deltatrials
Unknown OBSERVATIONAL NCT00714077

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

Updated 10 times since 2017 Last updated: Feb 15, 2016 Started: Apr 30, 2008 Primary completion: Jan 31, 2018 Completion: Jun 30, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Jan 2017 – ~Apr 2018 · 15 months · monthly snapshotRecruiting~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotRecruiting~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshotRecruiting~Jul 2018 – ~Jan 2021 · 30 months · monthly snapshotUnknown Status~Jan 2021 – ~Dec 2022 · 23 months · monthly snapshotUnknown Status~Dec 2022 – ~Oct 2023 · 10 months · monthly snapshotUnknown Status~Oct 2023 – ~Jul 2024 · 9 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – present · 19 months · monthly snapshotUnknown~Jan 2026 – present · 3 months · monthly snapshotUnknown

Change History

10 versions recorded
  1. Jan 2026 — Present [monthly]

    Unknown

  2. Sep 2024 — Present [monthly]

    Unknown

  3. Jul 2024 — Sep 2024 [monthly]

    Unknown

    Status: Unknown StatusUnknown

  4. Oct 2023 — Jul 2024 [monthly]

    Unknown Status

  5. Dec 2022 — Oct 2023 [monthly]

    Unknown Status

Show 5 earlier versions
  1. Jan 2021 — Dec 2022 [monthly]

    Unknown Status

  2. Jul 2018 — Jan 2021 [monthly]

    Unknown Status

    Status: RecruitingUnknown Status

  3. Jun 2018 — Jul 2018 [monthly]

    Recruiting

  4. Apr 2018 — Jun 2018 [monthly]

    Recruiting

    Phase: PHASE3None

  5. 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

Sponsor contact:
  • 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
Data source: ChineseAMS

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations