A Phase 3 interventional study of cisplatin and epirubicin hydrochloride in Esophageal Cancer and Gastric Cancer, sponsored by Alliance for Clinical Trials in Oncology. Completed at 535 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-07.
Sponsored by Alliance for Clinical Trials in Oncology · Phase 3, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy 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 after surgery may kill any remaining tumor cells following surgery. It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating stomach or esophageal cancer.
PURPOSE: Randomized phase III trial to compare two different chemotherapy and radiation therapy regimens in treating patients who have undergone surgery for stomach or esophageal cancer.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to depth of tumor penetration (T1 or T2 vs T3 vs T4), lymph node involvement (0 vs 1-3), and extent of lymphadenectomy (D1 or D2 vs D0 or unknown). Patients are randomized to 1 of 2 treatment arms.
Patients are followed every 3 months for 2 years, every 4 months for 2 years, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 824 patients will be accrued for this study.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's enrollment of 546 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Required Tumor Parameters
1.1 Patients must have histologically diagnosed adenocarcinoma of the stomach or gastroesophageal junction. Adenocarcinomas of the esophagus that are not involving the gastroesophageal junction are not eligible.
1.2 Patients must have had en bloc resection of all known tumor. The surgical resection must have been done with a curative intent.
1.3 Patients must have tumor extension beyond muscularis propria and/or nodal involvement without evidence of M1 disease.
1.4 Patients with known unresected cancer, recurrent cancer, microscopic evidence of tumor at the distal or proximal line of stomach resection, noncontiguous resection of tumor, or M1 (metastatic) disease are ineligible.
Prior Therapy
2.1 No prior therapy (except hormonal or biologic) for other malignancies is allowed except for adequately treated basal cell or squamous cell skin cancer, noninvasive carcinoma in situ which has been fully resected, or other cancer for which the patient has been disease free for five years.
2.2 Patients who have had any previous chemotherapy or radiotherapy are ineligible.
Patient Characteristics
3.1 Patients must have an ECOG (CTC) performance status of 0, 1 or 2.
3.2 Patients are required to have an adequate total caloric intake to allow them to maintain their post-surgical body weight. Patients must have documentation of stable weight (or less than 2 pounds weight loss) for at least one week prior to registration.
3.3 All patients must be evaluated by a radiation oncologist (prior to enrollment) to ensure that the patient is an appropriate candidate for radiation therapy.
3.4 Patients may not have unilateral renal function (only one functioning kidney) as determined by CT scan with contrast, urogram, renal scan, or other study.
3.5 Pregnant or lactating women may not participate. Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method or practice abstinence while in this study.
3.6 Patients with any of the following cardiac conditions are ineligible:
3.7 No uncontrolled serious medical or psychiatric illness which would prevent compliance with treatment or adequate informed consent.
3.8 Patients with active infectious process are ineligible.
3.9 Patients with grade 2 or greater peripheral neuropathy at baseline are ineligible.
Required Initial Laboratory Values:
Patients receive leucovorin calcium IV and fluorouracil (5-FU) IV on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.
Drug: fluorouracil · Drug: leucovorin calcium · Radiation: radiation therapy
Patients receive epirubicin IV over 3-15 minutes and cisplatin IV over 1 hour on day 1 and 5-FU IV continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.
Drug: cisplatin · Drug: epirubicin hydrochloride · Drug: fluorouracil · Radiation: radiation therapy
Given IV
Given IV
Given IV
Given IV
Given 5 days a week for 5 weeks
Overall Survival
Overall survival is defined as the time from study enrollment to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
Time frame: From study enrollment until death from any cause; up to 3 years
Disease Free Survival
Disease free survival is defined as the time from the date of study enrollment to death or documented second primary tumor, or cancer recurrence.The distribution of disease free survival time will be estimated using the method of Kaplan-Meier.
Time frame: From the date of study enrollment until death or documented second primary tumor, or cancer recurrence; up to 4 years
| Milestone | Arm I (5-FU/LV) | Arm II (ECF) |
|---|---|---|
| Started | 280 | 266 |
| Completed | 280 | 266 |
| Not completed | 0 | 0 |
Overall survival is defined as the time from study enrollment to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
| years | Arm I (5-FU/LV) | Arm II (ECF) |
|---|---|---|
| Overall Survival | 3.6 (2.8 to 4.9) | 3.5 (2.5 to 5.0) |
Disease free survival is defined as the time from the date of study enrollment to death or documented second primary tumor, or cancer recurrence.The distribution of disease free survival time will be estimated using the method of Kaplan-Meier.
| years | Arm I (5-FU/LV) | Arm II (ECF) |
|---|---|---|
| Disease Free Survival | 2.7 (1.9 to 3.8) | 2.3 (1.5 to 3.1) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I (5-FU/LV) | 11/272 (4%) | 62/272 (22.8%) | 258/272 (94.9%) |
| Arm II (ECF) | 5/251 (2%) | 42/251 (16.7%) | 234/251 (93.2%) |
| Event | Arm I (5-FU/LV) | Arm II (ECF) |
|---|---|---|
| NauseaGastrointestinal disorders | 40/272 | 19/251 |
| FatigueGeneral disorders | 32/272 | 25/251 |
| DiarrheaGastrointestinal disorders | 31/272 | 10/251 |
| Abdominal painGastrointestinal disorders | 27/272 | 9/251 |
| AnorexiaMetabolism and nutrition disorders | 27/272 | 16/251 |
| Mucositis oralGastrointestinal disorders | 26/272 | 5/251 |
| Neutrophil count decreasedInvestigations | 25/272 | 20/251 |
| Leukocyte count decreasedInvestigations | 24/272 | 19/251 |
| VomitingGastrointestinal disorders | 22/272 | 15/251 |
| DehydrationMetabolism and nutrition disorders | 16/272 | 9/251 |
| Event | Arm I (5-FU/LV) | Arm II (ECF) |
|---|---|---|
| FatigueGeneral disorders | 201/272 | 190/251 |
| NauseaGastrointestinal disorders | 192/272 | 176/251 |
| Leukocyte count decreasedInvestigations | 177/272 | 177/251 |
| Neutrophil count decreasedInvestigations | 178/272 | 166/251 |
| DiarrheaGastrointestinal disorders | 162/272 | 120/251 |
| Mucositis oralGastrointestinal disorders | 155/272 | 107/251 |
| AnorexiaMetabolism and nutrition disorders | 148/272 | 140/251 |
| VomitingGastrointestinal disorders | 123/272 | 120/251 |
| Abdominal painGastrointestinal disorders | 109/272 | 94/251 |
| Platelet count decreasedInvestigations | 92/272 | 74/251 |
| Age, Continuous(years) | Arm I (5-FU/LV) | Arm II (ECF) | Total |
|---|---|---|---|
| Median | 59 (23 to 81) | 58 (29 to 83) | 58.6 (23 to 83) |
| Sex: Female, Male(Participants) | Arm I (5-FU/LV) | Arm II (ECF) | Total |
|---|---|---|---|
| Female | 87 | 88 | 175 |
| Male | 193 | 178 | 371 |
| Region of Enrollment(participants) | Arm I (5-FU/LV) | Arm II (ECF) | Total |
|---|---|---|---|
| Canada | 21 | 17 | 38 |
| United States | 259 | 249 | 508 |
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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Alliance for Clinical Trials in Oncology