Sequential Paclitaxel Chemotherapy and Radiotherapy as 1st Line Treatment for Elderly Esophageal Squamous Cell Cancer

NCT02016287 | Unknown Phase 2 DMC

• 1 other identifier: CGOG7002
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Elderly patients with metastatic esophageal squamous cell carcinomas have poor prognosis and majority of them were intolerable to combined chemotherapy in China. In the investigators phase II clinical trial proceeded before, the paclitaxel treatment showed good tolerance and efficacy to esophageal squamous cell carcinomas. Radiotherapy has been indicated as a definitive treatment for unresectable or medically inoperable tumors in ESCC patients. However, not only the combination with chemotherapy, but also the boundaries of the clinical target volume (CTV) are not internationally defined. The investigators then initiated a prospective phase II clinical trial with sequential paclitaxel/cisplatin and radiotherapy as the 1st line treatment in elderly metastatic esophageal carcinoma to observe the efficacy and safety of the combination.

Conditions

Esophageal Squamous Cell Cancer; Elderly Patients

Outcome Measures

Primary Outcomes (1)

• progression free survival

  the follow-up visit of PFS will be performed every 2 cycles

  1 year

Secondary Outcomes (1)

• overall survival

  2 years

Other Outcomes (3)

• disease control rate

  1 year

• adverse events

  2 years

• quality of life

  2 years

Study Arms (1)

sequential treatment

EXPERIMENTAL

paclitaxel treatment and radiotherapy

Other: Sequential chemotherapy （paclitaxel 80mg/m2 d1,d8) and radiotherapy

Interventions

Sequential chemotherapy （paclitaxel 80mg/m2 d1,d8) and radiotherapy OTHER

Sequential paclitaxel chemotherapy and radiotherapy

sequential treatment

Eligibility Criteria

• Age: 69 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Having signed informed consent Age more than 69 years old
• Histologically confirmed esophageal squamous carcinoma,metastatic disease with primary tumor,no prior palliative chemotherapy;
• No prior radiotherapy except radiotherapy at non-target lesion of the study more than 3 months
• Sex is not limited
• Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)
• Karnofsky performance status ≥80
• Life expectancy of ≥ 3 month
• WBC \> 3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet \> 100,000/mm3, Hb \> 9g/dl(within 14 days before enrollment),ALT and AST \< 1.5 times ULN (≤5 times ULN in patients with liver metastases),Bilirubin level \< 1.0 times ULN,Serum AKP \< 2.5 times ULN,Serum creatinine \< 1.0 times ULN
• No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever \> 38℃；
• Normal ECG and heart function
• Fertile patients must use effective contraception Good compliance

You may not qualify if:

• Previous treatment of palliative chemotherapy
• Known hypersensitivity to Paclitaxel,Cisplatin
• Only with Brain or bone metastasis
• No measurable lesions, eg. pleural fluid and ascites
• Suffer from severe heart disease or disease with other important organs Chronic diarrhea or renal dysfunction
• Other previous malignancy within 5 year, except non-melanoma skin cancer
• Mentally abnormal or disable cognition,including CNS metastasis

Sponsors & Collaborators

• Shen Lin: lead

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Lin Shen, MD

  Peking Universtiy Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Shen, MD

CONTACT

86-10-88196561; lin100@medmail.com.cn

Zhihao Lu, MD

CONTACT

86-10-88196561; pppeirain@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 7, 2013
• First Posted: December 19, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: July 1, 2016
• Last Updated: December 19, 2013

Record last verified: 2013-12

Locations

CN (1)