Induction Chemotherapy Followed by Chemoradiotherapy in Esophageal Cancer

Mian XI

Status and phase: Completed; Phase 2

Conditions: Neoplasms

Treatments: Drug: Docetaxel; Drug: Cisplatin; Radiation: Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02403531

ICCRTEC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Concurrent chemoradiotherapy

Active Comparator group

Description:

Patients assigned to this Arm received concurrent chemoradiotherapy. 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.

Treatment:

Radiation: Radiotherapy

Drug: Cisplatin

Drug: Docetaxel

Induction chemotherapy plus chemoradiotherapy

Experimental group

Description:

Patients assigned to this Arm first received two cycles of 3-weekly schedule of IC before definitive chemoradiotherapy, 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.

Treatment:

Radiation: Radiotherapy

Drug: Cisplatin

Drug: Docetaxel