Clinical trial NCT02403531: Induction Chemotherapy Followed by Chemoradiotherapy in Esophageal Cancer
Official title: A Phase II Randomized Trial of Induction Chemotherapy Versus no Induction Chemotherapy Followed by Definitive Chemoradiotherapy in Patients With Inoperable Thoracic Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neoplasms
Keywords: Esophageal cancer
Chemoradiotherapy
induction chemotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-03-31
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The contribution of induction chemotherapy before definitive chemoradiotherapy is unknown. The purpose of this study was to compare the efficacy and toxicity of induction chemotherapy followed by definitive chemoradiotherapy versus no induction chemotherapy in patients with inoperable thoracic esophageal squamous cell carcinoma.

Detailed description: 108 patients were randomized to receive no induction chemotherapy (IC, Arm A) or IC (Arm B) before definitive chemoradiotherapy in patients with inoperable thoracic esophageal squamous cell carcinoma. Patients assigned to Arm B first received two cycles of 3-weekly schedule of IC, consisting of docetaxel 75 mg/m2 on day 1 and cisplatin 75 mg/m2 on day 1. The prescribed dose of radiotherapy is generally 50-60 Gy/25-28fr. The concomitant chemotherapy is docetaxel 20 mg/m2 on day 1, cisplatin 25 mg/m2 on day 1, repeated weekly during radiation.

Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed squamous cell carcinoma of the esophagus;
2. Localized, nonmetastatic disease (T1-4, N0-1) confirmed by endoscopic ultrasound (EUS) and CT scan (according to UICC TNM version 6);
3. Absence of distant metastasis of solid organ;
4. Not suitable for surgery (either for medical reasons or patient's choice);
5. Age at diagnosis 18 to 70 years;
6. Eastern Cooperative Oncology Group performance status ≤ 2
7. No prior cancer therapy;
8. No history of concomitant or previous malignancy;
9. Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL;
10. Renal function: Cr ≤ 1.25×UNL;
11. Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL;
12. 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.

Primary outcomes:
measure: overall response rate (clinical complete response and partial response)
timeFrame: 3 months after chemoradiotherapy (plus or minus 7 days)
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years
measure: Progression-free survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Meng-Zhong Liu, MD
role: STUDY_CHAIR
References:
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citation: Liu S, Luo L, Zhao L, Zhu Y, Liu H, Li Q, Cai L, Hu Y, Qiu B, Zhang L, Shen J, Yang Y, Liu M, Xi M. Induction chemotherapy followed by definitive chemoradiotherapy versus chemoradiotherapy alone in esophageal squamous cell carcinoma: a randomized phase II trial. Nat Commun. 2021 Jun 29;12(1):4014. doi: 10.1038/s41467-021-24288-1.