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Status unknownNCT03273647Updated Oct 19, 2017

Adjuvant Radiotherapy for Esophageal Squamous Cell Carcinoma With Positive Circumstantial Resection Margin

A Phase 3 interventional study of radiation in Esophageal Squamous Cell Carcinoma and Positive Circumferential Resection Margin, sponsored by Fudan University. Status unknown. Open to participants aged 18 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-19.

Sponsored by Fudan University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 18 Years
Sex
All
01

Study summary

The purpose of this study is to determine the efficacy of adjuvant radiotherapy for esophageal squamous cell carcinoma with positive circumstantial resection margin.

Read the detailed description

Although preoperative chemoradiation therapy followed by surgery is the most common approach for patients with resectable esophageal cancer, the considerable number of esophageal cancer patients received operation as the first treatment modality. Accordingly, postoperative treatments have been playing an important role because of the poor survival rates of the patients who have been treated with resection alone. The existing data shows that the 5-yeal survival rate of stage T2-3N0M0(UICC 7th edition) of thoracic esophageal squamous cell carcinoma(TESCC) after surgery is about 50% ,and locoregional lymph nodes metastases is responsible for the main cause of failure while distal metastases account for relatively less ratio. Therefore, the subclinical residual tumor is affirmative even if the early disease has been undergone curable excision and local adjuvant treatment may be essential. In rectal cancer, the involvement of the circumferential resection margin (CRM) is one of the key factors for local recurrence and poor prognosis,based on reports in which CRM with \< 1mm was found to be prognostically significant, whereas the clinical and prognostic significance of the CRM involvement in EC has been investigated only in a few series showing conflicting results, as some studies suggest a significant influence of CRM. There is lack of clear evidence for prophylactic radiation therapy in positive Circumferential Resection Margin(CRM) patients of TESCC now. In view of this, the randomized controlled trial will determine the clinical efficacy and toxicity of adjuvant radiotherapy in positive Circumferential Resection Margin(CRM) for thoracic esophageal squamous cell carcinoma.

02

Conditions studied

  • Esophageal Squamous Cell Carcinoma
  • Positive Circumferential Resection Margin
03

In context

Esophageal Squamous Cell Carcinoma

657 studies on the registry are indexed under Esophageal Squamous Cell Carcinoma; 276 are open to participants now.

This study's planned enrollment of 60 is close to the median of 64 across 550 interventional studies indexed under Esophageal Squamous Cell Carcinoma.

Browse Esophageal Squamous Cell Carcinoma studies →

Lead sponsor

Fudan University is the lead sponsor of 1,308 studies on the registry; 637 are open to participants now.

Browse Fudan University studies →

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

04

Who can participate

Ages eligible
18 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients with esophageal cancer who received R0 operations in Fudan University Shanghai Cancer Center and postoperative pathology: squamous cell cancer,positive Circumferential Resection Margin(CRM)+

  • KPS≥70 before radiotherapy;
  • Did not receive neoadjuvant or adjuvant treatment;
  • No clear recurrent or metastatic lesions before radiotherapy;
  • Intensity modulated radiation therapy(IMRT) is accepted;
  • Regular follow-up.

Exclusion criteria

Exclusion Criteria:

  • Exploratory thoracotomy or palliative surgery;
  • No clear recurrent or metastatic sites;
  • Recurrence or metastasis is not certain;
  • death of no definite cause.
  • Irregular follow-up;
05

Study design

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

Study arms

  • Experimental
    surgery plus radiation

    adjuvant radiotherapy is developed in this arm

    Radiation: radiation

  • No intervention
    surgery alone

    No adjuvant radiotherapy,that is surgery alone is developed in this arm

Interventions

  • Radiationradiation

    A total dose of 40Gy will be delivered in 20 fractions at 2.0Gy/fraction, 5 fractions per week in 4 weeks. The CTV encompassed the bilateral supraclavicular region, all mediastinal lymph nodes, the anastomosis site, and the left gastric and Celiac nodes.

06

What researchers measure

Primary outcomes

  1. Disease-free survival time

    including survival time from randomization to locoregional recurrence and to distal metastasis

    Time frame: up to 3 years

Secondary outcomes

  1. overall survival time

    survival time from randomization to death

    Time frame: up to 3 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2017; primary completion for Dec 2019, 24 months later.

Of 42 phase 3 interventional studies under Esophageal Squamous Cell Carcinoma, half reached primary completion within 66 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 76. This study's planned 24 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 4, 2017
First posted
Sep 6, 2017
StartEst.
Dec 1, 2017
Primary completionEst.
Dec 1, 2019
CompletionEst.
Dec 1, 2024
Last update
Oct 19, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03273647
Lead sponsor
Fudan University
Responsible party
Jiaqing Xiang (Professor of Department of Thoracic Surgery, Fudan University Shanghai Cancer Center, Fudan University) — Principal investigator
First posted
Sep 6, 2017
Start date
Dec 1, 2017 (estimated)
Primary completion
Dec 1, 2019 (estimated)
Completion
Dec 1, 2024 (estimated)
Last update
Oct 19, 2017

Study contacts

Jiaqing Xiang, MD
Contact
j.q.xiang@hotmail.com
+86 13901992249
Yiliang Zhang, MD
Contact
ilya616@126.com
+86 18017317284
Jiaqing Xiang, MD
principal investigator · professor of Department of Thoracic Surgery, Fudan University Shanghai Cancer Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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