ESCC-307PLAH: Paclitaxel Plus Radiation With Erlotinib to Treat Esophageal Squamous Carcinoma

• Sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01752205
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

The purpose of this study is to test the safety and effectiveness of erlotinib and chemoradiotherapy in patients with unresectable esophageal or gastro-esophageal squamous cancer .

Condition or Disease	Intervention/Treatment	Phase
Esophageal Squamous Carcinoma	Drug: Paclitaxel; Drug: Erlotinib; Radiation: Radiation therapy	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Phase III Study: Paclitaxel Plus Radiation Therapy With or Without Erlotinib in Treating Patients With Esophageal Squamous Carcinoma
• Study Start Date: Nov 1, 2012
• Anticipated Primary Completion Date: May 1, 2014
• Anticipated Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Chemoradiotherapy The patients will receive radiation therapy QD, 5 days a week and receive paclitaxel IV ，dosing schedule: 45mg/m2/w.	Drug: Paclitaxel; 45mg/m2/w,total 6 weeks; Radiation: Radiation therapy; Other Names: radiation therapy QD, 5 days a week,95%PTV 60Gy/2Gy/30f,total 6 weeks
Experimental: Erlotinib and chemoradiotherapy The patients will receive radiation therapy QD, 5 days a week and receive paclitaxel IV (45mg/m2/w) and erlotinib PO QD.	Drug: Paclitaxel; 45mg/m2/w,total 6 weeks; Drug: Erlotinib; 150mg/d,days 1-42,total 6 weeks; Radiation: Radiation therapy; Other Names: radiation therapy QD, 5 days a week,95%PTV 60Gy/2Gy/30f,total 6 weeks

Outcome Measures

Primary Outcome Measures

1. Progression free survival [2 year]

Secondary Outcome Measures

1. Tumor response rate [1 year]

2. disease control rate [1 year]

3. overall survival [5 year]

4. adverse events [5 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Histologically confirmed squamous cell carcinoma of esophagus or Esophagogastric Junction

2. Age >= 18

3. ECOG PS 0-2

4. Ineligibility for surgery

5. No prior palliative therapy

6. At least one bidimensionally measurable disease as defined by RECIST ver 1.1

7. Adequate organ function for treatment

• Absolute neutrophil count (ANC)>=1000cells/mm3

• Platelets >=100000 cells/mm3

• Estimated creatinine clearance>=50mL/min, or serum creatinine<1.5 x institution upper limit of normal

• Bilirubin=<1.5 x upper limit of normal(ULN)

• AST(SGOT)=<2.5 x ULN (5.0xULN if hepatic metastases)

• ALT(SGPT)=<2.5 x ULN (5.0xULN if hepatic metastases)

• 12-Lead electrocardiogram(ECG) with normal tracing or non-clinically significant changes that do not require medical intervention

• QTc interval =<470 msec and without history of Torsades de Points or other symptomatic QTc abnormality

• LVEF (by MUGA or echocardiogram) of >=50%.

1. The patient has provided signed informed consent and is amenable to compliance with protocol schedules and testing.

Exclusion Criteria:

1. Previous treatment with small molecule EGFR tyrosine kinase inhibitors

2. Any major operation within 4 weeks of baseline disease assessment

3. Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug

4. CNS metastasis with continuous corticosteroid use within 4 weeks of baseline disease assessment

5. Patients with known interstitial lung disease

6. Patients with uncontrolled or significant cardiovascular disease (AMI within 12 months,Unstable angina within 6 months, NYHA Class III, IV Congestive heart failure or left ventricular ejection fraction below local institutional lower limit of normal or below 45%, Congenital long QT syndrome, Any significant ventricular arrhythmia, Any uncontrolled second or third degree heart block, Uncontrolled hypertension)

7. Previous or concurrent malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 5 years prior to study entry.

8. Pregnant or breast-feeding women

9. Other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into this trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	307 Hospital of PLA	Beijing	Beijing	China

Sponsors and Collaborators

• The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Investigators

• Principal Investigator: Xu jianming, M.D., The Affiliated Hospital of the Chinese Academy of Military Medical Science

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xu jianming, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
• ClinicalTrials.gov Identifier: NCT01752205
• Other Study ID Numbers: ESCC-307PLAH-XJM
• First Posted: Dec 19, 2012
• Last Update Posted: Dec 19, 2012
• Last Verified: Dec 1, 2012

• Keywords provided by Xu jianming, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences: Esophageal Squamous Carcinoma; Erlotinib; Chemoradiotherapy
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Paclitaxel; Erlotinib Hydrochloride

Study Results

No Results Posted as of Dec 19, 2012