What side effects are associated with this type of intervention?

Common treatments for esophageal cancer, such as carboplatin and paclitaxel chemotherapy, are associated with several side effects. Hematologic toxicities like neutropenia, thrombocytopenia, and anemia are frequent, leading to an increased risk of infection and bleeding. Paclitaxel often causes neurotoxicity, including peripheral neuropathy. Patients may also experience nausea, vomiting, and general immunosuppression, which can significantly affect their quality of life. Managing these side effects is crucial for maintaining patient well-being during treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for esophageal cancer that involve platinum-based chemotherapy agents and taxanes. Carboplatin, which causes DNA crosslinking, and paclitaxel, which stabilizes microtubules to prevent cell division, are commonly used in combination for this purpose. Other similar FDA-approved treatments include cisplatin, another platinum-based drug, often used in combination with 5-fluorouracil (5-FU) or docetaxel, a taxane similar to paclitaxel. These combinations aim to improve patient outcomes by leveraging the synergistic effects of DNA damage and inhibition of cell division.

What other types of research exist?

Promising alternatives to Carboplatin and Paclitaxel chemotherapy for esophageal cancer include the combination of Paclitaxel and Nedaplatin, which has shown promising activity and good tolerability in advanced esophageal cancer. Additionally, the combination of Paclitaxel and Cisplatin has demonstrated significant activity, although it is associated with severe toxicity. Another potential approach is the addition of Carboplatin and Paclitaxel to palliative radiation therapy, which has been shown to improve dysphagia relief and quality of life in patients with unresectable esophageal cancer.

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Alkylating agents, Anti-tumor antibiotic

Chemoradiotherapy for Esophageal Cancer (PaRCUS Trial)

Phase 2

Recruiting

Led By Marc Kerba, MD

Research Sponsored by AHS Cancer Control Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Biopsy proven carcinoma of the esophagus

Not a candidate for radical/curative treatment due to the advanced nature of the disease, presence of metastases, or intercurrent illness

Must not have

Previous radiotherapy delivered to the chest

Synchronous active malignancies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if adding certain chemotherapy drugs to radiation therapy can better relieve swallowing difficulties and improve quality of life for patients with advanced esophageal cancer who can't undergo surgery. These drugs are commonly used in treatment for esophageal cancer and have shown promising results in various studies.

Who is the study for?

This trial is for adults with advanced esophageal cancer who can eat some solids, have a decent performance status, and proper organ function. They must start treatment within two weeks of consent, not be pregnant or breastfeeding, use effective contraception, and cannot have had previous chest radiation or chemotherapy for esophageal cancer.

What is being tested?

The study tests if adding carboplatin and paclitaxel (chemotherapy drugs) to external beam radiation improves swallowing difficulties and life quality in patients with inoperable esophageal cancer compared to radiation alone.

What are the potential side effects?

Possible side effects include nausea, vomiting, hair loss from chemotherapy; fatigue from both treatments; lowered blood counts leading to increased infection risk; kidney or liver stress shown by lab tests; and potential damage to nearby organs from radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My esophageal cancer has been confirmed by a biopsy.

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My condition cannot be cured due to its advanced stage or other health issues.

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I can only eat some solid foods due to my swallowing difficulty.

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I am 18 years old or older.

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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation therapy to my chest before.

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I have more than one type of cancer at the same time.

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I cannot undergo certain treatments due to my health condition.

Select...

I have a connection between my windpipe and esophagus.

Select...

I have had chemotherapy for esophageal cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients who achieve relief of dysphagia

Secondary study objectives

Dysphagia progression free survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Chemotherapy with Concurrent RadiationExperimental Treatment2 Interventions

Carboplatin and paclitaxel will be administered intravenously on Days 1 and 8 while radiation therapy is administered

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

External Beam Radiation

2014

Completed Phase 2

~70

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Carboplatin and Paclitaxel are common treatments for esophageal cancer. Carboplatin causes DNA crosslinking, which prevents DNA replication and transcription, leading to cell death. Paclitaxel stabilizes microtubules, preventing their disassembly, which is crucial for cell division, thereby halting the cell cycle and inducing apoptosis. These mechanisms are important for esophageal cancer patients as they target rapidly dividing cancer cells, reducing tumor growth and potentially improving symptoms and survival rates.