Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003652
Status:
COMPLETED
Last Update Posted:
2021-02-17
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Intensification Therapy for Locally Advanced Epidermoid Cancer of the Anal Canal - Phase III Intergroup Study
Status:
COMPLETED
Status Verified Date:
2021-02
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 Combining chemotherapy with radiation therapy may kill more tumor cells
PURPOSE This randomized phase III trial is studying different regimens of giving combination chemotherapy together with radiation therapy and comparing how well they work in treating patients with stage II or stage III anal cancer
PURPOSE This randomized phase III trial is studying different regimens of giving combination chemotherapy together with radiation therapy and comparing how well they work in treating patients with stage II or stage III anal cancer
Detailed Description:
OBJECTIVES
Compare the efficacy of concurrent chemotherapy and radiotherapy with or without neoadjuvant chemotherapy with fluorouracil and cisplatin in patients with stage II or III anal canal cancer
Compare the efficacy of two levels of radiation dose in patients with stage II or III anal canal cancer
Compare the sphincter conservation of the anus by these regimens
Compare the effect of these regimens on survival and quality of life of these patients
OUTLINE This is a randomized multicenter study
Patients are randomized to one of four treatment arms
Arm I Patients receive induction chemotherapy consisting of fluorouracil IV over 24 hours on days 1-4 and cisplatin IV over 1 hour on day 1 or 2 every 4 weeks for 2 courses Beginning 4 weeks later patients receive chemoradiotherapy This regimen consists of fluorouracil IV over 24 hours on days 1-4 and cisplatin IV over 1 hour on day 1 or 2 and repeated 4 weeks later plus pelvic radiotherapy beginning on day 1 and continuing for 5 weeks once a day 5 daysweek Patients receive low dose radiotherapy directly to the tumor beginning 3 weeks later and continuing for 2 weeks
Arm II Patients receive induction chemotherapy and chemoradiotherapy as in arm I plus high dose radiotherapy directly to the tumor
Arm III control arm Patients receive chemoradiotherapy and low dose radiotherapy to the tumor as in arm I
Arm IV Patients receive chemoradiotherapy and high dose radiotherapy to the tumor as in arm II
After study treatment is completed patients with nonfixed inguinal tumors may undergo surgical resection followed by radiotherapy or radiotherapy alone Patients with fixed inguinal tumors may receive further radiotherapy alone
Quality of life is assessed before treatment at 2 months after completion of treatment and at 5 years
Patients are followed every 4 months for 2 years every 6 months for 3 years then annually thereafter
PROJECTED ACCRUAL A total of 350 patients will be accrued for this study within 4 years
Compare the efficacy of concurrent chemotherapy and radiotherapy with or without neoadjuvant chemotherapy with fluorouracil and cisplatin in patients with stage II or III anal canal cancer
Compare the efficacy of two levels of radiation dose in patients with stage II or III anal canal cancer
Compare the sphincter conservation of the anus by these regimens
Compare the effect of these regimens on survival and quality of life of these patients
OUTLINE This is a randomized multicenter study
Patients are randomized to one of four treatment arms
Arm I Patients receive induction chemotherapy consisting of fluorouracil IV over 24 hours on days 1-4 and cisplatin IV over 1 hour on day 1 or 2 every 4 weeks for 2 courses Beginning 4 weeks later patients receive chemoradiotherapy This regimen consists of fluorouracil IV over 24 hours on days 1-4 and cisplatin IV over 1 hour on day 1 or 2 and repeated 4 weeks later plus pelvic radiotherapy beginning on day 1 and continuing for 5 weeks once a day 5 daysweek Patients receive low dose radiotherapy directly to the tumor beginning 3 weeks later and continuing for 2 weeks
Arm II Patients receive induction chemotherapy and chemoradiotherapy as in arm I plus high dose radiotherapy directly to the tumor
Arm III control arm Patients receive chemoradiotherapy and low dose radiotherapy to the tumor as in arm I
Arm IV Patients receive chemoradiotherapy and high dose radiotherapy to the tumor as in arm II
After study treatment is completed patients with nonfixed inguinal tumors may undergo surgical resection followed by radiotherapy or radiotherapy alone Patients with fixed inguinal tumors may receive further radiotherapy alone
Quality of life is assessed before treatment at 2 months after completion of treatment and at 5 years
Patients are followed every 4 months for 2 years every 6 months for 3 years then annually thereafter
PROJECTED ACCRUAL A total of 350 patients will be accrued for this study within 4 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| FNCLCC-FFCD-SFRO-ACCORD-3 | None | None | None |
| EU-98050 | None | None | None |