Thoracic Esophageal Squamous Cell CarcinomaPhase 3NCT01137123

Improve the Treatment of Thoracic Esophageal Cancer

A Phase 3 study testing adjuvant chemotherapy, standard two field Lymphadenectomy and Total two field Lymphadenectomy in people with Thoracic Esophageal Squamous Cell Carcinoma, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is 1. To compare the effects of the two types of thoracic esophageal cancer lymphadenectomy on the staging and prognosis of resectable esophageal cancer, which defined by the International Association of esophageal disease(ISDE) - standard mediastinal lymphadenectomy,total mediastinal… Read more about this study

Who is it for?: Ages Up to 70 years
Conditions the study is for: Thoracic Esophageal Squamous Cell Carcinoma
What is being tested?: adjuvant chemotherapy, standard two field Lymphadenectomy and Total two field Lymphadenectomy
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 301 participants
Where: 1 siteChina
Study dates: Apr 2010to Dec 2020
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 Up to 70 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Age≤70 years old;
Karnofsky Performance Status（KPS）≥80;
Pathological diagnosis is squamous cell carcinoma of thoracic esophageal which is treated initially;
Clinical stage is c T 1 ~ 3 N 0 ~ 1 according to the results of endoscopic ultrasonography，chest and abdomen CT and neck ultrasonic.
The preoperative evaluation of organ function is tolerant of surgery and chemotherapy;
The subject can understand and sign the informed consent form (ICF);
The following laboratory tests, made in 4 weeks before first medication, confirmed that bone marrow, liver and kidney function in line with the requirements to participate in research; Hemoglobin（HGB）≥9.0g/L; absolute neutrophils count（ANC）≥1.5×109/L; platelet count（PLT）≥100×109/L; total bilirubin（TBIL）≤1.5N;aspartate aminotransferase (AST)≤2.5N;alanine aminotransferase(ALT)≤2.5N;prothrombin time(PT)≤1.5N, and activated partial thromboplastin time(APTT) is in normal range;endogenous creatinine clearance rate(CRE)≤1.5N.

Who cannot join

Cervical esophageal cancer and Non-squamous cell carcinoma of thoracic esophageal cancer;
Advanced Esophageal Cancer;
Prior malignancy in 5 years recently;
History of previous chest radiotherapy;
History of cardio-cerebral vascular accident in 6 months lately;
The subject can not understand and sign the informed consent form(ICF).

Trial locations and contacts

1 site in 1 country.

China1 site

Sun Yat-sen Uniersity Cancer Center
Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: A Prospective Clinical Trial of Improving the Treatment of Thoracic Esophageal Cancer

The purpose of this study is

To compare the effects of the two types of thoracic esophageal cancer lymphadenectomy on the staging and prognosis of resectable esophageal cancer, which defined by the International Association of esophageal disease(ISDE) - standard mediastinal lymphadenectomy,total mediastinal lymphadenectomy and three field lymphadenectomy,and to find out reasonable range of lymphadenectomy.
To compare the effects of Chemotherapy Group (Docetaxel + Nedaplatin) with Control Group on the prognosis of resectable thoracic esophageal cancer,and to explore the indications of adjuvant chemotherapy.

Read the detailed description

According to different location of the primary lesion，the subject can be allocated to two sub-groups:

The patient with upper or middle thoracic esophageal cancer may be assigned to two field(T)-total mediastinal lymphadenectomy group,which is control group in this study or three field lymphadenectomy-Abdominal + mediastinal + cervical lymphadenectomy group,which is study group in this study randomly.

After the operation,the patient whose primary lesion is completely(R0) resected will be assigned to adjuvant chemotherapy group or interview group randomly.

Conditions: Thoracic Esophageal Squamous Cell Carcinoma
Being tested: adjuvant chemotherapy, standard two field Lymphadenectomy, Total two field Lymphadenectomy, three field Lymphadenectomy
Keywords: esophageal squamous cell carcinoma
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.

adjuvant chemotherapyDrug
Docetaxel 75mg/m2 +Nedaplatin 75mg/m2,IV drip on day 1 of each 21 day cycle. Number of cycles: till unacceptable toxicity develops and no more than 4 cycles.
standard two field LymphadenectomyProcedure or surgery
Also called two field(S)
Standard two field lymphadenectomy is standard mediastinal lymphadenectomy which defined by the International Association of esophageal disease(ISDE) of thoracic esophageal cancer.
Total two field LymphadenectomyProcedure or surgery
Also called two field(T)
Total two field Lymphadenectomy is total mediastinal lymphadenectomy which defined by the International Association of esophageal disease(ISDE) of thoracic esophageal cancer.
three field LymphadenectomyProcedure or surgery
Also called three field
Three field Lymphadenectomy includes abdominal,mediastinal and cervical lymphadenectomy.

Study groups in NCT01137123
Study group	Role	What they receive
standard two field +follow-up	Active comparator	Not described Receives: Procedure: standard two field Lymphadenectomy
standard two field +adjuvant chemotherapy	Experimental	Not described Receives: Drug: adjuvant chemotherapy; Procedure: standard two field Lymphadenectomy
total two field+follow-up	Experimental	Not described Receives: Procedure: Total two field Lymphadenectomy
total two field+adjuvant chemotherapy	Experimental	Not described Receives: Drug: adjuvant chemotherapy; Procedure: Total two field Lymphadenectomy
three field+follow-up	Experimental	Not described Receives: Procedure: three field Lymphadenectomy
three field+adjuvant chemotherapy	Experimental	Not described Receives: Drug: adjuvant chemotherapy; Procedure: three field Lymphadenectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

survival rate
1. Disease-free survival
2. overall survival
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Dec 2020

First posted4 Jun 2010 (estimated)
Study startApr 2010
Primary completionDec 2020
Study completionDec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Thoracic Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
More trials run by Sun Yat-sen 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: Factorial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 301 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01137123
Sponsor's protocol ID: 2007044
Status last verified: Sep 2021
First submitted: 3 Jun 2010
Last updated: 31 Mar 2022
Results posted: No
Data monitoring committee: Yes

Publications

Parkin DM, Bray FI, Devesa SS. Cancer burden in the year 2000. The global picture. Eur J Cancer. 2001 Oct;37 Suppl 8:S4-66. doi: 10.1016/s0959-8049(01)00267-2. No abstract available.
PubMed 11602373
Urschel JD, Vasan H, Blewett CJ. A meta-analysis of randomized controlled trials that compared neoadjuvant chemotherapy and surgery to surgery alone for resectable esophageal cancer. Am J Surg. 2002 Mar;183(3):274-9. doi: 10.1016/s0002-9610(02)00795-x.
PubMed 11943125
Peracchia A, Bonavina L, Ruol A, Stein H. Esophageal cancer: a European perspective. Recent Results Cancer Res. 2000;155:119-22. doi: 10.1007/978-3-642-59600-1_12.
PubMed 10693245
Isono K, Sato H, Nakayama K. Results of a nationwide study on the three-field lymph node dissection of esophageal cancer. Oncology. 1991;48(5):411-20. doi: 10.1159/000226971.
PubMed 1745490
Kato H, Watanabe H, Tachimori Y, Iizuka T. Evaluation of neck lymph node dissection for thoracic esophageal carcinoma. Ann Thorac Surg. 1991 Jun;51(6):931-5. doi: 10.1016/0003-4975(91)91008-j.
PubMed 2039322
Nishihira T, Hirayama K, Mori S. A prospective randomized trial of extended cervical and superior mediastinal lymphadenectomy for carcinoma of the thoracic esophagus. Am J Surg. 1998 Jan;175(1):47-51. doi: 10.1016/s0002-9610(97)00227-4.
PubMed 9445239
Watanabe H. [Necessity of cervical lymph node dissection by retrospective analysis of submucosal cancer in mid-thoracic esophagus]. Nihon Geka Gakkai Zasshi. 1997 Sep;98(9):733-6. Japanese.
PubMed 9370130
Law SY, Fok M, Wong J. Pattern of recurrence after oesophageal resection for cancer: clinical implications. Br J Surg. 1996 Jan;83(1):107-11. doi: 10.1002/bjs.1800830134.
PubMed 8653330
Medical Research Council Oesophageal Cancer Working Group. Surgical resection with or without preoperative chemotherapy in oesophageal cancer: a randomised controlled trial. Lancet. 2002 May 18;359(9319):1727-33. doi: 10.1016/S0140-6736(02)08651-8.
PubMed 12049861
Kelsen DP, Ginsberg R, Pajak TF, Sheahan DG, Gunderson L, Mortimer J, Estes N, Haller DG, Ajani J, Kocha W, Minsky BD, Roth JA. Chemotherapy followed by surgery compared with surgery alone for localized esophageal cancer. N Engl J Med. 1998 Dec 31;339(27):1979-84. doi: 10.1056/NEJM199812313392704.
PubMed 9869669
Polee MB, Tilanus HW, Eskens FA, Hoekstra R, Van der Burg ME, Siersema PD, Stoter G, Van der Gaast A. Phase II study of neo-adjuvant chemotherapy with paclitaxel and cisplatin given every 2 weeks for patients with a resectable squamous cell carcinoma of the esophagus. Ann Oncol. 2003 Aug;14(8):1253-7. doi: 10.1093/annonc/mdg328.
PubMed 12881388
Keresztes RS, Port JL, Pasmantier MW, Korst RJ, Altorki NK. Preoperative chemotherapy for esophageal cancer with paclitaxel and carboplatin: results of a phase II trial. J Thorac Cardiovasc Surg. 2003 Nov;126(5):1603-8. doi: 10.1016/s0022-5223(03)00710-4.
PubMed 14666040
Desoize B, Madoulet C. Particular aspects of platinum compounds used at present in cancer treatment. Crit Rev Oncol Hematol. 2002 Jun;42(3):317-25. doi: 10.1016/s1040-8428(01)00219-0.
PubMed 12050023
Yamanaka H, Motohiro T, Michiura T, Asai A, Mori T, Hioki K. Nedaplatin and 5-FU combined with radiation in the treatment for esophageal cancer. Jpn J Thorac Cardiovasc Surg. 1998 Oct;46(10):943-8. doi: 10.1007/BF03217851.
PubMed 9847566
Yoshioka T, Gamoh M, Shineha R, Ishibashi S, Shibata H, Suzuki T, Murakawa Y, Kato S, Shimodaira H, Kato S, Ishioka C, Kanamaru R. A new combination chemotherapy with cis-diammine-glycolatoplatinum (Nedaplatin) and 5-fluorouracil for advanced esophageal cancers. Intern Med. 1999 Nov;38(11):844-8. doi: 10.2169/internalmedicine.38.844.
PubMed 10563743

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Thoracic Esophageal Squamous Cell Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Clinical Trial of Improving the Treatment of Thoracic Esophageal Cancer
ClinicalTrials.gov ID: NCT01137123
Acronym / sponsor ID: 2007044
Conditions: Thoracic Esophageal Squamous Cell Carcinoma
Keywords: esophageal squamous cell carcinoma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 301 participants (actual)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
Study start: Apr 2010
Primary completion: Dec 2020 (actual)
Study completion: Dec 2020 (actual)
First posted: 4 Jun 2010 (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 purpose of this study is

To compare the effects of the two types of thoracic esophageal cancer lymphadenectomy on the staging and prognosis of resectable esophageal cancer, which defined by the International Association of esophageal disease(ISDE) - standard mediastinal lymphadenectomy,total mediastinal lymphadenectomy and three field lymphadenectomy,and to find out reasonable range of lymphadenectomy.
To compare the effects of Chemotherapy Group (Docetaxel + Nedaplatin) with Control Group on the prognosis of resectable thoracic esophageal cancer,and to explore the indications of adjuvant chemotherapy.

Detailed description

According to different location of the primary lesion，the subject can be allocated to two sub-groups:

After the operation,the patient whose primary lesion is completely(R0) resected will be assigned to adjuvant chemotherapy group or interview group randomly.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (outcomes assessor)
Number of arms: 6

Arm	Type	Receives
standard two field +follow-up	Active comparator	Procedure: standard two field Lymphadenectomy
standard two field +adjuvant chemotherapy	Experimental	Drug: adjuvant chemotherapy, Procedure: standard two field Lymphadenectomy
total two field+follow-up	Experimental	Procedure: Total two field Lymphadenectomy
total two field+adjuvant chemotherapy	Experimental	Drug: adjuvant chemotherapy, Procedure: Total two field Lymphadenectomy
three field+follow-up	Experimental	Procedure: three field Lymphadenectomy
three field+adjuvant chemotherapy	Experimental	Drug: adjuvant chemotherapy, Procedure: three field Lymphadenectomy

Who may qualify

Ages: Up to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

Age≤70 years old;
Karnofsky Performance Status（KPS）≥80;
Pathological diagnosis is squamous cell carcinoma of thoracic esophageal which is treated initially;
Clinical stage is c T 1 ~ 3 N 0 ~ 1 according to the results of endoscopic ultrasonography，chest and abdomen CT and neck ultrasonic.
The preoperative evaluation of organ function is tolerant of surgery and chemotherapy;

Key exclusion criteria (6 listed)

Cervical esophageal cancer and Non-squamous cell carcinoma of thoracic esophageal cancer;
Advanced Esophageal Cancer;
Prior malignancy in 5 years recently;
History of previous chest radiotherapy;
History of cardio-cerebral vascular accident in 6 months lately;

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
adjuvant chemotherapyDocetaxel 75mg/m2 +Nedaplatin 75mg/m2,IV drip on day 1 of each 21 day cycle. Number of cycles: till unacceptable toxicity develops and no more than 4 cycles.	Drug	standard two field +adjuvant chemotherapy, three field+adjuvant chemotherapy, total two field+adjuvant chemotherapy
standard two field LymphadenectomyAlso: two field(S)Standard two field lymphadenectomy is standard mediastinal lymphadenectomy which defined by the International Association of esophageal disease(ISDE) of thoracic esophageal cancer.	Procedure or surgery	standard two field +adjuvant chemotherapy, standard two field +follow-up
Total two field LymphadenectomyAlso: two field(T)Total two field Lymphadenectomy is total mediastinal lymphadenectomy which defined by the International Association of esophageal disease(ISDE) of thoracic esophageal cancer.	Procedure or surgery	total two field+adjuvant chemotherapy, total two field+follow-up
three field LymphadenectomyAlso: three fieldThree field Lymphadenectomy includes abdominal,mediastinal and cervical lymphadenectomy.	Procedure or surgery	three field+adjuvant chemotherapy, three field+follow-up

Primary outcome

survival rate
Time frame: 5 years
1. Disease-free survival 2. overall survival

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
Background: PubMed 11602373Parkin DM, Bray FI, Devesa SS. Cancer burden in the year 2000. The global picture. Eur J Cancer. 2001 Oct;37 Suppl 8:S4-66. doi: 10.1016/s0959-8049(01)00267-2. No abstract available.
Background: PubMed 11943125Urschel JD, Vasan H, Blewett CJ. A meta-analysis of randomized controlled trials that compared neoadjuvant chemotherapy and surgery to surgery alone for resectable esophageal cancer. Am J Surg. 2002 Mar;183(3):274-9. doi: 10.1016/s0002-9610(02)00795-x.
Background: PubMed 10693245Peracchia A, Bonavina L, Ruol A, Stein H. Esophageal cancer: a European perspective. Recent Results Cancer Res. 2000;155:119-22. doi: 10.1007/978-3-642-59600-1_12.
Background: PubMed 1745490Isono K, Sato H, Nakayama K. Results of a nationwide study on the three-field lymph node dissection of esophageal cancer. Oncology. 1991;48(5):411-20. doi: 10.1159/000226971.
Background: PubMed 2039322Kato H, Watanabe H, Tachimori Y, Iizuka T. Evaluation of neck lymph node dissection for thoracic esophageal carcinoma. Ann Thorac Surg. 1991 Jun;51(6):931-5. doi: 10.1016/0003-4975(91)91008-j.
Background: PubMed 9445239Nishihira T, Hirayama K, Mori S. A prospective randomized trial of extended cervical and superior mediastinal lymphadenectomy for carcinoma of the thoracic esophagus. Am J Surg. 1998 Jan;175(1):47-51. doi: 10.1016/s0002-9610(97)00227-4.
Background: PubMed 9370130Watanabe H. [Necessity of cervical lymph node dissection by retrospective analysis of submucosal cancer in mid-thoracic esophagus]. Nihon Geka Gakkai Zasshi. 1997 Sep;98(9):733-6. Japanese.
Background: PubMed 8653330Law SY, Fok M, Wong J. Pattern of recurrence after oesophageal resection for cancer: clinical implications. Br J Surg. 1996 Jan;83(1):107-11. doi: 10.1002/bjs.1800830134.
Background: PubMed 12049861Medical Research Council Oesophageal Cancer Working Group. Surgical resection with or without preoperative chemotherapy in oesophageal cancer: a randomised controlled trial. Lancet. 2002 May 18;359(9319):1727-33. doi: 10.1016/S0140-6736(02)08651-8.
Background: PubMed 9869669Kelsen DP, Ginsberg R, Pajak TF, Sheahan DG, Gunderson L, Mortimer J, Estes N, Haller DG, Ajani J, Kocha W, Minsky BD, Roth JA. Chemotherapy followed by surgery compared with surgery alone for localized esophageal cancer. N Engl J Med. 1998 Dec 31;339(27):1979-84. doi: 10.1056/NEJM199812313392704.
Background: PubMed 12881388Polee MB, Tilanus HW, Eskens FA, Hoekstra R, Van der Burg ME, Siersema PD, Stoter G, Van der Gaast A. Phase II study of neo-adjuvant chemotherapy with paclitaxel and cisplatin given every 2 weeks for patients with a resectable squamous cell carcinoma of the esophagus. Ann Oncol. 2003 Aug;14(8):1253-7. doi: 10.1093/annonc/mdg328.
Background: PubMed 14666040Keresztes RS, Port JL, Pasmantier MW, Korst RJ, Altorki NK. Preoperative chemotherapy for esophageal cancer with paclitaxel and carboplatin: results of a phase II trial. J Thorac Cardiovasc Surg. 2003 Nov;126(5):1603-8. doi: 10.1016/s0022-5223(03)00710-4.
Related InfoLink provided by the sponsor.

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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.

Peng Lin, Professor principal investigator

651, Dongfeng Road East, Guangzhou, P. R. China

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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: finished, as of the sponsor's last update on 31 Mar 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

survival rate (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 NCT01137123, which also lists 15 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 31 Mar 2022.