Phase 2
N=97
Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer
Esophageal Cancer · Gastric Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00033657 ↗Enrolled (actual)
97
Serious AEs
64.2%
Results posted
Jul 2011
Primary outcome: Primary: Pathologic Complete Response Rate — 15.4; 16.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cisplatin (Drug); irinotecan hydrochloride (Drug); paclitaxel (Drug); conventional surgery (Procedure); radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eastern Cooperative Oncology Group
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pathologic Complete Response Rate |
15.4; 16.7 | — |
| SECONDARY Overall Survival Time |
35.0; 21.0 | 0.48 |
| SECONDARY Recurrence-free Survival Time |
39.8; 12.4 | — |
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy before and after surgery may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of combining radiation therapy with two different chemotherapy regimens before and after surgery in treating patients who have esophageal cancer.
Eligibility Criteria
Inclusion Criteria
- Newly diagnosed adenocarcinoma of the esophagus (20 cm below incisors) or gastroesophageal junction
- Stage T2-3, N0, M0 OR
- Stage T1-3, N0-1, M0 or M1A (celiac nodal metastasis)
- Tumor must be considered surgically resectable (T1-3, but not T4)
- Age>=18 years
- ECOG Performance status 0-1
- Adequate hematopoietic, hepatic, renal functions defined by the following within 4 weeks prior to randomization:
- Granulocyte count at least 1,000/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 mg/dL
- Creatinine clearance at least 60 mL/min
- Prior curatively treated malignancy allowed if currently disease-free and survival prognosis is more than 5 years
- Fertile patients must use effective contraception
- Endoscopy with biopsy and dilation allowed
Exclusion Criteria
- Tumor extends more than 2 cm into the cardia
- Pregnant or nursing
- Other concurrent illness that would preclude study therapy or surgical resection
- Concurrent filgrastim (G-CSF) during study radiotherapy
- Prior chemotherapy
- Prior radiotherapy
- Prior surgery
Data sourced from ClinicalTrials.gov (NCT00033657). 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.