Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05660616 |
| Other study ID # |
SMGFM |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2023 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
February 2023 |
| Source |
Ain Shams University |
| Contact |
Abanoub Samir |
| Phone |
0201002869267 |
| Email |
abanoob_sk[@]yahoo.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Mesothelioma is an aggressive form of cancer. Treatments are available, but for many people,
a cure isn't possible.
This thesis is to assess the efficacy and safety of switch-maintenance Gemcitabine in
Mesothelioma patients after first line chemotherapy (Pemetrexed-Platinum)
Description:
Malignant pleural mesothelioma is a rare but aggressive cancer of the pleural lining.
Malignant pleural mesothelioma accounted for 30,870 new cancer cases and 26,278 deaths
worldwide in 2020.
In Egypt, Malignant pleural mesothelioma accounted for 337 new cases and 307 deaths in 2020.
Long-term exposure to asbestos is a well-established risk factor for Malignant pleural
mesothelioma. It accounts for almost 80% of cases.
Malignant pleural mesothelioma is classified into three histologic subtypes: epithelioid,
sarcomatoid, and biphasic. Epithelioid histology confers the most favorable prognosis and
sarcomatoid the least.
The majority of patients with Malignant pleural mesothelioma present with breathlessness,
chest pain or both. Other symptoms include fatigue, anorexia, weight loss, sweats and
malaise.
Radiological imaging should be undertaken in all patients as it can provide valuable
diagnostic and staging information. Further investigation of suspected Malignant pleural
mesothelioma requires sampling of pleural fluid for biochemical and cytological examination.
Biopsies are usually required to confirm the diagnosis and identify the histological
sub-type.
Patients with Malignant pleural mesothelioma should be managed by an experienced
multidisciplinary team. Treatment options include surgery, radiation therapy and
chemotherapy.
Front line polychemotherapy is considered the standard of care, whereas single agent
chemotherapy has shown limited efficacy with disappointing response rates.
A pivotal trial led to the establishment of Cisplatin and Pemetrexed as standard first line
regimen for unresectable Malignant pleural mesothelioma.
A recent phase II trial from Cancer and Leukemia Group B showed that maintenance Pemetrexed
after 4 to 6 cycles of doublet chemotherapy induction did not prolong progression free
survival over placebo.
Adding Bevacizumab to first line platinum doublet resulted in an overall survival and
progression free survival gain in the phase III French trial MAPS .Bevacizumab was continued
as maintenance every three weeks following completion of six cycles of chemotherapy.
In a phase III trial NVALT 5 , Thalidomide versus active supportive care for maintenance in
patients with malignant mesothelioma after first-line chemotherapy showed no benefit in time
to progression.
First line Nivolumab plus Ipilimumab in phase III trial checkmate 743 provided significant
and clinically meaningful improvements in overall survival versus standard of care
chemotherapy.
Unfortunately, nearly all patients progress during or after first-line therapy, and no
standard second line recommended treatments exist after platinum based regimen. Retreatment
with pemetrexed, eventually associated with platinum compound, may be offered in patients who
achieved durable disease control more than 6 months with first line chemotherapy.
Single agent chemotherapy with Vinorelbine or Gemcitabine is the preferred choice as second
line treatment , mainly based on retrospective analyses or small phase II trials.
