Radiation Therapy and Paclitaxel, Carboplatin, and Fluorouracil Followed by Esophagectomy in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
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| ClinicalTrials.gov Identifier: NCT00022139 |
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Recruitment Status :
Completed
First Posted : March 7, 2003
Last Update Posted : December 7, 2016
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RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as paclitaxel, carboplatin, and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy with chemotherapy and giving them before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: This phase II trial is studying how well giving radiation therapy together with combination chemotherapy followed by esophagectomy works in treating patients with locally advanced cancer of the esophagus or gastroesophageal junction.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Esophageal Cancer Gastric Cancer | Drug: carboplatin Drug: fluorouracil Drug: paclitaxel Procedure: conventional surgery Radiation: radiation therapy | Phase 2 |
OBJECTIVES:
- Determine the pathologic complete response rate in patients with locally advanced cancer of the esophagus or gastroesophageal junction treated with radiotherapy administered concurrently with paclitaxel, carboplatin, and fluorouracil before esophagectomy.
- Determine the tolerability of this regimen in these patients.
- Determine the tumor response rate in patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Assess the relationship between the presence of genetic polymorphisms in these patients and the toxicity of this regimen.
OUTLINE: This is a multicenter study.
Patients receive carboplatin IV and paclitaxel IV over 3 hours on days 1 and 22 and fluorouracil IV continuously on days 1-42. Beginning on day 1 of chemotherapy, patients undergo radiotherapy to the esophagus 5 days a week for 5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease at 4-8 weeks after completion of radiotherapy undergo esophagectomy and complete dissection of the mediastinal and perigastric lymph nodes. Beginning 8 weeks after surgery, patients who underwent curative resection may receive a maximum of 2 additional courses of paclitaxel and carboplatin in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before chemotherapy on days 1 and 22, and within 2 weeks before surgery.
Patients are followed every 3 months for 4 years.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 56 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II Trial of Preoperative Radiation and Chemotherapy (Paclitaxel, Carboplatin, and Continuous Infusion 5-FU) for Locally Advanced Esophageal Cancer |
| Study Start Date : | January 2002 |
| Actual Primary Completion Date : | July 2005 |
| Actual Study Completion Date : | January 2009 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: carboplatin + paclitaxel + fluorouracil + radiation + surgery
Patients receive carboplatin IV and paclitaxel IV over 3 hours on days 1 and 22 and fluorouracil IV continuously on days 1-42. Beginning on day 1 of chemotherapy, patients undergo radiotherapy to the esophagus 5 days a week for 5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease at 4-8 weeks after completion of radiotherapy undergo esophagectomy and complete dissection of the mediastinal and perigastric lymph nodes. Beginning 8 weeks after surgery, patients who underwent curative resection may receive a maximum of 2 additional courses of paclitaxel and carboplatin in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, before chemotherapy on days 1 and 22, and within 2 weeks before surgery. Patients are followed every 3 months for 4 years. |
Drug: carboplatin Drug: fluorouracil Drug: paclitaxel Procedure: conventional surgery Radiation: radiation therapy |
- Proportion of successes [ Time Frame: Up to 4 years ]
- Toxicity-free rate [ Time Frame: Up to 4 years ]
- Clinical tumor response [ Time Frame: Up to 4 years ]
- Pathologic tumor response [ Time Frame: Up to 4 years ]
- Time to disease progression [ Time Frame: Up to 4 years ]
- Surgical outcome [ Time Frame: Up to 4 years ]
- Survival [ Time Frame: Up to 4 years ]
- Time to treatment failure [ Time Frame: Up to 4 years ]
- Quality of life [ Time Frame: Up to 4 years ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically or cytologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (below 20 cm) or gastroesophageal junction
- Surgically resectable disease (T1-3; NX, N0, or N1; M1a)
- T4 tumors that are not unequivocally unresectable allowed
- Celiac lymph node (stations 15-20) involvement allowed
- Must be considered a potential surgical candidate by a thoracic or general surgeon
- No supraclavicular lymph node involvement by palpation, biopsy, or radiograph (greater than 1.5 cm)
- No distant metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
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ECOG 0-2
- Patients with ECOG 2 must be considered good candidates for study by treating oncologists
Life expectancy
- At least 12 weeks
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST no greater than 3 times ULN
Renal
- Creatinine no greater than 1.5 times ULN
Cardiovascular
- No New York Heart Association class III or IV heart disease
Other
- No uncontrolled infection
- No other severe underlying disease that would preclude study participation
- No grade 2 or greater peripheral neuropathy
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for esophageal cancer
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy to anticipated fields of study radiotherapy
Surgery
- Not specified
Other
- No concurrent diuretics
- No concurrent amifostine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00022139
Show 35 study locations
| Study Chair: | Aminah Jatoi, MD | Mayo Clinic |
Other Publications:
| Responsible Party: | Alliance for Clinical Trials in Oncology |
| ClinicalTrials.gov Identifier: | NCT00022139 |
| Other Study ID Numbers: |
NCCTG-N0044 NCI-2012-02394 ( Registry Identifier: CTRP (Clinical Trials Reporting System) ) CDR0000068789 ( Registry Identifier: PDQ (Physician Data Query) ) |
| First Posted: | March 7, 2003 Key Record Dates |
| Last Update Posted: | December 7, 2016 |
| Last Verified: | December 2016 |
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stage III gastric cancer stage II esophageal cancer stage III esophageal cancer |
adenocarcinoma of the stomach squamous cell carcinoma of the esophagus adenocarcinoma of the esophagus |
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Stomach Neoplasms Esophageal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Head and Neck Neoplasms Esophageal Diseases Paclitaxel Carboplatin |
Fluorouracil Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |