Squamous Cell Carcinoma of Esophagus Clinical Trial
Official title:
Phase II Trial of Cetuximab, Irinotecan, Cisplatin (CPC), Concurrent Radiation Therapy, and Surgery for Resectable Esophageal Cancer
The purpose of this study is to find out what effects (good and bad) the combination of three chemotherapy drugs (cetuximab, cisplatin, and irinotecan) have on esophageal cancer when given with radiation therapy.
- Patients participating in this study must have a tumor biopsy taken to confirm the type
of tumor.
- Outpatient therapy with cetuximab alone will be given intravenously on week 0.
- During week 1-8 outpatient radiation therapy will be started and continued once per day
for 28 treatments or 5 1/2 weeks.
- Outpatient chemotherapy (cisplatin, irinotecan and cetuximab) is given once per week on
weeks 1, 2, 4, and 5. Cetuximab alone will be given on weeks 3, 6, 7, and 8.
- A repeat CT scan and PET scan will be performed to restage the tumor on week 8. This is
to confirm that the cancer has remained localized.
- Inpatient surgery is scheduled 4 to 8 weeks after completion of chemotherapy and
radiation therapy.
- Cetuximab will be restarted within 4 weeks after surgery and continue weekly for 6
months.
- During chemotherapy and radiation therapy, physical exams and vital signs will be
performed before each chemotherapy treatment. Routine blood tests will also be
performed.
- Between chemotherapy-radiation therapy and surgery a CAT scan of chest, abdomen and
pelvis along with a PET scan will be performed.
- After surgery a CAT scan of chest, abdomen and pelvis will be performed every 3 months
for 2 years then every 6 months for 3 years. An EGD (upper endoscopy) with biopsy will
be done every 6 months for 2 years and then yearly for 3 years. Physical exam, vital
signs and routine blood tests will be done every 2 weeks for 6 months, then every 3
months for 1.5 years, and then every 6 months for 3 years.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05759325 -
An Exploratory Study of ctDNA-MRD in Predicting the Efficacy of Esophageal Squamous Cell Carcinoma
|
||
| Completed |
NCT04196075 -
The Effect of Andrographis Paniculata (AP) on Palliative Management of Advanced Esophageal Cancer
|
Phase 3 | |
| Active, not recruiting |
NCT02353936 -
A Phase II Trial of Afatinib in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of Esophagus
|
Phase 2 | |
| Withdrawn |
NCT02033538 -
Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel in Squamous Cell Carcinoma of Esophagus
|
Phase 2 | |
| Terminated |
NCT01248299 -
Benefit of Chemotherapy Over Best Supportive Care in Metastatic and Squamous Cell-type Esophageal Cancer.
|
Phase 2 | |
| Withdrawn |
NCT02041819 -
Neoadjuvant Chemotherapy of Nimotuzumab Plus Nab-Paclitaxel in Squamous Cell Carcinoma of Esophagus
|
Phase 2 |