Back to resultsPET Imaging-guided Chemoradiotherapy in Esophageal Squamous Cell Carcinoma
Primary Purpose
Neoplasm, Esophageal, Squamous Cell Carcinoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Paclitaxel
Cisplatin
Oxaliplatin
5-FU
Leucovorin
Intensity-modulated radiotherapy
PET
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasm, Esophageal focused on measuring Esophageal squamous cell carcinoma, PET, Definitive chemoradiotherapy, Induction chemotherapy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Sun Yat-sen University Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
TP Arm
FOLFOX Arm
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Overall survival
From the enrollment to the date of death from any cause or date of lost follow-up
Progression-free survival
From the date of randomization to the date of disease progression or last follow-up
Chemoradiotherapy-related toxicity
Treatment-related toxicity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03791905
Brief Title
PET Imaging-guided Chemoradiotherapy in Esophageal Squamous Cell Carcinoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mian XI
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm, Esophageal, Squamous Cell Carcinoma
Keywords
Esophageal squamous cell carcinoma, PET, Definitive chemoradiotherapy, Induction chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized parallel study
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
216 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TP Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
FOLFOX Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
chemotherapy drug
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
DDP
Intervention Description
chemotherapy drug
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
OXA
Intervention Description
chemotherapy drug
Intervention Type
Drug
Intervention Name(s)
5-FU
Other Intervention Name(s)
Fluorouracil
Intervention Description
chemotherapy drug
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Other Intervention Name(s)
CF
Intervention Description
chemotherapy drug
Intervention Type
Radiation
Intervention Name(s)
Intensity-modulated radiotherapy
Other Intervention Name(s)
IMRT
Intervention Description
radiotherapy technique
Intervention Type
Device
Intervention Name(s)
PET
Other Intervention Name(s)
PET-CT
Intervention Description
Using PET to evaluate response to induction chemotherapy
Primary Outcome Measure Information:
Title
clinical complete response
Description
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.
Time Frame
3 months after the treatment (plus or minus 7 days)
Secondary Outcome Measure Information:
Title
Overall survival
Description
From the enrollment to the date of death from any cause or date of lost follow-up
Time Frame
3 years after randomization
Title
Progression-free survival
Description
From the date of randomization to the date of disease progression or last follow-up
Time Frame
3 years after randomization
Title
Chemoradiotherapy-related toxicity
Description
Treatment-related toxicity
Time Frame
From the date of randomization to the 3 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mian XI, MD
Phone
+86-20-87343385
Email
ximian@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Mengzhong Liu, MD
Phone
+86-20-87343385
Email
liumzh@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mian XI, MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guanzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mian Xi, MD
Phone
+86-20-87343385
Email
ximian@sysucc.org.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27152857
Citation
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.
Results Reference
result
Learn more about this trial
PET Imaging-guided Chemoradiotherapy in Esophageal Squamous Cell Carcinoma
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