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Completed

NCT Number: NCT03666442

Early Evaluation of Chemosensitivity for Low/Intermediated-risk Mid-low Stage II/III Rectal Cancer

Chemosensitivity of rectal cancer is not discussed clearly. With previous study, the investigators design this phase II trial to explore the effect of 2 cycles Xelox chemotherapy,so as to explore the early detection of sensitivity of tumor. With inclusion of early,intermediate,and bad stage II/III rectal cancer patients, four cycle of Xelox chemotherapy was given. After the second cycle, MRI,TRUS,DE,endoscopy,and blood DNA test was down to compare with these characteristics of four cycles.so that to detect the data about the chemosensitivity of tumor in the early stage.

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Guoxue Road 37#,West China Hospital

Chengdu, Sichuan, 610041, China

About this study

Chemosensitivity of rectal cancer is not discussed clearly. With previous study, the investigators design this phase II trial to explore the effect of 2 cycles Xelox chemotherapy,so as to explore the early detection of sensitivity of tumor. With inclusion of early,intermediate,and bad stage II/III rectal cancer patients, four cycle of Xelox chemotherapy was given. After the second cycle, MRI,TRUS,DE,endoscopy,and blood DNA test was down to compare with these characteristics of four cycles.so that to detect the data about the chemosensitivity of tumor in the early stage.In future, a phase III trial that explore the effect of radiation or surgery in these chemoresistant patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • .endoscopy and biopsy verified rectal cancer within 12cm from anal verge;
  • .primary MRI, TRUS, abdomino-chest CT diagnosed early or intermediate or bad Stage II/III rectal cancer;
  • .age from 20-75;
  • .with informed consent;

Exclusion criteria

  • .refuse the further treatment after recruiting;
  • .diagnosis of peritoneal metastasis in the surgery;

Treatment and study plan

XELOX

Drug

Xelox chemotherapy,that oxaliplatin 130mg/m2 d1,capecitabine 1000mg/m2 twice daily d1-14,every 3 weeks

Primary outcomes

  1. tumor volume

    Time frame: At the end of Cycle 2 (each cycle is 3 weeks)

    tumor volume measured by MRI

  2. tumor area in endoscopy

    Time frame: At the end of Cycle 2 (each cycle is 3 weeks)

    tumor area measured in endoscopy

  3. tumor volume

    Time frame: At the end of Cycle 4 (each cycle is 3 weeks)

    tumor volume measured by MRI

  4. tumor area in endoscopy

    Time frame: At the end of Cycle 4 (each cycle is 3 weeks)

    tumor area measured in endoscopy

Secondary outcomes

  1. blood DNA test

    Time frame: At the end of Cycle 2 (each cycle is 3 weeks)

    blood DNA test

  2. blood DNA test

    Time frame: At the end of Cycle 4 (each cycle is 3 weeks)

    blood DNA test

  3. tumor thickness in TRUS

    Time frame: At the end of Cycle 4 (each cycle is 3 weeks)

    tumor thickness in TRUS

  4. tumor thickness in TRUS

    Time frame: At the end of Cycle 2 (each cycle is 3 weeks)

    tumor thickness in TRUS

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

Early Evaluation of Chemosensitivity for Low-risk Stage II/III Rectal Cancer

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Sep 11, 2018
Registry last updated
Apr 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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