PET Imaging-guided Chemoradiotherapy in Esophageal Squamous Cell Carcinoma
A Phase II Randomized Trial of PET Imaging in Assessing Response to Induction Chemotherapy in Esophageal Squamous Cell Carcinoma Treated With Definitive Chemoradiotherapy
1 other identifier
interventional
216
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2019
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 31, 2018
CompletedFirst Posted
Study publicly available on registry
January 3, 2019
CompletedStudy Start
First participant enrolled
January 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedMarch 23, 2021
March 1, 2021
2.5 years
December 31, 2018
March 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
3 months after the treatment (plus or minus 7 days)
Secondary Outcomes (3)
Overall survival
3 years after randomization
Progression-free survival
3 years after randomization
Chemoradiotherapy-related toxicity
From the date of randomization to the 3 months after treatment
Study Arms (2)
TP Arm
EXPERIMENTALPatients 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.
FOLFOX Arm
EXPERIMENTALPatients 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.
Interventions
Using PET to evaluate response to induction chemotherapy
Eligibility Criteria
You may qualify if:
- 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;
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mian XIlead
Study Sites (1)
Sun Yat-sen University Cancer Center
Guanzhou, Guangdong, 510060, China
Related Publications (1)
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.
PMID: 27152857RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mian XI, MD
Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Preofessor
Study Record Dates
First Submitted
December 31, 2018
First Posted
January 3, 2019
Study Start
January 15, 2019
Primary Completion
July 1, 2021
Study Completion
December 1, 2023
Last Updated
March 23, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share