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PET Imaging-guided Chemoradiotherapy in Esophageal Squamous Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT03791905
Recruitment Status : Recruiting
First Posted : January 3, 2019
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
Mian XI, Sun Yat-sen University

Brief 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. 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).

Condition or disease Intervention/treatment Phase
Neoplasm, Esophageal Squamous Cell Carcinoma Drug: Paclitaxel Drug: Cisplatin Drug: Oxaliplatin Drug: 5-FU Drug: Leucovorin Radiation: Intensity-modulated radiotherapy Device: PET Phase 2

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  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized parallel study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


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 Name: Taxol

Drug: Cisplatin
chemotherapy drug
Other Name: DDP

Radiation: Intensity-modulated radiotherapy
radiotherapy technique
Other Name: IMRT

Device: PET
Using PET to evaluate response to induction chemotherapy
Other Name: 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.
Drug: Oxaliplatin
chemotherapy drug
Other Name: OXA

Drug: 5-FU
chemotherapy drug
Other Name: Fluorouracil

Drug: Leucovorin
chemotherapy drug
Other Name: CF

Radiation: Intensity-modulated radiotherapy
radiotherapy technique
Other Name: IMRT

Device: PET
Using PET to evaluate response to induction chemotherapy
Other Name: PET-CT




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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. Chemoradiotherapy-related toxicity [ Time Frame: From the date of randomization to the 3 months after treatment ]
    Treatment-related toxicity



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03791905


Contacts
Contact: Mian XI, MD +86-20-87343385 ximian@sysucc.org.cn
Contact: Mengzhong Liu, MD +86-20-87343385 liumzh@sysucc.org.cn

Locations
China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guanzhou, Guangdong, China, 510060
Contact: Mian Xi, MD    +86-20-87343385    ximian@sysucc.org.cn   
Sponsors and Collaborators
Mian XI
Investigators
Study Chair: Mian XI, MD Sun Yat-sen University

Publications of Results:
Responsible Party: Mian XI, Associate Preofessor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03791905     History of Changes
Other Study ID Numbers: PETESCC
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mian XI, Sun Yat-sen University:
Esophageal squamous cell carcinoma
PET
Definitive chemoradiotherapy
Induction chemotherapy

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Carcinoma
Carcinoma, Squamous Cell
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Paclitaxel
Oxaliplatin
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators