AzTrials
AzTrials

Esophageal NeoplasmsPhase 3NCT02891083

Adjuvant Therapies or Surgery Alone for High Risk pN0 Esophageal Cancer

A Phase 3 study testing Adjuvant chemotherapy (Paclitaxel and Cisplatin) and Adjuvant radiotherapy in people with Esophageal Neoplasms, run by Shanghai Chest Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Histological Node Negative thoracic esophageal squamous cell carcinoma（pN0 ESCC） after radical resection still carries the risk of recurrence after complete surgical resection, especially in some high-risk patients. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Neoplasms
What is being tested?
Adjuvant chemotherapy (Paclitaxel and Cisplatin) and Adjuvant radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
486 participants
Where
1 siteChina
Study dates
Jan 2016to Jan 2021
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient: No pretreatment before surgery.Informed consent signed after screening;
  • Surgery: Complete (R0) resection of tumor, with thoraco- abdominal two-field or cervico-thoraco-abdominal three-field lymph node dissection through transthoracic esophagectomy. At least 12 stations and 12 lymph nodes should be harvested, including bilateral recurrent laryngeal nerve nodes. Both open thoracotomy and minimally invasive thoracoscopic/laparoscopic approaches are allowed and histopathological examination confirmed the diagnosis of the patients with at least cleaning more or equal to 12 stations and 12 lymph nodes;
  • Histology: Thoracic esophageal squamous cell carcinoma, with no nodal involvement (pN0) after pathological examination;
  • Staging: Tumor T stage T1b-T4a according to the 7th UICC esophageal cancer staging system;
  • Definition of high risk for recurrence: meet at least one of the three below.
  • A: Primary tumor located in middle or upper third of thoracic esophagus
Show all 13Show fewer
  • B: Presence of lymphovascular invasion (LVI) or submucosal metastasis
  • C: Cell differentiation:Low grade or undifferentiated
  • Performance status: ECOG score 0-2;
  • Cardiac function:NYHA classification 1-2. Normal electrocardiogram;
  • Renal function: Normal serum creatinine level (SCr = 120mol/L) and creatinine clearance rate (CCr = 60 ml/min);
  • Hepatic function: Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) level less than or equal to 2.0 times the upper limit of normal (ULN). Serum alkaline phosphatase (ALP) level less than or equal to four times the upper limit of normal value. Serum total bilirubin level less than or equal to 1.5 times the upper limit of the normal value;
  • Hematopoietic function: White blood cell count (WBC) equal to or more than 4000 / μL,neutrophils (ANC) absolute count is more than or equal to 1500 / μ L, platelet count more than or equal to 100000/ μ L, hemoglobin equal to or more than 10.0 g / dl.

Who cannot join

  • Surgery through Left thoracic or transhiatal approach, whereby complete lymphadenectomy is not achieved;
  • Patients experienced severe postoperative complication and thus, are unable to tolerate any adjuvant therapy;
  • Patients who have concommitant other malignant tumor;
  • Patients with abnormal coagulation function, with bleeding tendencies (such as active peptic ulcer) or are currently receiving thrombolysis or anticoagulation therapies;
  • Severe cardiac comorbidities, including congestive heart failure,uncontrolled cardiac arrhythmia, unstable angina pectoris, myocardial infarction within six months,severe heart valve disease, or intractable hypertension;
  • Severe hepatic or renal insufficiency;
  • Poor mental status or mental disorders, poor compliance.

Trial locations and contacts

1 site in 1 country.

Wentao Fang, MD contact

+86-21-62821990 ext. 2901

vwtfang12@shcheat.org

Xufeng Guo, MD contact

+86-21-62821990 ext. 2608

shandagxf@126.com

China1 site, 1 recruiting

  • Shanghai Chest Hospital

    Shanghai, 200030

    Wentao Fang, MD, +86-21-62821990 ext. 2901, vwtfang12@shchest.org

    Xufeng Guo, MD, +86-21-62821900 ext. 2608, shandagxf@126.com

    Recruiting

Other trials in China

About this study

Official title: Multi-center Prospective Randomized Controlled Clinical Trial of Postoperative Adjuvant Chemotherapy, Adjuvant Radiotherapy, or Surgery Alone for High-risk Histological Node Negative Patients With Thoracic Esophageal Squamous Cell Carcinoma

Histological Node Negative thoracic esophageal squamous cell carcinoma（pN0 ESCC） after radical resection still carries the risk of recurrence after complete surgical resection, especially in some high-risk patients. There are still lack of knowledge on postoperative treatment indication and methods for pN0 ESCC.Our previous study has shown that risk of recurrence is associated with the location and cell differentiation of primary tumor, as well as the presence of lymphovascular invasion. This project is designed to study the efficacy of adjuvant therapies for at patients with pN0 ESCC and above mentioned risk factors of recurrence after radical surgery. We aim to compare the differences among adjuvant chemotherapy, adjuvant radiotherapy, and surgery alone for pN0 ESCC by prospective randomized controlled trial. There has been no similar studies in esophageal cancer previously reported with similar design. The results of this study is expected to have a high clinical relevance.

Read the detailed description

The study is designed to be a prospective randomized controlled trial, aiming to compare the impact of adjuvant chemotherapy with Paclitaxel and Cisplatin, adjuvant radiotherapy with IMRT of 50Gy, and surgery alone on the disease free survival (DFS) of patients with high-risk pN0 thoracic esophageal squamous cell carcinoma. Pathological staging is to be based on the 7th UICC edition, after radical resection and systemic lymph node dissection,for accurate staging.Patients with pT1b-T4a disease, proved to be pN0 upon pathological examination, meet at least one of the risk factors in the inclusion criteria, and without any exclusion criteria are to be randomized into one of the three study arms.Definition of high-risk factors for recurrence include: (1)Tumor location: in the middle or upper third thoracic esophagus; (2) Presence of LVI or submucosal metastasis; (3) Cell differentiation: poorly differentiated or undifferentiated.

Primary endpoint:

To observe and compare Disease-Free Survivals (DFS) among the three study arms.

Secondary endpoint:

To observe and compare Overall Survivals (OS) among the three study arms, and to compare adverse events between adjuvant chemotherapy and adjuvant radiation groups.

Additional instructions:

No.

Being tested
Adjuvant chemotherapy (Paclitaxel and Cisplatin), Adjuvant radiotherapy, Control group (Surgery alone)
Keywords
adjuvant chemotherapy, adjuvant radiotherapy, lymph node metastasis, surgery, squamous cell carcinoma
Medical subject headings
Esophageal Neoplasms, Lymphatic Metastasis, Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adjuvant chemotherapy (Paclitaxel and Cisplatin)Drug

    Also called Paclitaxel and Cisplatin

    Adjuvant chemotherapy group: three cycles: (Paclitaxel: 175mg/m2 ivgtt, 3h, d1 4week × 3 and cisplatin: 75mg/m2 ivgtt, d1 4 week × 3)

  • Adjuvant radiotherapyRadiation

    Also called cobalt-60

    Target: the upper mediastinum and bilateral supraclavicular region (Upper bound: thyrocricoid, lower bound: carina of 3cm)

    Dose: 50Gy

    Technology: strong tone

    Segmentation: conventional segmentation 2Gy/d

  • Control group (Surgery alone)Other

    Also called Surgery alone

Study groups in NCT02891083
Study groupRoleWhat they receive
Adjuvant chemotherapy groupExperimentalSurgery followed by adjuvant chemotherapy,with Paclitaxel and Cisplatin.
Receives: Drug: Adjuvant chemotherapy (Paclitaxel and Cisplatin)
Adjuvant radiotherapy groupExperimentalSurgery followed by 50Gy adjuvant radiotherapy
Receives: Radiation: Adjuvant radiotherapy
Control groupOtherSurgery alone
Receives: Other: Control group (Surgery alone)

What is being measured

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

  1. Disease free survival

    Measured: 3 years

Secondary outcomes (2)

  1. Overall survival

    Measured: 5 years

  2. side effect of adjuvant therapy

    Measured: 6 months

Timeline

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

  1. First posted7 Sep 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionJan 2019 (estimated)
  4. Study completionJan 2021 (estimated)

Resources

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
486 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02891083
Sponsor's protocol ID
2016shchest
Status last verified
Sep 2016
First submitted
1 Sep 2016
Last updated
7 Sep 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Guo XF, Mao T, Gu ZT, Ji CY, Fang WT, Chen WH. Clinical study on postoperative recurrence in patients with pN0 esophageal squamous cell carcinoma. J Cardiothorac Surg. 2014 Aug 28;9:150. doi: 10.1186/s13019-014-0150-4.

    PubMed 25164541

  • Shim YM, Kim HK, Kim K. Comparison of survival and recurrence pattern between two-field and three-field lymph node dissections for upper thoracic esophageal squamous cell carcinoma. J Thorac Oncol. 2010 May;5(5):707-12. doi: 10.1097/JTO.0b013e3181d3ccb2.

    PubMed 20421764

  • Ando N, Iizuka T, Ide H, Ishida K, Shinoda M, Nishimaki T, Takiyama W, Watanabe H, Isono K, Aoyama N, Makuuchi H, Tanaka O, Yamana H, Ikeuchi S, Kabuto T, Nagai K, Shimada Y, Kinjo Y, Fukuda H; Japan Clinical Oncology Group. Surgery plus chemotherapy compared with surgery alone for localized squamous cell carcinoma of the thoracic esophagus: a Japan Clinical Oncology Group Study--JCOG9204. J Clin Oncol. 2003 Dec 15;21(24):4592-6. doi: 10.1200/JCO.2003.12.095.

    PubMed 14673047

  • Tachimori Y, Nagai Y, Kanamori N, Hokamura N, Igaki H. Pattern of lymph node metastases of esophageal squamous cell carcinoma based on the anatomical lymphatic drainage system. Dis Esophagus. 2011 Jan;24(1):33-8. doi: 10.1111/j.1442-2050.2010.01086.x.

    PubMed 20626450

  • Wu SG, Dai MM, He ZY, Sun JY, Lin HX, Lin H, Li Q. Patterns of Regional Lymph Node Recurrence After Radical Surgery for Thoracic Esophageal Squamous Cell Carcinoma. Ann Thorac Surg. 2016 Feb;101(2):551-7. doi: 10.1016/j.athoracsur.2015.08.057. Epub 2015 Oct 31.

    PubMed 26530541

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adjuvant chemotherapy (Paclitaxel and Cisplatin) and Adjuvant radiotherapy in people with Esophageal Neoplasms, 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 13 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 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 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 Wentao Fang, MD (+86-21-62821990 ext. 2901, vwtfang12@shcheat.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease free survival (time frame: 3 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 NCT02891083, which also lists 5 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 7 Sep 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in