S-1 and Radiotherapy for Elderly Esophageal Cancer Patients

• Sponsor: Zhejiang Provincial People's Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02716688
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Arm: 1
• Duration (Months): 59
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

To investigate the efficacy and toxicity of S-1 with concurrent radiotherapy in older patients with esophageal cancer.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer; S-1; Radiotherapy	Drug: S-1; Radiation: radiotherapy	Phase 2

Detailed Description

Older patients with esophageal cancer have been correlated with poor prognosis because of having little chance to receive aggressive local therapy, including concurrent chemoradiotherapy. In this phase II trial, the efficacy and toxicity of S-1 with concurrent radiotherapy will be investigated in this setting.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 38 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase Ⅱ Study of S-1 With Concurrent Radiotherapy in Elderly Esophageal Cancer Patients
• Study Start Date: Jan 1, 2016
• Anticipated Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Radiotherapy and S-1 arm Radiotherapy will be delivered with a daily fraction of 1.8 Gy to a total dose of 50.4 Gy. Preplanned concurrent S-1 (70mg/m²/day) will be administered on Day 1 for 14 days, every 3 weeks. After dCRT, maintenance S-1 will be given up to two cycles.

Drug: S-1; S-1 will be administered orally twice daily for 14 days at a dose of 70 mg/m2/day with concurrent radiotherapy for 2 cycles. Patients who showed a response greater than that of stable disease underwent additional S-1 until disease progression, serious adverse events, or patient refusal up to four cycles.; Radiation: radiotherapy; Radiotherapy wiil be delivered with a daily fraction of 1.8 Gy to a total dose of 50.4 Gy.; Other Names: Irradiation

Outcome Measures

Primary Outcome Measures

1. response rate [week 4]

   Response rate will be done after 4 weeks following the last radiotherapy session.

Secondary Outcome Measures

1. Progression-free survival [year 0 - year 2]

   Progression-free survival (PFS) will be calculated from the date of CCRT initiation to the date of documented failure (local recurrence or metastasis occurrence) or the date of the last follow-up for those remaining.

2. Acute and late toxicities assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0) [year 0 - year 1]

   Acute and late toxicities will be assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0).

3. Overall survival [year 0 - year 2]

   Overall survival (OS) wiil be determined as the time (in months) between the first day of therapy and the last follow-up or the date of death.

Other Outcome Measures

1. Dysphagia score [month 0 - month 6]

   Dysphagia score was measured according to the following scale: 0, able to consume a normal diet; 1, able to swallow certain solid foods; 2, able to swallow only semisolid foods; 3, able to swallow liquids only; and 4, unable to swallow anything.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Cytologically or histologically confirmed esophageal carcinoma;

2. ECOG performance status: 0-1;

3. No treatments prior to enrollment;

4. At least one measurable lesion on CT, MRI or esophageal barium exam;

5. Normal functions of heart, lung, liver, kidney and bone marrow;

6. Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL;

7. Informed consent signed.

Exclusion Criteria:

1. Prior treatments of chemotherapy or irradiation;

2. Poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable;

3. Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis;

4. Participating in other clinical trials;

5. Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities;

6. The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

• Zhejiang Provincial People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shiliang Lv, MD, Zhejiang Provincial People's Hospital
• ClinicalTrials.gov Identifier: NCT02716688
• Other Study ID Numbers: ZhejiangPPH02
• First Posted: Mar 23, 2016
• Last Update Posted: Jun 20, 2019
• Last Verified: Jun 1, 2019

• Keywords provided by Shiliang Lv, MD, Zhejiang Provincial People's Hospital: Esophageal cancer; Radiotherapy; elder; S-1
• Additional relevant MeSH terms: Esophageal Neoplasms

Study Results

No Results Posted as of Jun 20, 2019