Neoplasms Clinical Trial
Official title:
Randomised Phase III Trial of Chemoradiotherapy With or Without Paclitaxel in Patients With Squamous-cell Anal Cancer
The purpose of this study is to determine whether the combination of paclitaxel, capecitabine, mitomycin and intensity-modulated radiotherapy is more effective than the standard combination of capecitabine, mitomycin and intensity-modulated radiotherapy (IMRT) in patients with squamous-cell anal cancer.
This trial aims to investigate the efficacy of chemoradiotherapy with or without paclitaxel in squamous-cell anal cancer. This is a prospective multicenter open-label randomized phase III clinical trial. Patients will be randomized using an online randomization system to receive either standard IMRT with capecitabine and mitomycin or IMRT with capecitabine, mitomycin and paclitaxel. A stratification will be performed based on T stage, N stage and clinical center. Doses of capecitabine and mitomycin in experimental group were reduced for better treatment tolerance. The target accrual is 157 patients in each treatment arm (including 10% potential data loss) based on potential benefit of 15% 3-yr disease-free survival (70% vs 85%), α=0,05, power 80% in the experimental arm. An interim analysis is planned after 50% of the patients will reach a 3-year followup. Pelvic Magnetic Resonance Imaging (MRI) is performed in all patients for staging and followup. Pelvic MRI and histological diagnosis are subject to central review. Conduction of this study and data collection are controlled by a local institutional board. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03826043 -
THrombo-Embolic Event in Onco-hematology
|
N/A | |
| Terminated |
NCT03166631 -
A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread
|
Phase 1 | |
| Completed |
NCT01938846 -
BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT06058312 -
Individual Food Preferences for the Mediterranean Diet in Cancer Patients
|
N/A | |
| Completed |
NCT03308942 -
Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants
|
Phase 2 | |
| Recruiting |
NCT06018311 -
Exercising Together for Hispanic Prostate Cancer Survivor-Caregiver Dyads
|
N/A | |
| Withdrawn |
NCT05431439 -
Omics of Cancer: OncoGenomics
|
||
| Completed |
NCT01343043 -
A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma
|
Phase 1 | |
| Completed |
NCT01938638 -
Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced Cancer
|
Phase 1 | |
| Recruiting |
NCT05514444 -
Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001)
|
Phase 1 | |
| Recruiting |
NCT02292641 -
Beyond TME Origins
|
N/A | |
| Terminated |
NCT00954512 -
Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004)
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04958239 -
A Study to Test Different Doses of BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors)
|
Phase 1 | |
| Recruiting |
NCT04627376 -
Multimodal Program for Cancer Related Cachexia Prevention
|
N/A | |
| Completed |
NCT01222728 -
Using Positron Emission Tomography to Predict Intracranial Tumor Growth in Neurofibromatosis Type II Patients
|
||
| Recruiting |
NCT06004440 -
Real World Registry for Use of the Ion Endoluminal System
|
||
| Active, not recruiting |
NCT05636696 -
COMPANION: A Couple Intervention Targeting Cancer-related Fatigue
|
N/A | |
| Not yet recruiting |
NCT06035549 -
Resilience in East Asian Immigrants for Advance Care Planning Discussions
|
N/A | |
| Recruiting |
NCT06004466 -
Noninvasive Internal Jugular Venous Oximetry
|
||
| Not yet recruiting |
NCT02806557 -
Profiling Neutrophil Counts in Patients on Chemotherapy
|
N/A |