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NCT03448549
SOX Versus XELOX as Adjuvant Chemotherapy for Stage III Colorectal Cancer Patients
Phase 3 trial testing Oxaliplatin in Colorectal Cancer Stage III in 1,191 participants. Status unknown.
1 January 2021
Quick facts
| Lead sponsor | Peking University Cancer Hospital & Institute |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 1,191 |
| Start date | 1 January 2018 |
| Primary completion | 1 January 2021 |
| Estimated completion | 1 January 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Oxaliplatin (Oxaliplatin) — full drug profile →
- Tegafur，gimeracil and oteracil potassium
- Xeloda (capecitabine) — full drug profile →
Conditions studied
- Colorectal Cancer Stage III — all drugs for Colorectal Cancer Stage III →
- Adjuvant Chemotherapy — all drugs for Adjuvant Chemotherapy →
Sponsor
Peking University Cancer Hospital & Institute
Who can join
18 and older, any sex, with Colorectal Cancer Stage III or Adjuvant Chemotherapy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Fluorouracil combined with oxaliplatin are routinely recommended to patients with pathological stage III (p-stage III) colorectal cancer, leading to significant improvement of 5-year disease-free survival and overall survival (approximately 3.4% -4.2%) by by international guidelines such as the National Cancer Comprehensive Network. The Considerable proportion of patients suffer with hand-foot syndrome due to capecitabine as commonly prescribed. Meanwhile as another agent of fluorouracil, tegafur，gimeracil and oteracil potassium (short for TGOP) has been shown with similar effect and less adverse reaction. This study was designed to investigate the short-term and long-term safety and efficacy of TGOP-OX and XELOX regimens in colorectal cancer p-stage III patients who undergo curative surgery and adjuvant chemotherapy, and to explore the compliance and quality of life in patients treated with TGOP-OX regime.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Colorectal Cancer at the Crossroads: The Good, the Bad, and the Future of Platinum-Based Drugs.
Kee JX, Yau JNN, Kumar Muthuramalingam RP, Wang X, et al · · 2025 · cited 6× · PMID 40985211 · DOI 10.1021/acs.chemrev.5c00041
Verify or expand the search:
- PubMed search for NCT03448549
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Other Peking University Cancer Hospital & Institute trials
Trials by the same sponsor.
- NCT07527806 — Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET/CT Molecular Im · Phase 2 · not yet recruiting
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- NCT07417241 — SHR-A1811 vs Pyrotinib/Capecitabine in Trastuzumab-Resistant HER2+ Advanced Breast Cancer: A Randomized Study · Phase 2 · not yet recruiting
- NCT07470203 — Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer · not yet recruiting
- NCT07394192 — Short-Course Radiotherapy With Tumor-Draining Lymph Node Preservation Followed by PD-1 Inhibitors in pMMR/MSS Stage II-I · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03448549 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Peking University Cancer Hospital & Institute
- Last refreshed: 6 March 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03448549.
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