Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033657
Status:
COMPLETED
Last Update Posted:
2023-06-28
First Post:
2002-04-09
Brief Title:
Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Randomized Phase II Study of Preoperative Combined Modality Paclitaxel Cisplatin RT or Irinotecan Cisplatin RT Followed by Postoperative Chemotherapy With the Same Agents in Operable Adenocarcinoma of the Esophagus
Status:
COMPLETED
Status Verified Date:
2023-06
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 Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining radiation therapy with chemotherapy before and after surgery may kill more tumor cells
PURPOSE Randomized phase II trial to compare the effectiveness of combining radiation therapy with two different chemotherapy regimens before and after surgery in treating patients who have esophageal cancer
PURPOSE Randomized phase II trial to compare the effectiveness of combining radiation therapy with two different chemotherapy regimens before and after surgery in treating patients who have esophageal cancer
Detailed Description:
OBJECTIVES
Compare the pathologic complete response rate in patients with adenocarcinoma of the esophagus or gastroesophageal junction treated with radiotherapy with pre- and post-operative cisplatin plus paclitaxel versus cisplatin plus irinotecan
Compare the survival outcome in patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the tolerability of these adjuvant chemotherapy regimens after neoadjuvant chemoradiotherapy in these patients
Compare time to progression or recurrence in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to ECOG performance status 0 vs 1 and stage of disease T2-3 N0 M0 vs T1-3 N0-1 M0 or M1A Patients are randomized to 1 of 2 treatment arms
Arm A Patients receive neoadjuvant radiotherapy once daily 5 days a week for 5 weeks beginning on day 1 concurrently with neoadjuvant chemotherapy comprising cisplatin IV Intravenous over 2-3 hours followed by irinotecan IV over 30-60 minutes once daily on days 1 8 22 and 29 Four to six weeks after completion of neoadjuvant chemoradiotherapy patients undergo surgical resection A minimum of 4 weeks after resection patients receive adjuvant chemotherapy comprising cisplatin and irinotecan as above on days 1 and 8 Treatment with adjuvant chemotherapy repeats every 3 weeks for 3 courses
Arm B Patients receive neoadjuvant radiotherapy as in arm A concurrently with neoadjuvant chemotherapy comprising paclitaxel IV Intravenous over 1 hour followed by cisplatin IV over 2-3 hours once daily on days 1 8 15 22 and 29 Patients then undergo surgical resection as in arm A A minimum of 4 weeks after resection patients receive adjuvant chemotherapy comprising paclitaxel IV over 3 hours followed by cisplatin as above on day 1 Treatment with adjuvant chemotherapy repeats every 3 weeks for 3 courses
In both arms treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed at 1 month every 3 months for 2 years every 6 months for 3 years and then annually for 5 years
ACCRUAL A total of 97 patients 50 on Arm A and 47 on Arm B were accrued for this study
Compare the pathologic complete response rate in patients with adenocarcinoma of the esophagus or gastroesophageal junction treated with radiotherapy with pre- and post-operative cisplatin plus paclitaxel versus cisplatin plus irinotecan
Compare the survival outcome in patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the tolerability of these adjuvant chemotherapy regimens after neoadjuvant chemoradiotherapy in these patients
Compare time to progression or recurrence in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to ECOG performance status 0 vs 1 and stage of disease T2-3 N0 M0 vs T1-3 N0-1 M0 or M1A Patients are randomized to 1 of 2 treatment arms
Arm A Patients receive neoadjuvant radiotherapy once daily 5 days a week for 5 weeks beginning on day 1 concurrently with neoadjuvant chemotherapy comprising cisplatin IV Intravenous over 2-3 hours followed by irinotecan IV over 30-60 minutes once daily on days 1 8 22 and 29 Four to six weeks after completion of neoadjuvant chemoradiotherapy patients undergo surgical resection A minimum of 4 weeks after resection patients receive adjuvant chemotherapy comprising cisplatin and irinotecan as above on days 1 and 8 Treatment with adjuvant chemotherapy repeats every 3 weeks for 3 courses
Arm B Patients receive neoadjuvant radiotherapy as in arm A concurrently with neoadjuvant chemotherapy comprising paclitaxel IV Intravenous over 1 hour followed by cisplatin IV over 2-3 hours once daily on days 1 8 15 22 and 29 Patients then undergo surgical resection as in arm A A minimum of 4 weeks after resection patients receive adjuvant chemotherapy comprising paclitaxel IV over 3 hours followed by cisplatin as above on day 1 Treatment with adjuvant chemotherapy repeats every 3 weeks for 3 courses
In both arms treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed at 1 month every 3 months for 2 years every 6 months for 3 years and then annually for 5 years
ACCRUAL A total of 97 patients 50 on Arm A and 47 on Arm B were accrued for this study
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 |
|---|---|---|---|
| E1201 | OTHER | Eastern Cooperative Oncology Group ECOG | httpsreporternihgovquickSearchU10CA021115 |
| U10CA021115 | NIH | None | None |