanced esophageal cancer: the impact on surgical management. Gen Thorac Cardiovasc Surg. 2016 Jul;64(7):386-94. doi: 10.1007/s11748-016-0655-y. Epub 2016 May 10.
- Background: PubMed 25614726Purwar P, Bambarkar S, Jiwnani S, Karimundackal G, Laskar SG, Pramesh CS. Multimodality management of esophageal cancer. Indian J Surg. 2014 Dec;76(6):494-503. doi: 10.1007/s12262-014-1163-x. Epub 2014 Sep 11.
- Background: PubMed 24493117Kumagai K, Rouvelas I, Tsai JA, Mariosa D, Klevebro F, Lindblad M, Ye W, Lundell L, Nilsson M. Meta-analysis of postoperative morbidity and perioperative mortality in patients receiving neoadjuvant chemotherapy or chemoradiotherapy for resectable oesophageal and gastro-oesophageal junctional cancers. Br J Surg. 2014 Mar;101(4):321-38. doi: 10.1002/bjs.9418. Epub 2014 Feb 3.
- 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.
Xiaolong Fu, Ph.D study director
Department of Radiation Oncology,Shanghai Chest 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 radiotherapy and Surgery in people with Esophageal Cancer and Chemoradiation, run by Shanghai Chest 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 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 19 Oct 2016. 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 Jun Liu, Doctor (+862122200000 ext. 3602, drjunliu@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients completing adjuvant chemoradiotherapy and surgery (time frame: 4-8weeks after surgery). 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 NCT02938195, which also lists 7 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 19 Oct 2016.