Surgery With or Without Radiation Therapy & Chemotherapy in Treating

Status Completed

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy with radiation therapy before surgery may shrink the tumor so it can be removed during surgery. It is not yet known if surgery is more effective with or without radiation therapy and chemotherapy in treating esophageal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without radiation therapy and chemotherapy in treating patients who have esophageal cancer.

Clinical Trial Description

OBJECTIVES:

- Compare the overall survival of patients with resectable thoracic esophageal cancer treated with neoadjuvant radio-chemotherapy and surgery versus surgery alone.

- Compare the disease-free survival of patients treated with these regimens.

- Compare the surgical mortality and morbidity of patients treated with these regimens.

- Compare the resectability of patients treated with these regimens.

- Determine the validation of new prognostic factors for survival of these patients and/or the efficacy of this neoadjuvant treatment.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to histology (epidermoid carcinoma vs adenocarcinoma vs undifferentiated carcinoma), stage (I vs IIA vs IIB), tumor location (above the carina vs below the carina), and participating center. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo radiotherapy daily 5 days a week for 5 weeks. Patients receive fluorouracil IV continuously on days 1-4 and 29-32 and cisplatin IV on days 1 or 2 and 29 or 30 (or a lower dose on days 1-5 and 29-33). Within 4-8 weeks after completion of radio-chemotherapy, patients undergo surgical resection.

- Arm II: Patients undergo surgical resection. Patients are followed every 4 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 380 patients (190 per treatment arm) will be accrued for this study within 3 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00047112
Study type	Interventional
Source	Federation Francophone de Cancerologie Digestive
Contact
Status	Completed
Phase	Phase 3
Start date	May 2002
Completion date	September 2010

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06006390` - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors	Phase 1/Phase 2
Terminated	`NCT01624090` - Mithramycin for Lung, Esophagus, and Other Chest Cancers	Phase 2
Recruiting	`NCT05787522` - Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk
Not yet recruiting	`NCT05542680` - Study on the Design and Application of Special Semi Recumbent Cushion for Postoperative Patients With Esophageal Cancer	N/A
Completed	`NCT03384511` - The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.	Phase 4
Completed	`NCT00003864` - Docetaxel Plus Carboplatin in Treating Patients With Advanced Cancer of the Esophagus	Phase 2
Recruiting	`NCT05491616` - Nivolumab During Active Surveillance After Neoadjuvant Chemoradiation for Esophageal Cancer: SANO-3 Study	Phase 2
Active, not recruiting	`NCT04383210` - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors	Phase 2
Completed	`NCT00199849` - NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine	Phase 1
Completed	`NCT03756597` - PAN-study: Pan-Cancer Early Detection Study (PAN)
Completed	`NCT00400114` - Sutent Following Chemotherapy, Radiation and Surgery For Resectable Esophageal Cancer	Phase 2
Completed	`NCT03652077` - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies	Phase 1
Recruiting	`NCT04615806` - The Value of Lymph Node Dissection of Indocyanine Green-guided Near-infrared Fluorescent Imaging in Esophagectomy	N/A
Active, not recruiting	`NCT04566367` - Blue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer	N/A
Active, not recruiting	`NCT03962179` - Feasibility and Efficacy of a Combination of a SEMS and Vacuum Wound Treatment (VACStent)	N/A
Terminated	`NCT01446874` - Prevention of Post-operative Pneumonia (POPP)	Phase 2/Phase 3
Completed	`NCT03468634` - Raman Probe for In-vivo Diagnostics (During Oesophageal) Endoscopy	N/A
Active, not recruiting	`NCT02869217` - Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors	Phase 1
Completed	`NCT02810652` - Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection	N/A
Recruiting	`NCT02544737` - Apatinib for Metastatic Esophageal Cancer.	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms