Induction Chemotherapy Followed by Chemoradiotherapy in Esophageal Cancer

Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02403531
• Other study ID #: ICCRTEC
• Status: Completed
• Phase: Phase 2
• Start date: May 1, 2015
• Est. completion date: May 30, 2020

Study information

• Verified date: May 2020
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 30, 2020
• Est. primary completion date: September 6, 2017
• 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. 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.

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Neoplasms

Intervention

Drug:
• Docetaxel
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• Cisplatin
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Radiation:
• Radiotherapy
definitive radiotherapy

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Mian XI

Country where clinical trial is conducted

China, 

References & Publications (4)

Ajani JA, Xiao L, Roth JA, Hofstetter WL, Walsh G, Komaki R, Liao Z, Rice DC, Vaporciyan AA, Maru DM, Lee JH, Bhutani MS, Eid A, Yao JC, Phan AP, Halpin A, Suzuki A, Taketa T, Thall PF, Swisher SG. A phase II randomized trial of induction chemotherapy versus no induction chemotherapy followed by preoperative chemoradiation in patients with esophageal cancer. Ann Oncol. 2013 Nov;24(11):2844-9. doi: 10.1093/annonc/mdt339. Epub 2013 Aug 23. — View Citation

Ilson DH, Minsky BD, Ku GY, Rusch V, Rizk N, Shah M, Kelsen DP, Capanu M, Tang L, Campbell J, Bains M. Phase 2 trial of induction and concurrent chemoradiotherapy with weekly irinotecan and cisplatin followed by surgery for esophageal cancer. Cancer. 2012 Jun 1;118(11):2820-7. doi: 10.1002/cncr.26591. Epub 2011 Oct 11. — View Citation

Koo DH, Park SI, Kim YH, Kim JH, Jung HY, Lee GH, Choi KD, Song HJ, Song HY, Shin JH, Cho KJ, Yoon DH, Kim SB. Phase II study of use of a single cycle of induction chemotherapy and concurrent chemoradiotherapy containing capecitabine/cisplatin followed by surgery for patients with resectable esophageal squamous cell carcinoma: long-term follow-up data. Cancer Chemother Pharmacol. 2012 Mar;69(3):655-63. doi: 10.1007/s00280-011-1750-5. Epub 2011 Oct 4. — View Citation

Ruhstaller T, Widmer L, Schuller JC, Roth A, Hess V, Mingrone W, von Moos R, Borner M, Pestalozzi BC, Balmermajno S, Köberle D, Terraciano L, Schnider A, Bodis S, Popescu R; Swiss Group for Clinical Cancer Research (SAKK). Multicenter phase II trial of preoperative induction chemotherapy followed by chemoradiation with docetaxel and cisplatin for locally advanced esophageal carcinoma (SAKK 75/02). Ann Oncol. 2009 Sep;20(9):1522-8. doi: 10.1093/annonc/mdp045. Epub 2009 May 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall response rate (clinical complete response and partial 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 barium esophagography, CT scans, and endoscopy with biopsies.	3 months after chemoradiotherapy (plus or minus 7 days)
Secondary	Overall survival	Three years follow-up from the enrollment to the date of death from any cause or date of lost follow-up	3 years
Secondary	Progression-free survival	From the date of randomization to the date of disease progression or last follow-up	3 years