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Esophageal Squamous Cell CarcinomaPhase 2/3NCT03623737

Comparing Paclitaxel/Cisplatin and Cisplatin/5-fluorouracil in Neo-CRT for ESCC

A Phase 2/3 study testing neoadjuvant chemoradiation in people with Esophageal Squamous Cell Carcinoma and Chemoradiation, run by National Taiwan University Hospital at 1 site in Taiwan.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This clinical trial has two stages: phase II and phase III. Eligible patients will be randomized 1:1 to the two arms: paclitaxel plus cisplatin and cisplatin plus 5-fluorouracil. The phase II stage will enroll 128 patients, 64 patients for each arm. Read more about this study

Who is it for?
Ages 20 to 75 years
What is being tested?
neoadjuvant chemoradiation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
248 participants
Where
1 siteTaiwan
Study dates
1 Mar 2017to 1 Dec 2023
Phase
Phase 2/3
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 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically proven squamous cell carcinoma of the intrathoracic esophagus.
  • Locally advanced disease, which is defined by the TNM system of the American Joint Committee on Cancer (AJCC) Cancer Staging System (7th edition), fulfilling one of the following criteria as determined by endoscopic ultrasound, computed tomography, bronchoscopy and positron emission tomography:
  • T3/4a, N0, M0; B. T1-3, N1-3, M0;
  • Tumor length longitudinal ≤ 8cm and radial ≤ 5cm.
  • The tumor must not extend more than 2cm into the stomach.
  • The tumor must not involve cervical esophagus.
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  • No invasion of the tracheobronchial tree or presence of tracheoesophageal fistula.
  • Age ≥ 20 and ≤ 75 years old.
  • Performance status ECOG 0~2.
  • Adequate bone marrow reserves, defined as:
  • white blood cells (WBC) ≥ 4,000/µl or neutrophil count (ANC) ≥ 2,000/µl; B. platelets ≥ 100,000/µl.
  • Adequate liver function reserves, defined as:
  • hepatic transaminases ≤ 2.5 x upper limit of normal (ULN); B. serum total bilirubin ≤ 2.0 x upper limit of normal (ULN).
  • Adequate renal function: Creatinine ≤1.5 x upper normal limit or estimated creatinine clearance ≥ 50 ml/min (estimated by Cockcroft-Gault formulation)
  • Written informed consent.
  • Patients must be able to fill in quality of life questionnaires.

Who cannot join

  • Adenocarcinoma.
  • Previous thoracic irradiation.
  • Previous systemic chemotherapy
  • Synchronously diagnosed squamous cell carcinoma of aerodigestive way, other than esophageal cancer.
  • Prior malignancy, except for the following:
  • adequately treated basal cell or squamous cell skin cancer; B. in-situ cervical cancer; C. a "cured" malignancy more than 5 years prior to enrollment.
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  • Significant co-morbid disease, which prohibits the conduction of chemotherapy, concurrent chemo- radiotherapy, or radical surgery, such as active systemic infection, symptomatic cardiac or pulmonary disease, or psychiatric disorders.
  • Documented myocardial infarction within the 6 months preceding registration (pretreatment ECG evidence of infarct only will not exclude patients). Patients with a history of significant ventricular arrhythmia requiring medication. Patients with a history of 2nd or 3rd degree heart block.
  • Pre-existing motor or sensory neurotoxicity greater than grade 1.
  • Patients with prior allergic reactions to drug containing Cremophor, such as teniposide or cyclosporine.
  • Weight loss > 15%.
  • Dementia or altered mental status that would prohibit the understanding and completion of informed consent and questionnaires.
  • Estimated life expectancy less than 3 months.

Trial locations and contacts

1 site in 1 country.

Ta-Chen Huang, MD contact

+886937817390

e360215@gmail.com

Taiwan1 site, 1 recruiting

  • National Taiwan University Hospital

    Taipei

    Ta-Chen Huang, MD, +886-2-2312-3456, e360215@gmail.com

    Recruiting

Other trials in Taiwan

About this study

Official title: A Randomized Phase II/III Study of Paclitaxel/Cisplatin Versus Cisplatin/5-fluorouracil in Neoadjuvant Chemoradiation Followed by Surgery for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC)

This clinical trial has two stages: phase II and phase III. Eligible patients will be randomized 1:1 to the two arms: paclitaxel plus cisplatin and cisplatin plus 5-fluorouracil. The phase II stage will enroll 128 patients, 64 patients for each arm. The endpoint of the phase II stage is complete pathological response (pCR). If the endpoint, i.e., the significant improvement of pCR rate, is met, the clinical trial will proceed to the phase III stage, in which 120 more patients will be enrolled. The estimated enrollment time is four years with 3 more years of follow-up after completing enrollment. The primary endpoint of the clinical trial is overall survival, and the secondary endpoints include clinical response, disease free survival, operation rate, complete resection rate, tumor regression rate, hospital stay days after surgery, safety and toxicity, and quality of life.

Read the detailed description

Stage 1: Neoadjuvant chemoradiation (CRT):

Stage 2: Evaluation of clinical responses

  1. Evaluation will be done at 3±1 weeks after completing the last fraction of radiotherapy.
  2. Evaluation will be performed with panendoscopy, endoscopic ultrasonography (EUS), computed tomography (CT), and positron emission tomography (PET).

Stage 3: Surgery

  1. Patients will receive esophagectomy with two field lymph node dissection unless:
  2. Patients become medically unfit for surgery. B. Tumor becomes metastatic or unresectable. C. Patients refuse surgery.
  3. Patients who do not receive surgery will go on a second section of CRT:
  4. Radiation: 180cGy/fraction, once daily, 5 days a week, up to a total of 6,300cGy.
  5. Arm A:
  6. T: Paclitaxel 50 mg/m2, 1h IVF, weekly, week 1 to week 3 during CRT. ii. P: Cisplatin 30 mg/m2, 2 h IVF, weekly following paclitaxel, week 1 to week 3 during CRT.
  7. Arm B:
  8. P: Cisplatin 75 mg/m2, 2 h IVF, on day 1 of week 1 during CRT. ii. F: 5-FU 1,000 mg/m2, 24 h IVF, on day 1, 2, 3, 4 of week 1 during CRT.
  9. Patients, who receive surgery with R2 resection or the pathology showing positive margins or extracapsular invasion of regional lymph nodes, will also receive the second section of CRT described in above-mentioned stage 3-2.
Being tested
neoadjuvant chemoradiation
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

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

  • neoadjuvant chemoradiationDrug

    Also called esophagectomy

    Neoadjuvant chemoradiation:

    1. Radiation: 180cGy/fraction, once daily, 5 days a week, to a total of 4,500cGy.
    2. Chemotherapy: Arm A or Arm B Surgery: esophagectomy and 3-fields lymph node dissection
Study groups in NCT03623737
Study groupRoleWhat they receive
paclitaxel plus cisplatinExperimentalA. T: Paclitaxel 50 mg/m2, 1h IVF, weekly, week 1 to week 5 during CRT. B. P: Cisplatin 30 mg/m2, 2 h IVF, weekly following paclitaxel, week 1 to week 5 during CRT.
Receives: Drug: neoadjuvant chemoradiation
cisplatin plus 5-fluorouracilActive comparatorA. P: Cisplatin 75 mg/m2, 2 h IVF, on day 1 of week 1 and week 5 during CRT. B. F: 5-FU 1,000 mg/m2, 24 h IVF, on day 1, 2, 3, 4 of week 1 and week 5 during CRT.
Receives: Drug: neoadjuvant chemoradiation

What is being measured

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

  1. pathological complete response

    No cancer cells in primary tumor and all lymph nodes resected are observed by pathologists

    Measured: 2 years

Secondary outcomes (8)

  1. Overall survival

    Time from enrollment to death

    Measured: 4 years

  2. disease free survival

    From the day of surgery with R0 resection to recurrence or death of any reasons

    Measured: 4 years

  3. clinical response

    The clinical response evaluation for the effect of neoadjuvant CRT will be done around 3±1 weeks after completing CRT.

    Evaluation will be performed with panendoscopy, EUS, CT, and PET.

    Clinical responses assessment will include:

    1. Overall clinical response according to RECIST1.1 and Japanese Esophageal Society (JES)
    2. Endoscopic response criteria according to JES
    3. Metabolic response evaluated by PET

    Measured: 2 years

  4. operation rate

    The ratio of the number of patients who receive surgery over the number of patients enrolled

    Measured: 2 years

  5. R0 resection rate

    The ratio of the number of patients with surgical R0 resection over the number of patients who receive surgery

    Measured: 2 years

  6. tumor regression grade

    A 4-tiered tumor regression grading (TRG) system will be used according to the extent of residual carcinoma in the whole tumor area of the esophageal specimen.

    TRG 1: no residual carcinoma. TRG 2: 1%- 10% residual carcinoma. TRG 3: 11%- 50% residual carcinoma. TRG 4: >50% residual carcinoma

    Measured: 2 years

  7. The total score of participants of both arms will be analyzed and compared.

    By World Health Organization Quality of Life Brief Version (WHOQOL-BREF) Taiwan version (2005), quality of life will be assessed at enrollment, at the end of neoadjuvant CRT, and 3 months after surgery.

    There are 28 subscales in the questionnaire. Each subscale has 5 scores from 1 (the worst) to 5 (the best). The scores of each subscale are summed to be a total score.

    Measured: 2 years

  8. Number of participants with treatment-related adverse events as assessed by the NCI Common Toxicity Criteria (CTC)

    By the NCI Common Toxicity Criteria (CTC), version 4.0., number of participants with treatment-related adverse events, all grades and grade 3/4, will be assessed.

    Measured: 2 years

Timeline

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

  1. First posted9 Aug 2018
  2. Study start1 Mar 2017
  3. Primary completion1 Mar 2023 (estimated)
  4. Study completion1 Dec 2023 (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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
248 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03623737
Sponsor's protocol ID
201606102MIPB
Status last verified
Jun 2022
First submitted
27 Jun 2017
Last updated
7 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing neoadjuvant chemoradiation in people with Esophageal Squamous Cell Carcinoma and Chemoradiation, run by National Taiwan University Hospital at 1 site in Taiwan.

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 16 inclusion and 13 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 Jun 2022. 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 Taiwan. 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 combined 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.

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 Ta-Chen Huang, MD (+886937817390, e360215@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pathological complete response (time frame: 2 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 NCT03623737.

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 Jun 2022.

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