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Oligorecurrent and Oligometastatic Esophageal Squamous Cell CarcinomaPhase 2NCT03904927

Local Therapy for Oligorecurrent and Oligometastatic Esophageal Squamous Cell Carcinoma

A Phase 2 study testing Radiation, Surgery or Radiofrequency ablation and Systemic therapy in people with Oligorecurrent and Oligometastatic Esophageal Squamous Cell Carcinoma, run by Fudan 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
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Trial summary

The aim of the study is to determine if intervening with combined local therapy and chemotherapy prior to chemotherapy alone in patients with oligorecurrent and oligometastatic esophageal squamous cell carcinoma led to significant improvements in progression-free survival (PFS). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Radiation, Surgery or Radiofrequency ablation and Systemic therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
1 siteChina
Study dates
1 Feb 2019to 15 Sep 2024
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with oligometastatic diseases and pathologically confirmed esophageal squamous cell carcinoma after initial radical treatment [i.e., completely resected surgery or radical (chemo)radiotherapy], the primary esophageal sites are controlled.
  • Note:
  • Definition of metastasis: patients with distant organ metastases or non-regional lymph node metastases; or patients with distant organs/non-regional lymph node metastases and regional lymph node metastases as defined in the eighth edition of the AJCC. Patients with only regional lymph node metastasis and/or anastomotic/esophageal recurrence are not eligible for enrollment.
  • According to the classification of oligometastatic disease, oligometastasis including synchronous oligometastasis, metachronous oligometastasis, and repeat oligometastasis could be enrolled in this trial.
  • In visceral metastases or non-regional lymph node metastases, at least one metastatic lesion obtains pathological confirmation.
  • The total number of metastases is 4 or less and maximum 3 metastases in any single organ system (i.e. lung, liver). The maximum diameter for each lesion should be no more than 5 cm.
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  • Each lesion was counted separately at the time of registration and contributed to the total number of metastases.If regional recurrences are existed, all positive regional lymph nodes are count together as one lesion. For non-regional lymph node metastases, adjacent metastatic lymph nodes can be treated as one lesion.
  • Lesions that have subsided during previous treatment (i.e., were no longer visible on CT or had eliminated affinity on PET-CT) are not included in the total number. For patients with synchronous oligometastasis, the controlled primary tumor and regional lymph nodes on imaging are counted toward the total of 4.
  • All metastases of current diagnosis did not receive local treatment such as radiotherapy, surgery, radiofrequency ablation before enrollment.
  • Previous chemotherapy was allowed, but no anti-tumor medication was received within 3 months prior to the start of treatment.
  • The measurable lesion was determined by the investigator based on the RECIST 1.1 assessment. A lesion located in a previous radiotherapy area can be considered a target lesion if it is confirmed to progress and is considered to be measurable according to RECIST 1.1.
  • The patient is over 18 years old and has an ECOG score of 0-1.
  • Estimated survival time >12 weeks.
  • The function of vital organs meets the following requirements:
  • Neutrophil absolute count (ANC) ≥ 1.5 × 10^9 / L
  • platelets ≥ 100 × 10^9 / L;
  • Hemoglobin ≥ 9g / dL;
  • serum albumin ≥ 2.8g / dL;
  • Total bilirubin ≤ 1.5 × ULN, ALT, AST and / or AKP ≤ 2.5 × ULN; if there is liver metastasis, ALT and / or AST ≤ 5 × ULN; if there is liver metastasis or bone metastasis AKP ≤ 5 × ULN;
  • serum creatinine ≤ 1.5 × ULN or creatinine clearance > 60 mL / min;
  • For patients with pulmonary lesions or previous lung irradiation who are known or suspected to have impaired lung function, the forced expiratory volume (FEV1) for 1 second of lung function must be above 1L.
  • Female subjects of childbearing age must have a negative urine or serum pregnancy test within 72 hours prior to randomization. Subjects agreed to adequate contraception during the trial.
  • The patient is voluntarily enrolled and obtained the informed consent form signed by the patient or his legal representative.

Who cannot join

  • Primary tumor of esophagus is confirmed uncontrolled or progressive by imaging or gastroscope,or any esophageal or nodal recurrence locates in the previous radiation field.
  • The pathological diagnosis of any metastatic lesion is clearly different from the primary tumor or diagnosed as a second primary tumor.
  • Patients participated in any investigational drug study within 4 weeks preceding the start of treatment.
  • If there is a metastasis within 3 months after definitive treatment, or the number of metastases is more than 4.
  • Patients with uncontrolled brain metastases, or vertebral body metastasis with spinal cord compression symptoms.
  • The toxicity of previous anti-tumor treatment has not recovered to ≤ National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 level 1 (except for hair loss) or the level specified by the inclusion/exclusion criteria.
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  • Patients with uncontrolled pleural, pericardial or pelvic effusion that requires repeated drainage.
  • Patients who have received chemotherapy, anti-tumor medication, major surgery or severe trauma within 3 months before enrollment.
  • Pregnant or breastfeeding women.
  • Patients with history of immunodeficiency, or severe medical diseases that are not well controlled, which may have effect on the treatment of this study.
  • Any other malignant tumor was diagnosed within 5 years prior to or after the diagnosis of ESCC, except for malignant tumors with a low risk of metastasis and death (5-year survival rate >90%), such as well-treated basal cells or squamous cell skin cancer or cervical cancer in situ.
  • The investigator judged that patients could not cooperate with the treatment, or have other factors that might cause him to be forced to terminate the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan Universtiy Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: Role of Local Therapy for Patients with Oligorecurrent and Oligometastatic Esophageal Squamous Cell Carcinoma After Radical Treatment: a Prospective, Randomized Phase II Clinical Study

The aim of the study is to determine if intervening with combined local therapy and chemotherapy prior to chemotherapy alone in patients with oligorecurrent and oligometastatic esophageal squamous cell carcinoma led to significant improvements in progression-free survival (PFS).

Being tested
Radiation, Surgery or Radiofrequency ablation, Systemic therapy

What participants receive

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

  • Radiation, Surgery or Radiofrequency ablationOther

    Patients with no more than 4 metastases located in less than 3 organs/ lymphatic drainage regions treated with combined systemic therapy and radiation, surgery or radiofrequency.

  • Systemic therapyDrug

    1. First-line chemotherapy (previously without chemotherapy), paclitaxel 175mg/m2, d1+cisplatin 25mg/m2, d1-3, repeated every 28 days, intravenous infusion, a total of 4 cycles.
    2. If patients have a history of chemotherapy, use a regimen of docetaxel 75mg/m2, d1, intravenous infusion, repeated every 21 days for a total of 4 cycles. If previously use docetaxel but not irinotecan, then use a regimen of irinotecan 180mg/m2, d1, d15, repeated every 28 days for a total of 4 cycles. If both docetaxel and irinotecan have been used, the investigator could decide the chemotherapy regimen.
    3. Anti-PD1 antibodies plus chemotherapy could be used as first-line systemic therapy and Anti-PD1 antibodies could be used as second-line therapy.
Study groups in NCT03904927
Study groupRoleWhat they receive
Experimental ArmExperimentalThe arm will be treated with combined systemic therapy and local therapy such as radiation, surgery or radiofrequency ablation.
Receives: Other: Radiation, Surgery or Radiofrequency ablation; Drug: Systemic therapy
Control ArmActive comparatorThe arm will be treated with systemic therapy alone.
Receives: Drug: Systemic therapy

What is being measured

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

  1. Progression-free survival

    progression-free survival will be measured as time to either progression or death

    Measured: Time from the date of randomisation to the date of progression or date of death from any cause, whichever came first, assessed up to 3 years

Secondary outcomes (2)

  1. Overall survival

    Overall survival will be measured as time to death from any cause.

    Measured: The survival time from the date of randomisation to the date of death from any cause, assessed up to 3 years

  2. Local control

    Local control will be measured as time to local recurrence

    Measured: the time from the date of randomisation to the date of local failure or the last follow-up, assessed up to 3 years

Timeline

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

  1. First posted5 Apr 2019
  2. Study start1 Feb 2019
  3. Primary completion1 Jan 2022
  4. Study completion15 Sep 2024

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03904927
Sponsor's protocol ID
ESO-Shanghai13
Status last verified
Oct 2024
First submitted
28 Mar 2019
Last updated
23 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liu Q, Chen J, Lin Y, Ye J, Shen W, Luo H, Li B, Huang W, Wei S, Song J, Wang Y, Yang H, Lai S, Zhu H, Ai D, Chen Y, Deng J, Hao S, Zhao K. Systemic therapy with or without local intervention for oligometastatic oesophageal squamous cell carcinoma (ESO-Shanghai 13): an open-label, randomised, phase 2 trial. Lancet Gastroenterol Hepatol. 2024 Jan;9(1):45-55. doi: 10.1016/S2468-1253(23)00316-3. Epub 2023 Nov 18.

    PubMed 37980921

  • Liu Q, Chen J, Li B, Ye J, Wei S, Wang Y, Yang H, Zhu Z, Lai S, Li L, Chen Y, Wang J, Xiang J, Zhao K. Local therapy for oligometastatic esophageal squamous cell carcinoma: a prospective, randomized, Phase II clinical trial. Future Oncol. 2021 Apr;17(11):1285-1293. doi: 10.2217/fon-2020-0873. Epub 2021 Feb 25.

    PubMed 33626929

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiation, Surgery or Radiofrequency ablation and Systemic therapy in people with Oligorecurrent and Oligometastatic Esophageal Squamous Cell Carcinoma, run by Fudan University 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 23 inclusion and 12 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 23 Oct 2024. 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?

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?

Progression-free survival (time frame: Time from the date of randomisation to the date of progression or date of death from any cause, whichever came first, assessed up to 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 NCT03904927, which also lists 2 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 23 Oct 2024.

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