Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402708
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-05-03
Brief Title:
Postoperative Adjuvant Chemotherapy for Thymic Cancer FUSCC-Thymic 3
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Postoperative Adjuvant Treatment for Thymic Cancer With Completed Resection Radiotherapy vs Chemoradiotherapy A Prospective Multicenter Open-label Phase III Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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:
The goal of this clinical trial is to learn the role of adjuvant chemotherapy for patients with thymic carcinoma and completed resection The main questions it aims to answer are
1 Does adjuvant chemotherapy decrease disease progression
2 Does medium dose of three drugs paclitaxel cisplatin 5-FU well tolerance
Researchers will compare chemoradiotherapy to radiotherapy to see whether chemoradiotherapy could decrease disease progression or not
Participants will
1 Take radiotherapy 50Gy25f with or without 4 cycles of chemotherapy TPF
2 Follow up every 3 months in the first two year and then every 6 months
1 Does adjuvant chemotherapy decrease disease progression
2 Does medium dose of three drugs paclitaxel cisplatin 5-FU well tolerance
Researchers will compare chemoradiotherapy to radiotherapy to see whether chemoradiotherapy could decrease disease progression or not
Participants will
1 Take radiotherapy 50Gy25f with or without 4 cycles of chemotherapy TPF
2 Follow up every 3 months in the first two year and then every 6 months
Detailed Description:
Thymic carcinomas are rare neoplasms found in the anterior mediastinum with an incidence of 038 cases per 100000 people Surgery is the primary treatment for patients with thymic carcinomas and complete surgical resection proves fundamental for enhancing survival However the necessity for adjuvant therapy and the optimal type thereof for patients who have undergone complete resection remain unclear due to the lack of high-quality studies
Our previous retrospective study found that radiotherapy improved overall survival and disease progression free survival significantly for all patients with thymic carcinoma and completed resection however chemotherapy only improved disease progression free survival for patients of stage IIIIV We also found that chemotherapy regimens containing paclitaxel were an advantageous combination for thymic cancer and 1 or 2 cycles of adjuvant chemotherapy were better than more cycles suggesting reduced dose chemotherapy
DCF docetaxel cisplatin 5-FU or TPF paclitaxel cisplatin 5-FU were widely used in head and neck esophageal stomach and anal canal cancer and better effect were presented However the toxicity of full dose was too toxic to tolerate Our previous experience in esophageal cancer found TPF with 23 of standard dose was well tolerance Therefore medium dose of TPF three drugs chemotherapy were chosed to balance efficacy and toxicity
Our previous retrospective study found that radiotherapy improved overall survival and disease progression free survival significantly for all patients with thymic carcinoma and completed resection however chemotherapy only improved disease progression free survival for patients of stage IIIIV We also found that chemotherapy regimens containing paclitaxel were an advantageous combination for thymic cancer and 1 or 2 cycles of adjuvant chemotherapy were better than more cycles suggesting reduced dose chemotherapy
DCF docetaxel cisplatin 5-FU or TPF paclitaxel cisplatin 5-FU were widely used in head and neck esophageal stomach and anal canal cancer and better effect were presented However the toxicity of full dose was too toxic to tolerate Our previous experience in esophageal cancer found TPF with 23 of standard dose was well tolerance Therefore medium dose of TPF three drugs chemotherapy were chosed to balance efficacy and toxicity
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