Phase II/III Study Compare Adjuvant Chemoradiotherapy, Radiotherapy and Surgery Alone for Esophageal Carcinoma
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ClinicalTrials.gov Identifier: NCT02279134 |
Recruitment Status :
Active, not recruiting
First Posted : October 30, 2014
Last Update Posted : April 3, 2020
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Condition or disease | Intervention/treatment | Phase |
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Esophageal Neoplasms Esophageal Cancer | Radiation: Adjuvant Chemoradiation Radiation: Adjuvant Radiation Drug: Paclitaxel Drug: Cisplatin or Nedaplatin | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 360 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II/III Study of Adjuvant Chemoradiotherapy, Radiotherapy After Surgery Versus Surgery Alone in Patients With Stage ⅡB-Ⅲ Esophageal Carcinoma |
Actual Study Start Date : | October 2014 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | December 2024 |
Arm | Intervention/treatment |
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No Intervention: Surgery alone
No adjuvant treatment after radical resection is developed in this arm
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Experimental: Adjuvant Chemoradiation
Adjuvant chemoradiation after radical resection is developed in this arm
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Radiation: Adjuvant Chemoradiation
Patients receive Paclitaxel 135-150mg/m2 (D1 and D29) and Cisplatin or Nedaplatin 50-75mg/m2 (D1 and D29) every 4 weeks, concurrent with radiotherapy. Prophylactic polyethylene glycol recombinant human G-CSF is administered 48 hours after chemotherapy. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Drug: Paclitaxel 135-150mg/m2 (D1 and D29) Drug: Cisplatin or Nedaplatin 50-75mg/m2 (D1 and D29) |
Active Comparator: Adjuvant Radiation
Adjuvant radiation after radical resection is developed in this arm
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Radiation: Adjuvant Radiation
Patients undergo radiotherapy once daily 5 days a week for an average of 5.5 weeks within 12 weeks after surgery in the absence of disease progression or unacceptable toxicity. |
- Disease-free survival (DFS) [ Time Frame: up to 3 years ]From the date of randomization to the date of first failure or last follow-up
- Overall survival (OS) [ Time Frame: up to 5 years ]From the date of randomization to the date of death or last follow-up
- Adverse events [ Time Frame: up to 5 years ]From the date of randomization to the date of death or last follow-up
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Ages Eligible for Study: | 18 Years to 68 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- KPS≥70
- Diagnosis of stage ⅡB or Ⅲ thoracic esophageal cancer
- Complete resection
- Adequate organ function:
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
Exclusion Criteria:
- Uncontrolled diabetes
- Interval between surgery and adjuvant therapy more than 3 months
- Sign of recurrence on CT scan or ultrasound or PET-CT No palpable subclavicular lymph nodes or involvement after cytology needle aspiration No lymph nodes greater than 1 cm on CT scan
- With Weight loss greater than 10% from baseline
- With other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
- Be pregnant
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): NCT02279134
China, Beijing | |
Cancer Institute and Hospital, Chinese Academy of Medical Science | |
Beijing, Beijing, China, 100021 |
Principal Investigator: | Zefen Xiao, MD | Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Science |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Zefen Xiao, Chinese Academy of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT02279134 |
Other Study ID Numbers: |
14-090/880 |
First Posted: | October 30, 2014 Key Record Dates |
Last Update Posted: | April 3, 2020 |
Last Verified: | April 2020 |
StageⅡB-Ⅲ esophageal cancer adjuvant radiotherapy adjuvant chemoradiotherapy |
Esophageal Neoplasms Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases |
Paclitaxel Nedaplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |