Phase 2
N=43
Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
Esophageal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00069953 ↗Enrolled (actual)
43
Serious AEs
63.4%
Results posted
Oct 2014
Primary outcome: Primary: Overall Survival (1-year Rate Reported) — 71 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- filgrastim (Biological); pegfilgrastim (Biological); cisplatin (Drug); fluorouracil (Drug); paclitaxel (Drug); conventional surgery (Procedure); radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Radiation Therapy Oncology Group
- Primary completion
- Mar 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (1-year Rate Reported) |
71 | — |
| SECONDARY Frequency of Major (Grade 4) Acute Treatment-related Toxicities |
— | — |
| SECONDARY Frequency of Patients With Persistent or Recurrent Disease Eligible for Surgical Salvage Resection |
— | — |
Summary
RATIONALE: Drugs used in chemotherapy such as paclitaxel, fluorouracil, and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells
PURPOSE: This phase II trial is studying how well combination chemotherapy followed by chemoradiotherapy, with or without surgery, works in treating patients with resectable locally advanced cancer of the esophagus or gastroesophageal junction.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction
- Primary (non-recurrent) disease
- Amenable to resection
- Stage greater than T1, N0 by endoscopic ultrasound
- Must be entirely confined to the esophagus or gastroesophageal junction and periesophageal soft tissue
- Tumor may not extend more than 2 cm into the stomach
- No multiple primary carcinomas of the esophagus
- No cervical esophageal carcinoma or tumors less than 5 cm from cricopharyngeus
- No evidence of disseminated cancer
- Suggestion of liver metastases by positron emission tomography must be proven negative by biopsy or other imaging studies
- Palpable supraclavicular nodes must be negative for cancer by biopsy
- Bronchoscopy required for lesions less than 26 cm from the incisors to exclude tracheoesophageal fistula or invasion
- No celiac adenopathy greater than 2 cm
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 150,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic
- Not specified
Renal
- Creatinine no greater than 1.5 mg/dL AND/OR
- Creatinine clearance at least 65 mL/min
- Calcium no greater than 11 mg/dL
Cardiovascular
- No uncontrolled heart disease
- No uncontrolled hypertension
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to comprehend study requirements and considered likely to comply with study parameters
- No other malignancy within the past 5 years except curable nonmelanoma skin cancer or carcinoma in situ of the cervix
- No uncontrolled diabetes
- No hypersensitivity to E. coli-derived products
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- More than 5 years since prior systemic chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior chest or upper abdomen radiotherapy
Surgery
- No prior esophageal or gastric surgery
Other
- No concurrent photodynamic therapy
- No other concurrent investigational agents for esophageal carcinoma
Data sourced from ClinicalTrials.gov (NCT00069953). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.