PET Imaging-guided Chemoradiotherapy in Esophageal Squamous Cell Carcinoma

Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03791905
• Other study ID #: PETESCC
• Status: Recruiting
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma
• Neoplasm, Esophageal
• Squamous Cell Carcinoma

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