NCT03607656CompletedPhase 2/3
The Effect of Traditional Chinese Treatment Combined Adjuvant Chemotherapy in IIIb and IIIc Gastric Cancer
The Effect of Traditional Chinese Treatment Combined Adjuvant Chemotherapy in IIIb and IIIc Gastric Cancer: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 18 Dec 2023
Brief summary (registry, in English)
This is a randomized, open-label study done in 3 hospitals in China. Patients with stage IIIB and IIIC gastric cancer who undergo curative D2 gastrostomy will be randomly assigned after surgery to receive adjuvant chemotherapy with oxaliplatin and capecitabine, or adjuvant chemotherapy combined Traditional Chinese treatment. The primary outcome was disease-free survival and 3-year disease-free survival rate in the intention-to-treat population.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 270 (actual)
- First submitted
- 1 Jul 2018
- Start date
- 8 Jun 2018
- Primary completion date
- 31 Oct 2022
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT03607656
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 270
- From 8 Jun 2018 to the primary completion date, 31 Oct 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Conversion chemotherapy before surgery;
- Concurrent cancer;
Other illness
- Women of gravid or lactating; patients with mental illness;
- Uncontrolled significant comorbid conditions.
Other
- Gastrectomy beyond D2, or TNM stage beyond Ⅲb and Ⅲc;
- Histological type beyond gastric carcinoma;
Who the study is looking for
- Histologically proven gastric carcinoma with radical operation, TNM (primary tumor, regional nodes, metastasis) stage IIIb or IIIc （The Eighth Edition American Joint Committee on Cancer \[AJCC\] gastric cancer staging）;
- Karnofsky performance status higher than 70;
- Adequate hepatic, renal, cardio and hematologic function;
- With patients' consent and comply to long term follow-up.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Longhua Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.