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Status unknownNCT02891083Updated Sep 7, 2016

Adjuvant Therapies or Surgery Alone for High Risk pN0 Esophageal Cancer

A Phase 3 interventional study of Adjuvant chemotherapy (Paclitaxel and Cisplatin) and Adjuvant radiotherapy in Esophageal Neoplasms, sponsored by Shanghai Chest Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-09-07.

Sponsored by Shanghai Chest Hospital · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
486
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Esophageal Neoplasms

Keywords

  • adjuvant chemotherapy
  • adjuvant radiotherapy
  • lymph node metastasis
  • surgery
  • squamous cell carcinoma
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In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

This study's planned enrollment of 486 is above the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Shanghai Chest Hospital is the lead sponsor of 194 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patient: No pretreatment before surgery.Informed consent signed after screening;
  2. 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;
  3. Histology: Thoracic esophageal squamous cell carcinoma, with no nodal involvement (pN0) after pathological examination;
  4. Staging: Tumor T stage T1b-T4a according to the 7th UICC esophageal cancer staging system;

  5. 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

    B: Presence of lymphovascular invasion (LVI) or submucosal metastasis

    C: Cell differentiation:Low grade or undifferentiated

  6. Performance status: ECOG score 0-2;
  7. Cardiac function:NYHA classification 1-2. Normal electrocardiogram;
  8. Renal function: Normal serum creatinine level (SCr = 120mol/L) and creatinine clearance rate (CCr = 60 ml/min);
  9. 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;
  10. 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.

Exclusion criteria

Exclusion Criteria:

  1. Surgery through Left thoracic or transhiatal approach, whereby complete lymphadenectomy is not achieved;
  2. Patients experienced severe postoperative complication and thus, are unable to tolerate any adjuvant therapy;
  3. Patients who have concommitant other malignant tumor;
  4. Patients with abnormal coagulation function, with bleeding tendencies (such as active peptic ulcer) or are currently receiving thrombolysis or anticoagulation therapies;
  5. 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;
  6. Severe hepatic or renal insufficiency;
  7. Poor mental status or mental disorders, poor compliance.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
486 participants (estimated)

Study arms

  • Experimental
    Adjuvant chemotherapy group

    Surgery followed by adjuvant chemotherapy,with Paclitaxel and Cisplatin.

    Drug: Adjuvant chemotherapy (Paclitaxel and Cisplatin)

  • Experimental
    Adjuvant radiotherapy group

    Surgery followed by 50Gy adjuvant radiotherapy

    Radiation: Adjuvant radiotherapy

  • Other
    Control group

    Surgery alone

    Other: Control group (Surgery alone)

Interventions

  • DrugAdjuvant chemotherapy (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)

    Also known as: Paclitaxel and Cisplatin

  • RadiationAdjuvant radiotherapy

    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

    Also known as: cobalt-60

  • OtherControl group (Surgery alone)

    Also known as: Surgery alone

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What researchers measure

Primary outcomes

  1. Disease free survival

    Time frame: 3 years

Secondary outcomes

  1. Overall survival

    Time frame: 5 years

  2. side effect of adjuvant therapy

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Shanghai Chest Hospital
    Shanghai, 200030, China
    Recruiting
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References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02891083
Lead sponsor
Shanghai Chest Hospital
Collaborators
Tianjin Medical University Cancer Institute and Hospital, Sun Yat-sen University, Sichuan Cancer Hospital and Research Institute, Hunan Cancer Hospital, Fujian Cancer Hospital, Fudan University, Qingdao University, Fujian Medical University, Wuhan TongJi Hospital
Responsible party
Wentao Fang (Chief Director,Clinical Center of Esophageal Diseases,Shanghai Jiao tong University, Shanghai Chest Hospital) — Principal investigator
First posted
Sep 7, 2016
Start date
Jan 2016
Primary completion
Jan 2019 (estimated)
Completion
Jan 2021 (estimated)
Last update
Sep 7, 2016

Study contacts

Wentao Fang, MD
Contact
vwtfang12@shcheat.org
+86-21-62821990 ext. 2901
Xufeng Guo, MD
Contact
shandagxf@126.com
+86-21-62821990 ext. 2608
Wentao Fang, MD
principal investigator · Shanghai Chest Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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