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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03791905
Other study ID # PETESCC
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date January 15, 2019
Est. completion date December 2023

Study information

Verified date March 2021
Source Sun Yat-sen University
Contact Mian XI, MD
Phone +86-20-87343385
Email ximian@sysucc.org.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 216
Est. completion date December 2023
Est. primary completion date July 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Paclitaxel
chemotherapy drug
Cisplatin
chemotherapy drug
Oxaliplatin
chemotherapy drug
5-FU
chemotherapy drug
Leucovorin
chemotherapy drug
Radiation:
Intensity-modulated radiotherapy
radiotherapy technique
Device:
PET
Using PET to evaluate response to induction chemotherapy

Locations

Country Name City State
China Sun Yat-sen University Cancer Center Guanzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Mian XI

Country where clinical trial is conducted

China, 

References & 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 chem — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Overall survival From the enrollment to the date of death from any cause or date of lost follow-up 3 years after randomization
Secondary Progression-free survival From the date of randomization to the date of disease progression or last follow-up 3 years after randomization
Secondary Chemoradiotherapy-related toxicity Treatment-related toxicity From the date of randomization to the 3 months after treatment
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