Adjuvant Treatment of Concurrent RT and CAPOX or Capecitabine Alone for Stage II and III Rectal Cancer
Prospective Randomized Phase III Study of Concurrent Capecitabine and Radiotherapy With or Without Oxaliplatin as Adjuvant Treatment for Stage II and III Rectal Cancer
Sponsor: Beijing Hospital
Listed as NCT00714077, this observational or N/A phase trial focuses on Rectal Neoplasms and remains ongoing. Sponsored by Beijing Hospital, it has been updated 10 times since 2008, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)Adjuvant 5-FU based concurrent chemoradiotherapy and chemotherapy is the standard care for locally advanced stage II-III rectal cancer, based on several randomized Phase III clinical trials. With this standard treatment, 5-year local failure rate and distant metastasis rate is 10% and around 35%, respectively. Capecitabine, an analog of 5-fluoruracil (5FU), was demonstrated to have similar treatment results compared to 5-FU, but have much lower toxicities. Oxaliplatin based chemotherapy, also showed a better disease-free survival rate compared with 5-FU based-regimen. So far, some Phase I/II studies have shown the safety and preliminary results of either concurrent chemotherapy of capecitabine or oxaliplatin and capecitabine. The long-term results in comparison of capecitabine concurrent chemoradiotherapy with oxaliplatin/capecitabine concurrent chemoradiotherapy need to be further analyzed.
Adjuvant 5-FU based concurrent chemoradiotherapy and chemotherapy is the standard care for locally advanced stage II-III rectal cancer, based on several randomized Phase III clinical trials. With this standard treatment, 5-year local failure rate and distant metastasis rate is 10% and around 35%, respectively. Capecitabine, an analog of 5-fluoruracil (5FU), was demonstrated to have similar treatment results compared to 5-FU, but have much lower toxicities. Oxaliplatin based chemotherapy, also showed a better disease-free survival rate compared with 5-FU based-regimen. So far, some Phase I/II studies have shown the safety and preliminary results of either concurrent chemotherapy of capecitabine or oxaliplatin and capecitabine. The long-term results in comparison of capecitabine concurrent chemoradiotherapy with oxaliplatin/capecitabine concurrent chemoradiotherapy need to be further analyzed.
Status Flow
Change History
10 versions recorded-
Jan 2026 — Present [monthly]
Unknown
-
Sep 2024 — Present [monthly]
Unknown
-
Jul 2024 — Sep 2024 [monthly]
Unknown
Status: Unknown Status → Unknown
-
Oct 2023 — Jul 2024 [monthly]
Unknown Status
-
Dec 2022 — Oct 2023 [monthly]
Unknown Status
▶ Show 5 earlier versions
-
Jan 2021 — Dec 2022 [monthly]
Unknown Status
-
Jul 2018 — Jan 2021 [monthly]
Unknown Status
Status: Recruiting → Unknown Status
-
Jun 2018 — Jul 2018 [monthly]
Recruiting
-
Apr 2018 — Jun 2018 [monthly]
Recruiting
Phase: PHASE3 → None
-
Jan 2017 — Apr 2018 [monthly]
Recruiting PHASE3
First recorded
Apr 2008
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Beijing Hospital
- Cancer Hospital of Guizhou Province
- Chinese Academy of Medical Sciences
- General Hospital of Chinese Armed Police Forces
- Hebei Medical University Fourth Hospital
- Peking University Third Hospital
- Shandong Cancer Hospital and Institute
- Zhejiang Cancer Hospital
For direct contact, visit the study record on ClinicalTrials.gov .