Clinical trial · Interventional

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

NCT03791905CI-TRIAL-00050832unknownPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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).

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Neoplasm, Esophageal	Esophageal Neoplasm	ONTOLOGY_EXACT	0.98
Squamous Cell Carcinoma	Squamous Cell Carcinoma	ONTOLOGY_EXACT	0.98

Interventions

Interventions (7)

Intervention	Type	Mapped drug	Match
5-FU	Drug	Fluorouracil	ALIAS
Cisplatin	Drug	Cisplatin	ALIAS
Intensity-modulated radiotherapy	Radiation	—	UNRESOLVED
Leucovorin	Drug	Leucovorin	ALIAS
Oxaliplatin	Drug	Oxaliplatin	ALIAS
Paclitaxel	Drug	Paclitaxel	ALIAS
PET	Device	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
TP 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.
interventionNames
1. Drug: Paclitaxel
2. Drug: Cisplatin
3. Radiation: Intensity-modulated radiotherapy
4. Device: PET
type
EXPERIMENTAL
label
FOLFOX 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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 70 Years

Show eligibility criteria text

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.

References

Publications (1)

RESULTKu 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 27152857

Registry

Dates and enrollment

Start: Jan 15, 2019
Primary completion: Jul 1, 2021
Completion: Dec 1, 2023
First posted: Jan 3, 2019
Last update posted: Mar 23, 2021
Enrollment: 216 (estimated)
Lead sponsor: Mian XI OTHER
Keywords: Esophageal squamous cell carcinoma, PET, Definitive chemoradiotherapy, Induction chemotherapy

Data updated 22 days agoSource updated Mar 23, 2021source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
China	1	1

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.