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Esophageal CancerPhase 3NCT03731442

Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients

A Phase 3 study testing Involved field irradiation, Elective field irradiation and Paclitaxel in people with Esophageal Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Currently, adjuvant therapy is not recommended for patients with esophageal squamous cell carcinoma who received radical surgery. However, the recurrence rate is as high as 23.8%-58%, and the median time-to-recurrence is about 10.5 months. Read more about this study

Who is it for?
Ages 16 to 70 years
Conditions the study is for
Esophageal Cancer
What is being tested?
Involved field irradiation, Elective field irradiation and Paclitaxel
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteChina
Study dates
1 Nov 2018to 31 Oct 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 16 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Locoregional recurrence after radical surgery;
  • Positive resection margin (R1/R2) after surgery;
  • Out-of-field recurrence after adjuvant chemoradiation or radiotherapy;
  • Recurrence after adjuvant chemotherapy;
  • No prior therapy after recurrence;
  • Age 16-70 years;
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  • KPS>70;
  • No history of drug allergy;
  • Sufficient liver and kidney functions;
  • White blood cell count > 4.0*10^9/L.

Who cannot join

  • Age>70 or <16 years;
  • Pregnancy or lactation;
  • History of drug allergy;
  • Declining informed consent;
  • Insufficient liver or kidney functions, or abnormal CBC test;
  • Severe cardiovascular diseases, infections, active ulcerations, diabetes mellitus with unstable blood sugar, mental disorders.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zefen Xiao, MD contact

+86-13621018159

xiaozefen@sina.com

Lei Deng, MD contact

+86-18611766429

dengleipumc@163.com

China1 site, 1 recruiting

  • Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)

    Beijing, Beijing Municipality, 100021

    Zefen Xiao, MD

    Recruiting

Other trials in China

About this study

Official title: Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients: A Prospective, Multicenter Clinical Trial

Currently, adjuvant therapy is not recommended for patients with esophageal squamous cell carcinoma who received radical surgery. However, the recurrence rate is as high as 23.8%-58%, and the median time-to-recurrence is about 10.5 months. In patients who had residual tumor after surgery, evidence lacks for chemoradiation. The aim of the study is to evaluate the efficacy and safety of chemoradiation therapy in patients with recurrences after radical surgery or palliative surgery.

Read the detailed description

Currently, adjuvant therapy is not recommended for patients with esophageal squamous cell carcinoma who received surgery as their first treatment. However, the recurrence rate is as high as 23.8%-58%, and the median time-to-recurrence is about 10.5 months. In patients who had residual tumor after surgery, evidence lacks for chemoradiation.

Retrospective data of 218 cases in our hospital indicated patients underwent salvage chemoradiation had significantly improved survival compared with chemotherapy, radiotherapy or best supportive care. For patients with locoregional recurrence, the 1-, 3-year overall survival (OS) rates were statistically higher in patients received salvage chemoradiation than radiotherapy (1-year OS, 70.0% vs. 55.2%, 3-year OS, 41.9% vs. 23.5%, p=0.045). Patients received chemotherapy had 1-year OS of 0%.

Data of 218 cases of our hospital indicated patients received radiation dose > 54Gy had a significantly longer median overall survival time of 21.2 months compared with 11.3 months in patients had <54Gy. The optimal radiation dose should be further investigated.

The recurrence pattern of patients with esophageal cancer after esophagectomy mainly consist of supraclavicular and mediastinal lymph nodes. For patients recurred after radical surgery, prophylactic irradiation to high-risk lymph node regions should be considered. The study use simultaneously integrated boost (SIB) intensity-modulated radiation therapy (IMRT) in this trial, which made different radiation dose to recurrent tumor and high-risk lymph node regions possible.

The aim of the study is to evaluate the efficacy and safety of chemoradiation therapy in patients with recurrences after radical surgery or palliative surgery. Patients were further assigned to receive elective field irradiation (ENI) or involved field irradiation (IFI) according to tumor size, tumor location and time-to-recurrence.

Being tested
Involved field irradiation, Elective field irradiation, Paclitaxel, Platinum, PEG-rhG-CSF
Keywords
Salvage therapy, Recurrence, Chemoradiation
Medical subject headings
Esophageal Neoplasms, Recurrence

What participants receive

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

  • Involved field irradiationRadiation

    Involved field irradiation; intensity-modulated radiation therapy

  • Elective field irradiationRadiation

    Elective field irradiation; intensity-modulated radiation therapy

  • PaclitaxelDrug

    Paclitaxel 135-150mg/m2, d1, every 3 weeks

  • PlatinumDrug

    for lobaplatin, 30mg/m2, d1-2, total dose should not exceed 50mg,every 3 weeks; for nedaplatin 50mg/m2, d1-2, every 3 weeks;

  • PEG-rhG-CSFDrug

    PEG-rhG-CSF 3-6mg, 48 hours after chemotherapy

Study groups in NCT03731442
Study groupRoleWhat they receive
Involved field irradiationExperimentalPatients after R0 surgery whose recurrence lesion larger than 5cm in diameter, or largest diameter was less than 5cm but with skip metastasis far from primary tumor or their time-to-recurrence longer than 16 months were assigned to involved field irradiation group. For lesions far from the thoracic stomach, the prescribed dose is 60Gy/2Gy/30f, and for lesions close to the thoracic stomach, the prescribed dose is 59.4-61.2Gy/1.8Gy/33-34f. Chest CT scan is planned at 50Gy. Radiation field should be modified according to the tumor response. Concurrent chemotherapy of paclitaxel and platinum was delivered every 3 weeks. PEG-rhG-CSF (3-6mg) should be given after 48 hours of chemotherapy.If patients received postoperative chemotherapy of paclitaxel and platinum and went through local-regional recurrence within six months, it is allowed to deliver chemotherapy regimens in the second line. Consolidate chemotherapy were adjusted to the patients after radiation therapy.
Receives: Radiation: Involved field irradiation; Drug: Paclitaxel; Drug: Platinum; Drug: PEG-rhG-CSF
Elective field irradiationExperimentalPatients after R1/R2 surgery or R0 surgery with the recurrence lesion whose diameter was less than 5cm without skip metastasis far from primary tumor and time-to-recurrence shorter than 16 months were assigned to elective field irradiation group. For lesions far from the thoracic stomach, the prescribed dose is 50.4Gy/1.8Gy/28f with a simultaneously integrated boost up to 59.92-62.16Gy/2.14-2.22Gy/28f. For lesions close to the thoracic stomach, the prescribed dose is 50.4Gy/1.8Gy/28f with a sequential boost of 10-12Gy/1.8-2Gy/5-7f. For patients whose planned thoracic stomach V50>50%, the dose should be lowered to 45Gy/1.8Gy/25f. Concurrent chemotherapy of paclitaxel and platinum was delivered every 3 weeks. PEG-rhG-CSF should be given in need. If patients received postoperative chemotherapy of TP and went through local-regional recurrence within 6 months, chemotherapy regimens delivered in the second line. Consolidate chemotherapy were adjusted to the patients after radiation therapy.
Receives: Radiation: Elective field irradiation; Drug: Paclitaxel; Drug: Platinum; Drug: PEG-rhG-CSF

What is being measured

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

  1. 1-, 2-, 3-year overall survival

    Overall survival

    Measured: From treatment initiation to death from any cause or censor, assessed up to 36 months

Secondary outcomes (4)

  1. 1-, 2-, 3-year local progression-free survival

    Local progression-free survival

    Measured: From treatment initiation to first documented local progression or death or censor, assessed up to 36 months

  2. 1-, 2-, 3-year progression-free survival

    Progression-free survival

    Measured: From treatment initiation to first documented progression or death or censor, assessed up to 36 months

  3. Simultaneously integrated boost radiation therapy completion rate

    Radiation therapy completion rate

    Measured: During chemoradation, assessed up to 60 days

  4. Toxicities according to RTOG and CTCAE criteria, including hematological and non-hematological toxicities

    Toxicities of chemoradiation therapy

    Measured: Assessed within 3 months from initiation of chemoradiaiton (acute), and 3 months after initiation of chemoradiation (late), according to RTOG and CTCAE criteria, including hematological and non-hematological toxicities

Timeline

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

  1. First posted6 Nov 2018
  2. Study start1 Nov 2018
  3. Primary completion31 Oct 2022 (estimated)
  4. Study completion31 Oct 2027 (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
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03731442
Sponsor's protocol ID
18-175/1753
Status last verified
Dec 2018
First submitted
31 Oct 2018
Last updated
12 Dec 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chang X, Deng L, Ni W, Li C, Han W, Gao LR, Wang S, Zhou Z, Chen D, Feng Q, Liang J, Bi N, Lv J, Gao S, Mao Y, Xue Q, Xiao Z. Salvage chemoradiation therapy for recurrence after radical surgery or palliative surgery in esophageal cancer patients: a prospective, multicenter clinical trial protocol. BMC Cancer. 2020 Sep 14;20(1):877. doi: 10.1186/s12885-020-07315-0.

    PubMed 32928136

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Involved field irradiation, Elective field irradiation and Paclitaxel in people with Esophageal Cancer, run by Chinese Academy of Medical Sciences 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 10 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: looking for participants now, as of the sponsor's last update on 12 Dec 2018. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zefen Xiao, MD (+86-13621018159, xiaozefen@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-, 2-, 3-year overall survival (time frame: From treatment initiation to death from any cause or censor, assessed up to 36 months). 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 NCT03731442, which also lists 1 linked publication.

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 12 Dec 2018.

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