Study on FOLFOX6 as First-line Therapy to Treat Recurrent or Metastatic Esophageal Cancer

NCT01605305 | Completed Phase 2 DMC

• 1 other identifier: FOLFOX6-2008
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to explore whether FOLFOX6 as treatment could improve the time to progression (TTP) and overall survival (OS) of the patient with recurrent or metastatic esophagus.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• TPP

  from the first cycle of treatment (day one) to two month after the last cycle

Secondary Outcomes (1)

• OS

  from the first cycle of treatment (day one) to two month after the last cycle

Study Arms (1)

FOLFOX6

EXPERIMENTAL

Drug: FOLFOX6

Interventions

FOLFOX6 DRUG

OXA 100mg/m2 ivgtt 2h d1 LV 400mg/m2 ivgtt 2h d1 5FU 400mg/m2 iv. d1 5FU 2.4g/m2 civ 46h

FOLFOX6

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven primary thoracic esophageal squamous cell carcinoma
• Without chemotherapy or neo-adjuvant chemotherapy in 6 weeks ,radiotherapy has end at least 1 month,target lesion was not in an irradiated area.
• Presence of at least one index lesion measurable by CT scan or MRI
• \~75 years
• kps ≥ 70
• Life expectancy of ≥ 3 months
• ANC ≥ 2×109/L，PLT ≥ 100×109/L，Hb ≥ 90g/L
• Cr ≤ 1.0×UNL
• TB ≤ 1.25×UNL； ALT/AST ≤ 2.5×UNL，THE patient with liver metastasis ALT/AST ≤ 5.0×UNL；AKP ≤ 2.5×UNL
• Signed written informed consent

You may not qualify if:

• Previous exposure to oxa therapy in one year
• diameter of tumor abdominal ≥ 10cm, Total volumes of liver lesions ≥ 50%,lung metastasis ≥ 25% total lung
• chronic diarrhea,enteritis,intestine obstruction which are not under control
• Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol.
• peripheral neuropathy ≥ CTCAE 1
• Other serious disease
• Previous or concomitant malignancies except non-melanoma skin cancer, carcinoma in situ of the cervix, and invasive carcinoma of the colon, thyroid, cervix, or endometrium treated five years prior to study entry.
• USE OTHER ANTITUMOR THERAPY
• Breast-feeding or pregnant women, no effective contraception if risk of conception exists

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Folfox protocol

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

Study Officials

• chang j h, post-doctor

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: May 22, 2012
• First Posted: May 24, 2012
• Study Start: September 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: May 24, 2012

Record last verified: 2012-05