Radiation Therapy and Combination Chemotherapy With or Without Surgery in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed By Surgery
Recruitment status was Active, not recruiting
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Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain.
PURPOSE: This randomized phase III trial is studying radiation therapy together with combination chemotherapy to see how well they work with or without surgery in treating patients with locally advanced esophageal cancer that can be removed by surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer |
Drug: cisplatin Drug: fluorouracil Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Randomized Study of Adjuvant Radiochemotherapy After Surgery Versus Radiochemotherapy Alone in Patients With Locally Advanced Esophageal Cancer |
| Estimated Enrollment: | 40 |
OBJECTIVES:
- Compare the survival of patients with locally advanced esophageal cancer treated with neoadjuvant radiotherapy and chemotherapy comprising fluorouracil and cisplatin followed by surgery or radiotherapy and chemotherapy.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to gender, histology (epidermoid vs glandular), response to induction therapy (complete vs partial), and tumor differentiation (little differentiated vs undifferentiated/good vs moderately differentiated).
- Induction therapy: All patients receive induction therapy comprising fluorouracil IV continuously over 24 hours on days 1-5 and cisplatin IV over 1 hour on days 1-5 or on day 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo radiotherapy twice daily on days 1-5 and 22-26 or once daily 5 days a week for 4½ weeks. Patients achieving complete or partial response are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo surgery. Patients may receive 1 course of adjuvant chemotherapy (as in induction therapy) and undergo additional radiotherapy.
- Arm II: Patients receive additional fluoroucacil and cisplatin as in induction therapy. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo additional radiotherapy once daily 5 days a week for 2 weeks.
Quality of life is assessed at baseline, after treatment on arms I or II, and then every 2 months (arm I) or every 6 months (arm II) thereafter.
After completion of study therapy, patients are followed periodically.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed epidermoid or glandular cancer of the esophagus meeting the following criteria:
- Tumor volume with or without mediastinal adenopathy, celiac, or subclavicular involvement
- T3, N0-N1 disease
- Tumor extends into fifth stratum by endosonographic scan
- Resectable disease (palliative or curative)
- No cervical tumor
- No T1, T2, or T4 tumors
- No tracheo-esophageal fistula or tracheal invasion
- No gastric cardia cancer by gastroscopy
- No visceral (e.g., lung, bone, brain, liver), ganglion, or clavicular metastases
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Creatinine normal
- WBC ≥ 3,000/mm^3
- Neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Transaminases ≥ 60%
- Bilirubin ≤ 2.0 mg/dL
- No cirrhosis
- DLCO ≥ 1.5 L with or without hypoxemia at rest
- No progressive coronary insufficiency
- Weight loss ≤ 15%
- No other malignancy in the past 2 years
Must be able to maintain sufficient enteral nutrition (2,000 calories/day)
- Laser photodestruction, dilation, or gastric balloon allowed
- No contraindication to radiotherapy
- No recurring left paralysis
PRIOR CONCURRENT THERAPY:
- No concurrent nephrotoxic or myelotoxic drugs
Contacts and Locations More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00416858 History of Changes |
| Other Study ID Numbers: | CDR0000453783, FFCD-9102, EU-20539, ESSAI-FFCD-9102 |
| Study First Received: | December 27, 2006 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage III esophageal cancer |
Additional relevant MeSH terms:
|
Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Adjuvants, Immunologic Cisplatin |
Fluorouracil Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Radiation-Sensitizing Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents |
ClinicalTrials.gov processed this record on May 21, 2013