PET Imaging-guided Chemoradiotherapy in Esophageal Squamous Cell Carcinoma

March 21, 2021 updated by: Mian XI

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

216

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guanzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-Sen University Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TP Arm
Patients 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.
Drug: Paclitaxel
chemotherapy drug
Other Names:
  • Taxol
Drug: Cisplatin
chemotherapy drug
Other Names:
  • DDP
Radiation: Intensity-modulated radiotherapy
radiotherapy technique
Other Names:
  • IMRT
Device: PET
Using PET to evaluate response to induction chemotherapy
Other Names:
  • PET-CT
Experimental: FOLFOX Arm
Patients 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.
Radiation: Intensity-modulated radiotherapy
radiotherapy technique
Other Names:
  • IMRT
Device: PET
Using PET to evaluate response to induction chemotherapy
Other Names:
  • PET-CT
Drug: Oxaliplatin
chemotherapy drug
Other Names:
  • OXA
Drug: 5-FU
chemotherapy drug
Other Names:
  • Fluorouracil
Drug: Leucovorin
chemotherapy drug
Other Names:
  • CF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical complete response
Time Frame: 3 months after the treatment (plus or minus 7 days)
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.
3 months after the treatment (plus or minus 7 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 3 years after randomization
From the enrollment to the date of death from any cause or date of lost follow-up
3 years after randomization
Progression-free survival
Time Frame: 3 years after randomization
From the date of randomization to the date of disease progression or last follow-up
3 years after randomization
Chemoradiotherapy-related toxicity
Time Frame: From the date of randomization to the 3 months after treatment
Treatment-related toxicity
From the date of randomization to the 3 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mian XI

Investigators

  • Study Chair: Mian XI, MD, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2019

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

December 31, 2018

First Submitted That Met QC Criteria

December 31, 2018

First Posted (Actual)

January 3, 2019

Study Record Updates

Last Update Posted (Actual)

March 23, 2021

Last Update Submitted That Met QC Criteria

March 21, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PETESCC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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