Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003118
Status:
COMPLETED
Last Update Posted:
2016-07-04
First Post:
1999-11-01
Brief Title:
Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Prospective Randomized Phase III Trial Comparing Trimodality Therapy Cisplatin 5-FU Radiotherapy and Surgery to Surgery Alone for Esophageal Cancer
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells It is not yet known whether surgery is more effective with or without chemotherapy and radiation therapy for cancer of the esophagus
PURPOSE Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy and radiation therapy in treating patients who have cancer of the esophagus that can be surgically removed
PURPOSE Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy and radiation therapy in treating patients who have cancer of the esophagus that can be surgically removed
Detailed Description:
OBJECTIVES I Compare overall five-year survival rates and treatment failures in patients receiving neoadjuvant cisplatin CDDP plus fluorouracil 5-FU with concomitant radiotherapy followed by surgical resection versus patients receiving surgery alone II Assess and compare the toxicities of each approach III Compare the incidence and pattern of local gastric or esophageal bed or regional lymph nodes and distant supraclavicular lymph node liver peritoneal carcinomatosis or lung brain etc recurrence IV Evaluate the prognostic ability of noninvasive and minimally invasive pretreatment staging with regard to survival and recurrence V Evaluate the ability of preresection adjuvant chemotherapy with concomitant radiation therapy to render tumors to lower stages VI Evaluate the impact of lymph nodes on survival and recurrence
OUTLINE This a two arm randomized study Patients are stratified by cell type of cancer squamous cell vs adenocarcinoma lymph nodes positive vs negative and stage invasive vs noninvasive Patients in arm I undergo chemotherapy and radiotherapy within 24 hours of each other Chemotherapy consists of cisplatin CDDP by bolus IV infusion over 30 minutes on day 1 and again on day 29 Fluorouracil 5-FU is administered by continuous IV infusion for 4 days on days 1-4 and 29-32 after completion of cisplatin Radiotherapy is administered on days 1-5 8-12 15-19 22-26 and 29-33 with a boost on days 36-38 If there is no disease progression or unresectable disease surgery is performed within 3-8 weeks following completion of therapy Patients in arm II undergo surgery alone no later than 6 weeks postrandomization Patients are followed at least every 3 months for two years then every 6 months for the next two years and annually thereafter
OUTLINE This a two arm randomized study Patients are stratified by cell type of cancer squamous cell vs adenocarcinoma lymph nodes positive vs negative and stage invasive vs noninvasive Patients in arm I undergo chemotherapy and radiotherapy within 24 hours of each other Chemotherapy consists of cisplatin CDDP by bolus IV infusion over 30 minutes on day 1 and again on day 29 Fluorouracil 5-FU is administered by continuous IV infusion for 4 days on days 1-4 and 29-32 after completion of cisplatin Radiotherapy is administered on days 1-5 8-12 15-19 22-26 and 29-33 with a boost on days 36-38 If there is no disease progression or unresectable disease surgery is performed within 3-8 weeks following completion of therapy Patients in arm II undergo surgery alone no later than 6 weeks postrandomization Patients are followed at least every 3 months for two years then every 6 months for the next two years and annually thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA031946 | NIH | None | None |
| CDR0000065873 | REGISTRY | NCI Physician Desk Reference | httpsreporternihgovquickSearchU10CA031946 |
| CLB-C9781 | None | None | None |
| E-C9781 | None | None | None |
| NCCTG-C9781 | None | None | None |
| RTOG-9716 | None | None | None |