Concurrent Radiotherapy and Weekly Chemotherapy of PF for Postoperative Locoregional Recurrence of Esophageal Cancer

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

Concurrent Radiotherapy and Weekly Chemotherapy of 5-fluorouracil and Cisplatin for Postoperative Locoregional Recurrence of Oesophageal Squamous Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02325986
• Other study ID #: GD-B2014157
• Status: Recruiting
• Phase: Phase 2
• First received: December 16, 2014
• Last updated: November 19, 2015
• Start date: March 2015
• Est. completion date: December 2017

Study information

• Verified date: November 2015
• Source: Sun Yat-sen University
• Contact: Yujia Zhu, MD
• Phone: 86-20-87343385
• Email: zhuyuj[@]sysucc.org.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and toxicity of radiotherapy concurrently with weekly chemotherapy of 5-FU and cisplatin in patients with postoperative locoregional recurrence of esophageal squamous cell carcinoma.

Description:

The most optimal management for postoperative locoregional recurrence of oesophageal squamous cell carcinoma is still controversial. Several studies have reported the feasibility and efficacy of concurrent chemoradiotherapy (CCRT), mostly with three-weekly or four-weekly schedule of chemotherapy. However, treatment compliance was not quite satisfactory, probably due to treatment-related toxicities. Since CCRT with weekly chemotherapy regimens have demonstrated a favorable toxicity profile as well as promising survival in certain types of cancer, the investigators aimed to evaluate the efficacy and toxicity of radiotherapy concurrently with weekly chemotherapy with 5-fluorouracil (5-FU) and cisplatin for patients with postoperative locoregional recurrence of oesophageal squamous cell carcinoma in the investigators center.The prescribed dose of radiotherapy is generally 60Gy/28fr to tumor and 50Gy/28fr to the clinical target volume.The concomitant chemotherapy is cisplatin 25mg/m2 on day 1, 5-FU 1176mg/m2 on day 1-3, repeated weekly for 4 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. R0 resection for primary esophageal squamous cell carcinoma with two-incision esophagectomy (Ivor Lewis approach)25 or three-incision (right thoracotomy, midline laparotomy and left cervical incisions) esophagectomy with cervical esophagogastric anastomosis.

2. Absence of previous thoracic radiotherapy.

3. Cervical and/or thoracic postoperative recurrence (biopsy proven or positron emission tomography/computed tomography (PET/CT) proven or follow-up computed tomography (CT) showed progression of disease).

4. Absence of distant metastasis at recurrence.

5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 2

Exclusion Criteria:

1. Younger than 18 or older than 70 years of age.

2. Eastern Cooperative Oncology Group (ECOG) performance status of 3 or above

3. Other cancer history.

4. Serious cardiac, liver, or pulmonary disease.

5. Previous radiotherapy history

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• fluorouracil
cisplatin 25mg/m2 on day 1, fluorouracil 1176mg/m2 on day 1-3,repeated weekly for 4 weeks concurrently with IMRT radiotherapy (60Gy/28fr)
• Cisplatin
cisplatin 25mg/m2 on day 1, fluorouracil 1176mg/m2 on day 1-3,repeated weekly for 4 weeks concurrently with IMRT radiotherapy (60Gy/28fr)

Radiation:
• Intensity-modulated radiation therapy
cisplatin 25mg/m2 on day 1, fluorouracil 1176mg/m2 on day 1-3,repeated weekly for 4 weeks concurrently with IMRT radiotherapy (60Gy/28fr)

Locations

Country	Name	City	State
China	SYSU Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (11)

Bao Y, Liu S, Zhou Q, Cai P, Anfossi S, Li Q, Hu Y, Liu M, Fu J, Rong T, Li Q, Liu H. Three-dimensional conformal radiotherapy with concurrent chemotherapy for postoperative recurrence of esophageal squamous cell carcinoma: clinical efficacy and failure p — View Citation

Jingu K, Nemoto K, Matsushita H, Takahashi C, Ogawa Y, Sugawara T, Nakata E, Takai Y, Yamada S. Results of radiation therapy combined with nedaplatin (cis-diammine-glycoplatinum) and 5-fluorouracil for postoperative locoregional recurrent esophageal cance — View Citation

Kato H, Miyazaki T, Nakajima M, Sohda M, Fukai Y, Masuda N, Fukuchi M, Manda R, Tsukada K, Kuwano H. Prediction of hematogenous recurrence in patients with esophageal carcinoma. Jpn J Thorac Cardiovasc Surg. 2003 Nov;51(11):599-608. — View Citation

Kobayashi R, Yamashita H, Okuma K, Shiraishi K, Ohtomo K, Nakagawa K. Salvage radiation therapy and chemoradiation therapy for postoperative locoregional recurrence of esophageal cancer. Dis Esophagus. 2014 Jan;27(1):72-8. doi: 10.1111/dote.12068. Epub 2013 Apr 2. — View Citation

Ma DY, Tan BX, Liu M, Li XF, Zhou YQ, Lu Y. Concurrent three-dimensional conformal radiotherapy and chemotherapy for postoperative recurrence of mediastinal lymph node metastases in patients with esophageal squamous cell carcinoma: a phase 2 single-instit — View Citation

Nakagawa S, Kanda T, Kosugi S, Ohashi M, Suzuki T, Hatakeyama K. Recurrence pattern of squamous cell carcinoma of the thoracic esophagus after extended radical esophagectomy with three-field lymphadenectomy. J Am Coll Surg. 2004 Feb;198(2):205-11. — View Citation

Nakamura T, Ota M, Narumiya K, Sato T, Ohki T, Yamamoto M, Mitsuhashi N. Multimodal treatment for lymph node recurrence of esophageal carcinoma after curative resection. Ann Surg Oncol. 2008 Sep;15(9):2451-7. doi: 10.1245/s10434-008-0016-x. Epub 2008 Jul 1. — View Citation

Rice TW, Rusch VW, Apperson-Hansen C, Allen MS, Chen LQ, Hunter JG, Kesler KA, Law S, Lerut TE, Reed CE, Salo JA, Scott WJ, Swisher SG, Watson TJ, Blackstone EH. Worldwide esophageal cancer collaboration. Dis Esophagus. 2009;22(1):1-8. doi: 10.1111/j.1442-2050.2008.00901.x. — View Citation

Shioyama Y, Nakamura K, Ohga S, Nomoto S, Sasaki T, Yamaguchi T, Toba T, Yoshitake T, Terashima H, Honda H. Radiation therapy for recurrent esophageal cancer after surgery: clinical results and prognostic factors. Jpn J Clin Oncol. 2007 Dec;37(12):918-23. doi: 10.1093/jjco/hym138. — View Citation

Stahl M, Stuschke M, Lehmann N, Meyer HJ, Walz MK, Seeber S, Klump B, Budach W, Teichmann R, Schmitt M, Schmitt G, Franke C, Wilke H. Chemoradiation with and without surgery in patients with locally advanced squamous cell carcinoma of the esophagus. J Cli — View Citation

Yuan G, Wu L, Huang M, Li N, An J. A phase II study of concurrent chemo-radiotherapy with weekly nedaplatin in advanced squamous cell carcinoma of the uterine cervix. Radiat Oncol. 2014 Feb 18;9:55. doi: 10.1186/1748-717X-9-55. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall response rate	RECIST (Response Evaluation Criteria in Solid Tumors) was used to determine the tumor response. Tumor response was evaluated by CT 8 weeks after chemoradiotherapy.	within 8 weeks after the treatment(plus or minus 5 days)	No
Secondary	safety: Toxicity was graded according to the Common Terminology Criteria for Adverse Events (CTCAE v3.0).	A 3 years follow-up from the enrollment or to the date of death from any cause or date of lost follow-up	up to 3 years	Yes
Secondary	overall survival	A 3 years follow-up from the enrollment or to the date of death from any cause or date of lost follow-up	up to 3 years	No