PET Imaging-guided Chemoradiotherapy in Esophageal Squamous Cell Carcinoma

Phase 2UnknownNCT03791905

Mian XI216 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

216

Conditions

Neoplasm, Esophageal Squamous Cell Carcinoma

Interventions

PaclitaxelDRUG

chemotherapy drug

CisplatinDRUG

chemotherapy drug

OxaliplatinDRUG

chemotherapy drug

5-FU

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sun Yat-sen University Cancer Center

Guanzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 3 months after the treatment (plus or minus 7 days)

Secondary Outcomes

Overall survival

From the enrollment to the date of death from any cause or date of lost follow-up

Time frame: 3 years after randomization

Progression-free survival

From the date of randomization to the date of disease progression or last follow-up

Time frame: 3 years after randomization

Chemoradiotherapy-related toxicity

Treatment-related toxicity

Time frame: From the date of randomization to the 3 months after treatment

Central Contacts

Mian XI, MD

CONTACT

+86-20-87343385 ximian@sysucc.org.cn

Mengzhong Liu, MD

CONTACT

+86-20-87343385 liumzh@sysucc.org.cn

Data from ClinicalTrials.gov

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