Combination Chemotherapy + Radiation for Esophageal Cancer
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Massachusetts General Hospital
Must not be taking: Cimetidine
Disqualifiers: Metastatic disease, Prior chemotherapy, Cardiac morbidity, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?In this research study, is studying how Liposomal Irinotecan in combination with the standard of care interventions FOLFOX, carboplatin paclitaxel, and radiation therapy affect gastroesophageal junction or esophagogastric cancer
This research study involves the following study intervention:
- Liposomal irinotecan
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot take cimetidine during the study. You might need to switch to another similar medication before starting the trial.
What data supports the effectiveness of the treatment Combination Chemotherapy + Radiation for Esophageal Cancer?
Research shows that combining chemotherapy drugs like paclitaxel and carboplatin with radiation therapy can improve outcomes for patients with esophageal cancer. Studies have found that this combination can be effective in treating both advanced and localized forms of the disease.
12345Is the combination of chemotherapy and radiation therapy safe for treating esophageal cancer?
Studies have shown that combining chemotherapy drugs like carboplatin and paclitaxel with radiation therapy is generally safe for treating esophageal cancer, though some patients may experience side effects like neutropenia (low white blood cell count) and esophagitis (inflammation of the esophagus).
36789What makes the combination chemotherapy and radiation treatment for esophageal cancer unique?
This treatment is unique because it combines multiple chemotherapy drugs, including carboplatin, FOLFOX, liposomal irinotecan, and paclitaxel, with radiation therapy, which is not a standard combination. The inclusion of newer agents like liposomal irinotecan and the specific combination of these drugs with radiation therapy may offer promising antitumor activity and better therapy tolerance.
310111213Eligibility Criteria
This trial is for adults over 18 with a specific type of esophageal or gastroesophageal junction cancer, confirmed by pathology. They must have an ECOG performance status ≤1 (which means they are fully active or restricted in physically strenuous activity but can do light work), a life expectancy over 3 months, and adequate organ/marrow function. Women who can bear children need a negative pregnancy test and agree to use contraception during the study.Inclusion Criteria
Ability to understand and the willingness to sign a written informed consent document.
absolute neutrophil count ≥ 1,500 cells/mm3
My organs and bone marrow are working well.
+11 more
Exclusion Criteria
I am allergic to certain chemotherapy drugs like 5-fluorouracil, irinotecan, or oxaliplatin.
I have received treatments like chemotherapy or radiation for my esophagogastric cancer.
I am not taking cimetidine but can use other stomach acid reducers.
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive FOLFOX with nal-IRI for eight two-week cycles (16 weeks total)
16 weeks
8 visits (in-person)
Chemoradiation
Participants receive chemoradiation with proton or photon radiation therapy concurrent with weekly Paclitaxel and Carboplatin
5 weeks
5 visits (in-person)
Surgery
Participants undergo surgery following chemoradiation
Follow-up
Participants are monitored for safety and effectiveness after treatment
5 years
Participant Groups
The trial tests Liposomal Irinotecan combined with standard treatments: FOLFOX (a chemotherapy regimen), carboplatin, paclitaxel, and radiation therapy on patients with gastroesophageal junction or esophagogastric cancer. The goal is to see how this combination affects their cancer.
1Treatment groups
Experimental Treatment
Group I: FOLFOX/ nal-IRIExperimental Treatment4 Interventions
Treatment will be administered on an outpatient basis.
* FOLFOX with nal-IRI for eight two-week cycles (16 weeks total)
* Chemoradiation with proton or photon radiation therapy concurrent with weekly Paclitaxel and Carboplatin for 5 weeks
* Surgery
Carboplatin is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Paraplatin for:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
🇪🇺 Approved in European Union as Carboplatin for:
- Ovarian cancer
- Small cell lung cancer
🇨🇦 Approved in Canada as Carboplatin for:
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Massachusetts General HospitalBoston, MA
Beth-Israel Deaconess Medical CenterBoston, MA
Massachusetts General Hospital at Newton Wellesley HospitalNewton, MA
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Who Is Running the Clinical Trial?
Massachusetts General HospitalLead Sponsor
IpsenIndustry Sponsor
References
Neoadjuvant chemoradiotherapy for esophageal cancer using weekly Paclitaxel and Carboplatin plus infusional 5-Fluorouracil. [2022]To evaluate neoadjuvant therapy with weekly paclitaxel/carboplatin plus 5-fluorouracil (5-FU) with conformal radiotherapy in a phase II trial in resectable esophageal carcinoma.
Preoperative combined modality therapy with paclitaxel, carboplatin, prolonged infusion 5-fluorouracil, and radiation therapy in localized esophageal cancer: preliminary results of a Minnie Pearl Cancer Research Network phase II trial. [2015]To evaluate the feasibility, toxicity, and therapeutic efficacy of 1-hour paclitaxel, carboplatin, continuous low-dose infusional 5-fluorouracil, and concurrent radiation therapy administered preoperatively in patients with localized esophageal cancer.
A phase I study of UFT/leucovorin, carboplatin, and paclitaxel in combination with external beam radiation therapy for advanced esophageal carcinoma. [2015]Concurrent chemotherapy and radiation therapy (RT) are used to treat patients with esophageal cancer. The optimal combination of chemotherapeutic agents with RT is not well established. We evaluated the safety and preliminary efficacy of a combination of UFT/leucovorin, carboplatin, and paclitaxel with RT in a Phase I study of patients with advanced esophageal cancer.
Concurrent liposomal paclitaxel and cisplatin chemotherapy improved outcomes for locally advanced esophageal squamous cell carcinoma treated with intensity-modulated radiotherapy. [2022]To ascertain whether concurrent chemotherapy using liposomal paclitaxel and cisplatin could improve the outcomes of patients with locally advanced esophageal squamous cell carcinoma receiving intensity-modulated radiotherapy (IMRT).
[News in gastrointestinal radiotherapy: The esophageal cancer]. [2022]Esophageal cancers continue to have a poor prognosis, even if this has improved over the past 25 years due to better management. Pre-operative chemotherapy with Paclitaxel-Carboplatin followed by adjuvant immunotherapy with Nivolumab represents a major advance in the management of locally advanced oesophageal cancer. Pre-operatively, chemo-radiotherapy can be performed in combination with FOLFOX or Paclitaxel-Carboplatin. Several trials are currently ongoing to evaluate the benefit of immunotherapy in non-operable cancers. In contrast, dose escalation in locally advanced non-operable tumors and the combination of pre-operative chemo-radiotherapy with trastuzumab have not been shown to be beneficial.
A Pilot Trial of S-1 and Paclitaxel in Unresectable or Postoperative Recurrent Esophageal Squamous Cell Carcinoma Pretreated by Fluorouracil, Cisplatin, and Docetaxel Chemotherapy. [2019]This study documents the clinical efficacy and toxicity of S-1 and paclitaxel (S1/PTX) in patients with unresectable or postoperative recurrent esophageal squamous cell carcinoma (ESCC) who had been previously treated with fluorouracil (5FU), cisplatin, and docetaxel.
Paclitaxel, cisplatin, and concurrent radiation for esophageal cancer. [2019]Paclitaxel is an active agent for adenocarcinomas and squamous cell carcinomas of the esophagus and is a radiation sensitizer. We sought to investigate the toxicity and complete response rate of paclitaxel, cisplatin, and concurrent radiation for esophageal cancer. Forty-one patients with esophageal cancer were studied, 29 with adenocarcinomas and 12 with squamous cell cancers. Twelve patients had tumor extension into the proximal stomach and/or abdominal adenopathy. Patients received paclitaxel 60 mg/m2 by 3-hour intravenous (i.v.) infusion, and cisplatin 25 mg/m2 weekly on days 1, 8, 15, and 22. Radiation was administered concurrently to a total dose of 39.60 Gy, in 1.80 Gy fractions, for 22 treatments. Patients with medical or surgical contraindications to esophagectomy received 2 additional weeks of paclitaxel with a radiation boost to 50.4 Gy. Neutropenia was the most common grade 3/4 toxicity occurring in 10 patients (24%). Only 2 patients (5%) had grade 4 esophagitis requiring parenteral nutrition. Twelve patients (29%) obtained a complete response. The 2-year progression-free and overall survival rates were 40% and 42%, respectively. Esophagitis was less severe than expected and prophylactic enteral feeding tubes were not necessary. Additional effective systemic treatments are needed to reduce the development of distant metastases.
Safety and efficacy of paclitaxel plus carboplatin versus paclitaxel plus cisplatin in neoadjuvant chemoradiotherapy for patients with locally advanced esophageal carcinoma: a retrospective study. [2023]We evaluated and compared the efficacy and safety of chemotherapy with paclitaxel plus cisplatin (TP) or carboplatin (TC) in patients with locally advanced esophageal squamous cell carcinoma (LA-ESCC) who underwent neoadjuvant chemoradiotherapy (NCRT).
Cisplatin/Irinotecan versus carboplatin/paclitaxel as definitive chemoradiotherapy for locoregionally advanced esophageal cancer. [2018]To compare toxicities, disease control, and survival outcomes for patients treated with either cisplatin/irinotecan versus carboplatin/paclitaxel concurrent chemoradiotherapy for locally advanced esophageal cancer.
A Phase I study of capecitabine, carboplatin, and paclitaxel with external beam radiation therapy for esophageal carcinoma. [2015]Concurrent chemotherapy and radiation therapy (RT) are used to treat patients with esophageal cancer. The optimal combination of chemotherapeutic agents with RT is undefined. We evaluated a combination of capecitabine, carboplatin, and paclitaxel with RT in a phase I study.
Paclitaxel, carboplatin, and long-term continuous 5-fluorouracil infusion in the treatment of upper aerodigestive malignancies: preliminary results of phase II trial. [2015]We evaluated the efficacy and toxicity of a novel chemotherapy regimen that included paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ), carboplatin, and long-term, continuous-infusion 5-fluorouracil in the treatment of cancers of the upper aerodigestive tract. In the preoperative treatment of patients with localized esophageal cancer, we administered this regimen concurrently with radiation therapy. Thirty-eight patients with biopsy-proven cancers of the head and neck or esophagus entered this trial between January 1996 and November 1996. Patients with head and neck cancers considered curable with local treatment modalities were excluded. All patients received the following chemotherapy regimen: paclitaxel 200 mg/m2 via 1-hour intravenous infusion on days 1 and 21, carboplatin at an area under the concentration-time curve of 6.0 intravenously on days 1 and 21, and 5-fluorouracil 225 mg/m2/d via continuous infusion on days 1 to 42. Patients with localized esophageal cancer also received radiation therapy beginning on day 1 (1.8 Gy/d; total dose, 45 Gy). Patients were re-evaluated at week 6; responding patients received a repeat course of treatment, except for those with localized esophageal cancer, who underwent resection at week 10. Twenty-five of 29 evaluable patients had major responses to treatment. Four of five patients with locally advanced head and neck cancer had complete clinical responses, while eight of 11 patients with metastatic disease responded. All 13 evaluable patients with localized esophageal cancer underwent resection, and nine (69%) had a pathologic complete response. Toxicity was moderate, with brief grade 3/4 leukopenia occurring in 19 patients (66%). Esophagitis occurred in five of 13 patients receiving concurrent chemotherapy and radiation therapy, but was reversible and generally occurred during the last week of radiation therapy. Other grade 3/4 toxicity was uncommon. This novel regimen of paclitaxel, carboplatin, and long-term 5-fluorouracil infusion is feasible and highly active in patients with cancers of the upper aerodigestive tract. It can be used concurrently with radiation therapy before resection for localized esophageal cancer. The high overall response rates, and particularly the high pathologic complete response rates in resected patients with esophageal cancer, are encouraging and warrant further evaluation of this regimen.
Cisplatin/5-Fluorouracil (5-FU) Versus Carboplatin/Paclitaxel Chemoradiotherapy as Definitive or Pre-Operative Treatment of Esophageal Cancer. [2021]Purpose To determine the efficacy and toxicity of two standard chemotherapy regimens used concurrent with radiation for the treatment of esophageal cancer: cisplatin/5-fluorouracil (5-FU) and carboplatin/paclitaxel. Materials and methods We prospectively reviewed records of 364 patients with histologically confirmed stage I to IVA esophageal cancer receiving chemoradiotherapy (CRT) with or without resection. All patients received surgical evaluation and imaging at presentation as well as following completion of their course of CRT. Treatment and prognostic variables were compared across the two chemotherapy regimens. Results We identified 261 patients treated with concurrent carboplatin/paclitaxel (n = 133) or cisplatin/5-FU (n = 128). Weight loss during CRT was lower in patients receiving carboplatin/paclitaxel (median: 7.0 pounds; 4.1% body weight) vs. cisplatin/5-FU (median: 11.0 pounds; 6.5% body weight) (p
New developments in the treatment of esophageal cancer. [2019]Esophageal cancer is a rare but highly virulent malignancy in the United States and Western Europe, and adenocarcinoma of the esophagus has had the most rapid rate of increase of any solid tumor malignancy. Combined chemoradiotherapy is the standard of care in the nonsurgical management of esophageal cancer. Trials of preoperative chemotherapy followed by surgery have not shown a consistent benefit. Preoperative chemoradiotherapy followed by surgery continues to be actively studied in the surgical management of locally advanced esophageal cancer. Pathologic complete responses are seen in 20% to 40% of patients, with 5-year survival achieved in 30% to 35%. Newer agents, such as the taxanes and irinotecan, have been evaluated in combined chemoradiotherapy trials. These trials have shown promising antitumor activity and therapy tolerance, depending on the dose and schedule of therapy administered. Increasing the dose of radiotherapy, or adding a brachytherapy boost to chemoradiotherapy, has not improved the outcome of treatment in clinical trials. The advent of newer targeted therapies, including agents directed against growth factor receptor pathways, tumor angiogenesis, and tumor invasion and metastasis, is leading to a new generation of clinical trials combining these agents with conventional cytotoxic chemotherapy and radiation.