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Neoplasm, EsophagealPhase 2NCT03791905

PET Imaging-guided Chemoradiotherapy in Esophageal Squamous Cell Carcinoma

A Phase 2 study testing Paclitaxel, Cisplatin and Oxaliplatin in people with Neoplasm, Esophageal and Squamous Cell Carcinoma, run by Mian XI at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Since multiple studies have demonstrated that PET can identify responders and non-responders to induction chemotherapy, using FDG-PET imaging to guide treatment decisions has prompted interest in clinical practice. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Neoplasm, Esophageal, Squamous Cell Carcinoma
What is being tested?
Paclitaxel, Cisplatin and Oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
1 siteChina
Study dates
15 Jan 2019to Dec 2023
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed squamous cell carcinoma of the esophagus;
  • Absence of hematogenous metastasis disease, confirmed by endoscopic ultrasound (EUS) and PET-CT scan (according to UICC TNM version 8);
  • Not suitable for surgery (either for medical reasons or patient's choice);
  • Age at diagnosis 18 to 70 years;
  • Eastern Cooperative Oncology Group performance status ≤ 2
  • No prior cancer therapy;
Show all 11Show fewer
  • No history of concomitant or previous malignancy;
  • Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL;
  • Renal function: Cr ≤ 1.25×UNL;
  • Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL;
  • Documented informed consent to participate in the trial.

Who cannot join

  • Younger than 18 or older than 70 years of age;
  • ECOG performance status of 3 or above;
  • Other cancer history;
  • Previous radiotherapy history;
  • Subjects with distant metastases;
  • Pregnancy or breast feeding. Women of childbearing age must use effective contraception;
  • Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension);
  • Evidence of bleeding diathesis or serious infection.

Trial locations and contacts

1 site in 1 country.

Mian XI, MD contact

+86-20-87343385

ximian@sysucc.org.cn

Mengzhong Liu, MD contact

+86-20-87343385

liumzh@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guanzhou, Guangdong, 510060

    Mian Xi, MD, +86-20-87343385, ximian@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase II Randomized Trial of PET Imaging in Assessing Response to Induction Chemotherapy in Esophageal Squamous Cell Carcinoma Treated With Definitive Chemoradiotherapy

Since multiple studies have demonstrated that PET can identify responders and non-responders to induction chemotherapy, using FDG-PET imaging to guide treatment decisions has prompted interest in clinical practice. The aim of this study was to evaluate whether changing chemotherapy regimen during radiation based on PET response to induction chemotherapy can improve clinical complete response (cCR) in patients with unresectable esophageal squamous cell carcinoma (ESCC).

Read the detailed description

A total of 216 patients with baseline PET scan were randomized to one of 2 induction chemotherapy arms: paclitaxel/cisplatin (TP) on days 1, 22 or FOLFOX (oxaliplatin, leucovorin, 5-FU) on days 1, 15, 29. Repeat PET was performed on days 36-42 and changes in max standardized uptake value (SUVmax) from baseline were assessed. Using a predefined cut-off value of a 35% decrease in SUVmax, PET responders (≥35% decrease in SUVmax) continued on the same chemotherapy regimen during radiotherapy, whereas PET non-responders (<35% decrease in SUVmax) crossed over to an alternative chemotherapy regimen concomitantly with radiation. All patients received external-beam radiation using intensity-modulated radiotherapy. The prescribed dose is generally 50-60 Gy in 25-28 fractions, 5 days per week.

Keywords
Esophageal squamous cell carcinoma, PET, Definitive chemoradiotherapy, Induction chemotherapy
Medical subject headings
Esophageal Neoplasms, Carcinoma, Squamous Cell, Esophageal Squamous Cell Carcinoma

What participants receive

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

  • PaclitaxelDrug

    Also called Taxol

    chemotherapy drug

  • CisplatinDrug

    Also called DDP

    chemotherapy drug

  • OxaliplatinDrug

    Also called OXA

    chemotherapy drug

  • 5-FUDrug

    Also called Fluorouracil

    chemotherapy drug

  • LeucovorinDrug

    Also called CF

    chemotherapy drug

  • Intensity-modulated radiotherapyRadiation

    Also called IMRT

    radiotherapy technique

  • PETDevice

    Also called PET-CT

    Using PET to evaluate response to induction chemotherapy

Study groups in NCT03791905
Study groupRoleWhat they receive
TP ArmExperimentalPatients with baseline PET scan assigned to this Arm will receive two cycles of 3-weekly schedule of induction chemotherapy with paclitaxel/cisplatin (TP), consisting of paclitaxel 150 mg/m2 on day 1 and cisplatin 75 mg/m2 on day 1. Repeat PET was performed on days 36-42 and changes in SUVmax from baseline were assessed. PET responders (≥35% decrease in SUVmax) continued on the same chemotherapy regimen during radiotherapy, whereas PET non-responders (<35% decrease in SUVmax) crossed over to FOLFOX regimen concomitantly with radiation. All patients received external-beam radiation using intensity-modulated radiotherapy. The prescribed dose is generally 50-60 Gy in 25-28 fractions.
Receives: Drug: Paclitaxel; Drug: Cisplatin; Radiation: Intensity-modulated radiotherapy; Device: PET
FOLFOX ArmExperimentalPatients with baseline PET scan assigned to this Arm will receive three cycles of 2-weekly schedule of induction chemotherapy with FOLFOX (oxaliplatin, leucovorin, 5-FU), consisting of oxaliplatin 85 mg/m2 on day 1, leucovorin 400 mg/m2, and 5-FU 2 g/m2 on day 1. Repeat PET was performed on days 36-42 and changes in SUVmax from baseline were assessed. PET responders (≥35% decrease in SUVmax) continued on the same chemotherapy regimen during radiotherapy, whereas PET non-responders (<35% decrease in SUVmax) crossed over to TP regimen concomitantly with radiation. All patients received external-beam radiation using intensity-modulated radiotherapy. The prescribed dose is generally 50-60 Gy in 25-28 fractions.
Receives: Drug: Oxaliplatin; Drug: 5-FU; Drug: Leucovorin; Radiation: Intensity-modulated radiotherapy; Device: PET

What is being measured

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

  1. clinical complete response

    RECIST (Response Evaluation Criteria in Solid Tumors) criteria was used to determine the tumor response. Tumor response was evaluated 3 months after the completion of treatment based on CT or PET-CT scans, endoscopy with biopsies.

    Measured: 3 months after the treatment (plus or minus 7 days)

Secondary outcomes (3)

  1. Overall survival

    From the enrollment to the date of death from any cause or date of lost follow-up

    Measured: 3 years after randomization

  2. Progression-free survival

    From the date of randomization to the date of disease progression or last follow-up

    Measured: 3 years after randomization

  3. Chemoradiotherapy-related toxicity

    Treatment-related toxicity

    Measured: From the date of randomization to the 3 months after treatment

Timeline

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

  1. First posted3 Jan 2019
  2. Study start15 Jan 2019
  3. Primary completionJul 2021 (estimated)
  4. Study completionDec 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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized parallel study
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
216 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03791905
Sponsor's protocol ID
PETESCC
Status last verified
Mar 2021
First submitted
31 Dec 2018
Last updated
23 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ku GY, Kriplani A, Janjigian YY, Kelsen DP, Rusch VW, Bains M, Chou J, Capanu M, Wu AJ, Goodman KA, Ilson DH. Change in chemotherapy during concurrent radiation followed by surgery after a suboptimal positron emission tomography response to induction chemotherapy improves outcomes for locally advanced esophageal adenocarcinoma. Cancer. 2016 Jul 1;122(13):2083-90. doi: 10.1002/cncr.30028. Epub 2016 May 6.

    PubMed 27152857

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel, Cisplatin and Oxaliplatin in people with Neoplasm, Esophageal and Squamous Cell Carcinoma, run by Mian XI 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 11 inclusion and 8 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 23 Mar 2021. 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?

Results are not available in the source record.

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

Contact Mian XI, MD (+86-20-87343385, ximian@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

clinical complete response (time frame: 3 months after the treatment (plus or minus 7 days)). 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 NCT03791905, 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 23 Mar 2021.

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